Rapportant au directeur principal, opérations cliniques, l’assistant aux essais cliniques fournira un soutien à l’équipe des opérations cliniques dans l’exécution de tous les aspects des activités d’essais cliniques et d’opérations réglementaires conformément aux ICH/BPC, aux réglementations applicables et aux SOP/politiques de 35Pharma.

Principales responsabilités :

– Fournir un soutien administratif général à l’équipe des opérations cliniques.

– Soutenir l’équipe des opérations cliniques dans la gestion des activités d’essais cliniques : préparer et distribuer les ordres du jour, les procès-verbaux et les présentations des réunions ; suivre et escalader les problèmes (le cas échéant) en temps opportun pour garantir une résolution rapide, etc.

– Mettre en place, maintenir et assurer l’exhaustivité des dossiers de formation spécifiques au projet.

– Gérer la préparation et la distribution des fournitures d’étude (les dossiers d’étude de l’investigateur (ISF), le matériel d’étude), si nécessaire.

– Distribuer l’information aux membres de l’équipe interne et aux parties prenantes externes (Organisation de recherche contractuelle ou (CRO), fournisseurs, sites).

– Maintenir divers outils et systèmes de suivi et de rapports nécessaires à l’équipe des opérations cliniques.

– Mettre en place et maintenir la base de données des investigateurs des opérations cliniques.

– Recueillir, suivre, et classer tous les documents essentiels des sites et autres documents cliniques requis dans le système électronique de classement des documents des essais cliniques (« electronic trial master file » ou eTMF), sous la direction du spécialiste TMF.

– Communiquer directement avec les CRO, les associés de recherche clinique, les sites et les autres membres de l’équipe interne pour garantir que tous les documents requis pour l’eTMF sont collectés et classés en temps opportun.

– Contacter les sites cliniques pour des demandes spécifiques (mises à jour des inscriptions, documentation manquante, etc.)

– Aider les gestionnaires de projet associés et les gestionnaires de projet cliniques à réviser les ententes contractuelles d’essais cliniques et les budgets des sites, créer un outil de suivi pour capturer les coûts par procédure par site et les paiements par site, et vérifier les demandes de paiement du site par rapport aux visites et aux procédures effectuées dans les dossiers d’études électroniques («electronic case report form » ou eCRF.

– Peut soutenir toute activité des opérations cliniques et réglementaires jugée nécessaire pour assurer le succès du programme clinique.

Qualifications:

– Au moins un baccalauréat en sciences de la santé ou diplôme connexe en sciences de la vie ou expérience équivalente.

– Au moins deux (2) ans d’expérience dans un rôle d’assistant d’essais cliniques ou de coordination de projets dans une entreprise pharmaceutique ou biotechnologique, ou une CRO.

– Flexible, indépendant et motivé.

– Excellentes compétences en communication orale et écrite.

– Capacité à prioriser, organiser, planifier et exécuter avec succès plusieurs tâches et priorités simultanément.

– Un engagement inébranlable envers la plus haute qualité de travail, l’éthique de la recherche et la volonté d’apprendre.

– Maîtrise démontrée des logiciels requis (Word, Excel, PowerPoint) et d’autres systèmes cliniques (CTMS, EDC, eTMF, QMS) et compétences informatiques.

Veuillez envoyer votre CV et une lettre de motivation décrivant votre motivation et votre expérience pertinente pour le poste à emplois@35pharma.com en indiquant « Affichage 35Pharma CTA0122» dans la ligne d’objet – nous avons hâte d’avoir de vos nouvelles !

Veuillez noter que le masculin est utilisé pour alléger le texte, et ce, sans préjudice pour la forme féminine.

Type d’emploi : Temps plein, Permanent

Avantages :

• Aide au Transport Quotidien
• Assurance Dentaire
• Assurance Invalidité
• Assurance Maladie Complémentaire
• Assurance Vie
• Assurance Vision
• Congés payés
• Événements d’Entreprise
• Heures d’arrivée et de départ flexibles
• Programme d’Aide aux Employés
• Programmes de Bien-être

Horaire :

• Du Lundi au Vendredi

Lieu du poste : En présentiel

Reporting to the Senior Director, Clinical Operations, the Clinical Trial Assistant provides support to the clinical operations team in the execution of all aspects of clinical trial and regulatory operations activities in accordance with International Council for Harmonisation (ICH): Guideline for Good Clinical Practice (GCP), applicable regulations, and 35Pharma Inc. standard operating procedures (SOP)/policies.

Key Responsibilities:

· Provide general administrative support to the clinical operations team.

· Support the clinical operations project team in the day-to-day management of clinical trial activities such as: prepare and distribute meeting agendas, minutes, and presentations; maintain action items and decisions logs; track and escalate issues (as appropriate) in a timely manner, etc.

· Set-up, maintain, and ensure project team members training records are in order and up to date.

· Manage preparation and distribution of study supplies (i.e., investigator site files (ISF), study material), as necessary.

· Distribute information to internal team members and external stakeholders (contract research organizations (CROs), vendors, sites).

· Maintain various tracking and reporting tools and systems needed by the clinical operations team.

· Maintain the clinical operations investigators database.

· Participate in the site feasibility and site selection process.

· Collect, track, and file sites essential documents and other required clinical documents for filing in the electronic trial master file (eTMF) under the guidance of the TMF Specialist.

· Update site-specific ISF checklist during the course of the study.

· Communicate directly with the CROs, clinical research associates, sites and other internal team members to ensure all documents required for the eTMF are collected and filed in a timely manner.

· Contact clinical sites for specific requests (i.e., enrollment updates, missing documentation, etc.).

· Assist the Associate Project Managers and Clinical Project Managers in the review of clinical trial agreements and site budgets, create tracking tool to capture costs per procedures per site and site payments, and verify site payment requests against visits and procedures completed in the electronic case report form (eCRF).

· May perform remote monitoring activities (i.e., remote source data verification (SDV) and data queries resolution, remote ISF review and reconciliation with TMF, etc.).

· May support any clinical and regulatory operations activities as deemed necessary to ensure the clinical program success.

Qualifications:

· Minimum of bachelor’s degree in health sciences or related degree within life sciences or equivalent experience.

· Minimum of 2 years’ experience in a clinical trial assistant, project coordination, or in-house CRA role in a pharmaceutical or biotechnology company, or a CRO. Previous on-site clinical monitoring experience an asset.

· Flexible, independent and self-motivated.

· Excellent oral and written communication skills.

· Ability to prioritize, organize, plan, and successfully execute multiple tasks and priorities simultaneously.

· An unwavering commitment to the highest quality of work, research ethics and willingness to learn.

· Demonstrated proficiency in required software (Word, Excel, PowerPoint) and other clinical systems (i.e., EDC, eTMF, Quality Management System (QMS)) and computer skills.

Please send your CV and cover letter outlining your motivation and relevant experience for the role to careers@35pharma.com quoting “35Pharma Posting CTA0122” in the subject line – we are looking forward to hearing from you!

Job Types: Full-time, Permanent

Benefits:

• Commuter benefits
• Company events
• Dental care
• Disability insurance
• Employee assistance program
• Extended health care
• Flexible schedule
• Life insurance
• Paid time off
• Vision care
• Wellness program

Schedule:

• Monday to Friday

Work Location: In person

Location: 48HD laboratories are located on campus of the University of Alberta in Edmonton, AB, Canada.

Job Type: Part-time Internship, On-going

Duties:

• Perform basic laboratory procedures including preparation of samples, reagents and calibration solutions.
• Provide general lab support including washing glassware, cleaning work stations and waste disposal.
• Calibrate, operate, maintain and troubleshoot intermediate instruments.
• Perform PCR reactions
• Other duties as assigned.

Qualifications:

· Degree or Diploma in Biological Science or a related field from a recognized post-secondary institute.

· Based in Edmonton, AB

· Must be eligible to work in Canada without sponsorship.

· Ability to be productive while working independently as well as in a team setting.

· Results-oriented and efficient, with excellent problem-solving skills.

· Strong interpersonal and communication skills, with an affinity for working respectfully with colleagues and clients at all levels.

· Proficient with computers and software, especially Microsoft Word, and Excel(at least an intermediate level of proficiency).

Job Types: Part-time, Internship / Co-op

Pay: From $20.00 per hour

Expected hours: No less than 10 per week

Flexible language requirement:

• French not required

Schedule:

• Evening shift
• Monday to Friday

Work Location: In person

Application deadline: 2025-02-07

About the Company

Diagnexia, a subsidiary of Deciphex: Accelerating Certainty and Pioneering Pathology Services.

Diagnexia, a leading provider of pathology services, operates as a subsidiary of the parent company, Deciphex. Established in Dublin in 2017, Deciphex has rapidly expanded to become a global team of over 190 professionals, offering innovative software solutions to address the pathology gap in both research and clinical areas. With a mission to accelerate the drug development process and provide timely, accurate diagnoses for cancer patients, Deciphex has established a strong presence through its offices in Dublin, Exeter, Oxford and Chicago.

As part of the Deciphex family, Diagnexia leverages its expertise to provide cutting-edge diagnostic solutions to healthcare organizations worldwide. Our cloud-based platform enables hospitals to easily and rapidly send cases for a consultation to our team of expert subspecialists. We are dedicated to improving patient outcomes and helping healthcare organisations stay at the forefront of the industry.

We are software developers, clinical specialists, AI engineers, operations professionals and so much more, all working as one team to support our customers and patients. Our team culture is built on trust. We give our team the space they need to deliver results and the environment to ensure they can enjoy doing it.

We are looking for a highly motivated individual who is excited to take on challenges and value making a difference in their day-to-day work. This is a unique opportunity to make a difference in the emerging Digital Pathology field.

About this Role

This role is advertised for a Laboratory Quality Officer, Oxford, is an experienced scientific and technical professional who has a good understanding of accredited histopathology laboratory operations both in the context of clinical trials and digital clinical laboratory and reporting services. In addition to their scientific, technical and administrative/managerial role), they will have responsibility for implementing, overseeing and promoting the laboratory quality management system in their area.

You will be successful in this role if you are proactive in taking initiative, you are adept in engaging diverse stakeholders, you are innovative with problem-solving, and you have a collaborative spirit within a team environment.

Responsibilities:

• Quality lead to support digital scanning and histopathology laboratory operations in the UK
• Develop and implement laboratory policies and procedures to ISO 15189:2022, GLP and IHC GCP requirements ensuring quality and integrity of laboratory data. Maintain UKAS accreditation for laboratory operations and services to ISO 15189:2022, ensuring compliance to these.
• Write new documents, procedures, work instructions as required with the laboratory team.
• Closely collaborate with project teams to expand and deliver new laboratory services.
• Work closely with clinical trial sponsors and CROs to align processes with ICH GCP guidelines.
• Lead and co-ordinate change management activities to document changes within the quality management system.
• Oversee document control within the laboratory; to ensure documents are reviewed in a timely manner; and that all documents issued are correctly controlled & managed in line with the document control procedure.
• Oversee the audit calendar for the laboratory; ensuring all internal and supplier audits are carried out in a timely manner, in liaison with the Operations Manager.
• Review all completed audits before they are submitted to the Quality Manager for acceptance, to ensure they have been completed to the required standard.
• Monitor laboratory audit non-conformance, CAPAs and error logs; liaise with the Operations Manager to ensure that actions are appropriately delegated and closed within the required timeframe.
• Compile error log reports on a monthly basis & provide monthly trend analysis for KPI reviews.
• Work closely with managers in providing advice and support to staff in the implementation of the quality management system, particularly in regards to documentation, training, audit and non-conformance management.
• Act as the point of contact for the Quality Manager within the laboratory, and ensure that any relevant instructions and information from the Quality Manager are disseminated.
• Ensure that all employees are aware of their responsibilities with regards to quality management; are adequately trained; and that all staff performing quality tasks have completed relevant competencies for performing such tasks.
• Act as the subject matter expert and point of contact for laboratory quality matters arising in the context of clinical trials, including supporting our customers with their regulatory audits for their clinical trials.
• Manage participation in the EQA schemes that the laboratory subscribes to, on behalf of the Operations Managers.
• Liaise regularly with the Operations Manager on quality management issues, identify areas of concern and take action where necessary. Share learning and good practice with the other services within the company.
• Work with the Operations Manager in the provision and collation of evidence for UKAS. Assisting the Quality manager with closing non conformities and implementing corrective actions.
• Co-ordinate regulatory audits of laboratory services as required, for example UKAS, MHRA.
• Support the development and implementation of AI-assisted pathology tools for clinical and preclinical use, ensuring regulatory acceptance as applicable.
• Support any other duties as assigned by quality management
• Periodic international traveling will be required to company sites, up to 10% travel will be required.
• Training required for the role may include ISMS, GLP, DocuSign and GDPR/HIPAA awareness.

Required Skills and Experience:

• Bachelor’s degree in Biomedical Science or similar Life Science qualification
• At least 5 years of experience in ISO 15189 accredited histopathology laboratories
• Strong knowledge of GLP regulations and current guidelines such as 21 CFR 58, 21 CFR 11, OECD Principles of GLP and/or of GCP regulations and current guidelines such as 21 CFR 50, 21 CFR 54, 21 CFR 56, 21 CFR 312.
• Experience with digital pathology and digital biomarkers
• Excellent communication, collaboration, and leadership skills
• Strong problem-solving and analytical skills.
• Ability to work under pressure and meet tight deadlines

Desirable Skills and Experience

• Experience with both GLP and GCP regulations will be ‘a distinct advantage’
• Knowledge of AI cloud computing, electronic data archiving is an advantage
• Experience with Gen AI tools is an advantage

Soft Skills

• You will have shown leadership skills in previous positions and are keen to develop these skills further by owning your role from end to end.
• You bring a sense of urgency to the work that you do and are able to execute on tasks by using your initiative.
• You enjoy innovating and bringing new ideas to the table.
• You like to have autonomy in your role and the independence to manage your own time and workload.
• You are highly collaborative and enjoy working with lots of different teams and people.
• You thrive in a fast paced environment and can manage changing priorities.
• You have great written and oral English language skills.

What are the benefits of working with Diagnexia?

• Competitive salary with performance based annual increments.
• Healthcare benefits
• Competitive annual leave
• A true sense of meaning in your work by contributing to better patient outcomes.
• The opportunity to work alongside a world-class high performing team in a hyper-growth startup environment.
• A chance to work on exciting,challenging and unique projects.
• Regular performance feedback and significant career growth opportunities.
• A highly collaborative and supportive multi cultural team.

Deciphex is an equal opportunities employer and we are committed to the principle of equality. All qualified applicants will be considered for employment without regard to age, race, religious beliefs, political views, gender identity, affectional or sexual orientation, national origin, family or marital status (including pregnancy), disability, membership of the travelling community or any other classification protected by applicable law.

About the Company

Through the work that we do, the team at Deciphex helps pharma to accelerate the process of essential drug development and helps patients to get timely and accurate diagnosis.

Founded in Dublin in 2017, Deciphex has scaled rapidly to a team of over 190 people and counting who are providing software solutions to address the pathology gap in research pathology and clinical areas. We have offices in Dublin, Exeter, Oxford, Toronto and Chicago and are expanding our team throughout the world.

We are software developers, clinical specialists, AI engineers, operations professionals and so much more, all working as one team to support our customers and patients. Our team culture is built on trust. We give our team the space they need to deliver results and the environment to ensure they can enjoy doing it.

We are looking for highly motivated individuals who are excited to take on challenges and value making a difference in their day-to-day work. This is a unique opportunity to make a difference in the emerging Digital Pathology field.

Read more about Deciphex here and more about our incredible team on our Careers Page here

Responsibilities:

• Oversee and manage the planning, execution, and delivery of integration and automation projects.
• Act as the primary point of contact for internal and external stakeholders, vendors, and external partners to coordinate project activities.
• Develop detailed project plans, including timelines, milestones, and resource allocation, to ensure projects meet key deadlines.
• Monitor project progress, identify risks, and implement mitigation strategies to keep projects on track.
• Ensure compliance with industry regulations and company standards for data integration and security.
• Manage communication with stakeholders to provide regular updates on project status, challenges, and achievements.
• Collaborate with technical teams to ensure seamless integration of software solutions with existing systems, such as LIMS, PACS, and other healthcare IT platforms.
• Conduct post-project evaluations to identify lessons learned and drive continuous improvement in project management practices.
• Prepare documentation, including project charters, scope definitions, and technical requirements.

Required Skills and Experience:

• Bachelor’s degree in Information Technology, Healthcare Management, or a related field. A Master’s degree or PMP certification is a plus.
• Proven experience as a Technical Project Manager, preferably in the healthcare or life sciences sector.
• Familiarity with healthcare IT systems like LIMS, PACS, and EHR platforms preferred.
• Exceptional organizational skills with a proven ability to manage multiple projects simultaneously.
• Excellent communication and stakeholder management skills to work effectively with technical and non-technical audiences.
• Demonstrated ability to identify, assess, and mitigate project risks effectively.
• Proficient in project management tools such as ClickUp, MS Project or equivalent.
• Strong analytical and problem-solving skills with a results-oriented mindset.
• Understanding of data privacy regulations and security practices in the healthcare industry, such as GDPR and HIPAA.
• Experience with automation tools and technologies is an advantage.

What are the benefits of working with Deciphex?

• Competitive salary with performance based annual increments.
• Healthcare benefits
• Competitive annual leave
• A true sense of meaning in your work by contributing to better patient outcomes.
• The opportunity to work alongside a world-class high performing team in a hyper-growth startup environment.
• A chance to work on exciting,challenging and unique projects.
• Regular performance feedback and significant career growth opportunities.
• A highly collaborative and supportive multi cultural team.

Deciphex is an equal opportunities employer and we are committed to the principle of equality. All qualified applicants will be considered for employment without regard to age, race, religious beliefs, political views, gender identity, affectional or sexual orientation, national origin, family or marital status (including pregnancy), disability, membership of the travelling community or any other classification protected by applicable law.

The Moredun Group are seeking an enthusiastic and conscientious Electrical Maintenance Engineer to join the team at Pentlands Science Park (PSP) which is home to the Moredun Group and a number of research organisations with a key focus on livestock health & welfare.

You will join a small team of in-house engineers and carry out both planned and reactive maintenance in an efficient and timely manner in a number of buildings including offices, laboratories and other research facilities. You will also be required to carry out any maintenance and repairs to electrical plant and equipment.

Experience required

You will have:

• A qualification and apprenticeship in Electrical Engineering
• Good knowledge of Health and Safety legislation
• Awareness of Electricity at Work and relevant codes of practice
• Knowledge of BS 7671 18th Edition standards
• Good problem solving and fault finding

The post is Monday to Friday and you will be required to participate in an on-call rota with the other engineers to provide cover to the park 24/7 for which you will receive an additional on-call allowance.

Staff benefits

In addition to access to training and development opportunities, you will have access to:

• Competitive pension scheme – a minimum contribution of 5% and Moredun contributing a maximum of 15%.
• 6 weeks annual leave plus 7 days public holidays and a privilege day
• Free access to an Employee Assistance Programme
• Benefits platform offering discounts at various retailers
• On site café.

Job Types: Full-time, Permanent

Pay: £30,000.00-£34,000.00 per year

Schedule:

• Monday to Friday
• Overtime

Work Location: In person

Reference ID: 01-01-25

About the Company

Diagnexia, a subsidiary of Deciphex: Accelerating Certainty and Pioneering Pathology Services.

Diagnexia, a leading provider of pathology services, operates as a subsidiary of the parent company, Deciphex. Established in Dublin in 2017, Deciphex has rapidly expanded to become a global team of over 190 professionals, offering innovative software solutions to address the pathology gap in both research and clinical areas. With a mission to accelerate the drug development process and provide timely, accurate diagnoses for cancer patients, Deciphex has established a strong presence through its offices in Dublin, Exeter, Oxford and Chicago.

As part of the Deciphex family, Diagnexia leverages its expertise to provide cutting-edge diagnostic solutions to healthcare organizations worldwide. Our cloud-based platform enables hospitals to easily and rapidly send cases for a consultation to our team of expert subspecialists. We are dedicated to improving patient outcomes and helping healthcare organisations stay at the forefront of the industry.

We are software developers, clinical specialists, AI engineers, operations professionals and so much more, all working as one team to support our customers and patients. Our team culture is built on trust. We give our team the space they need to deliver results and the environment to ensure they can enjoy doing it.

We are looking for highly motivated individuals who are excited to take on challenges and value making a difference in their day-to-day work. This is a unique opportunity to make a difference in the emerging Digital Pathology field.

About this Role (Responsibilities):

• Receive, accession, scan and digitize all stained slides and upload to the hub in preparation for pathologist review and reporting
  • QA all samples, transcription of data.
  • Register and maintain referring clinician and patient information related to a given referred case and institute
  • Return all physical materials (Blocks, slides, paper reports) to the referring laboratory upon issue of the individual case final report.
  • Ensure compliance with GDPR/CQC regulations, and maintain patient records in accordance with all data protection protocols
  • QC and review scan slides before upload to the Diagnexia hub ensuring documentation and formatting is correct.
  • Maintenance of the scanning document library.
  • Respond to incoming calls, voicemails, and email tickets requesting assistance with the technology platform
  • Basic troubleshooting of customer support problems
  • Track and document technical problems
  • Escalate technical issues to other team members when appropriate
• Assist with out of office hours support when required
• Assist with Research Pathology technical support as required
• Act as Responsible Person/Supervisor in absence of Manager/Level 3 Support Technician
• Delegation of lab tasks as assigned by Manager/in the absence of Manager
• Assist in training and onboarding tasks for New Hires
• Involvement in refinement of SOP’s
• GLP and other regulatory responsibilities (S.O / D.A.)
• Principal Investigator for Good Lab Practices
• Dedicated support for other functional roles
• Comply with applicable health and safety requirements

About You (Skills and Experience):

• A-level in a science subject required and/or scientific diploma, or relevant certification
• Demonstrated leadership skills and/or people management skills/qualification
• Strong communication skills

• Basic IT troubleshooting experience
• Experience working with an electronic documentation system
• Organized and diligent with activities

• Motivated and independent worker
• Good customer service skills and ability to work with various groups (internal and external customer base)
• Experience with GLP regulations or software
• Good time keeping skills and ability to meet timelines
• Proactive with improving document control and training process
• Willing to learn and be proactive in developing skills & experience
• You bring a sense of urgency to the work that you do and are able to execute on tasks by using your initiative
• You enjoy innovating and bringing new ideas to the table
• You like to have autonomy in your role and the independence to manage your own time and workload
• You are highly collaborative and enjoy working with lots of different teams and people
• You have great written and oral English language skills

What are the benefits of working with Diagnexia?

• Competitive salary with performance based annual increments.
• Healthcare benefits
• Competitive annual leave
• A true sense of meaning in your work by contributing to better patient outcomes.
• The opportunity to work alongside a world-class high performing team in a hyper-growth startup environment.
• A chance to work on exciting,challenging and unique projects.
• Regular performance feedback and significant career growth opportunities.
• A highly collaborative and supportive multi cultural team.

Deciphex is an equal opportunities employer and we are committed to the principle of equality. All qualified applicants will be considered for employment without regard to age, race, religious beliefs, political views, gender identity, affectional or sexual orientation, national origin, family or marital status (including pregnancy), disability, membership of the traveling community or any other classification protected by applicable law.

About the Company

Diagnexia, a subsidiary of Deciphex: Accelerating Certainty and Pioneering Pathology Services.

Diagnexia, a leading provider of pathology services, operates as a subsidiary of the parent company, Deciphex. Established in Dublin in 2017, Deciphex has rapidly expanded to become a global team of over 150 professionals, offering innovative software solutions to address the pathology gap in both research and clinical areas. With a mission to accelerate the drug development process and provide timely, accurate diagnoses for cancer patients, Deciphex has established a strong presence through its offices in Dublin, Exeter, Oxford and Chicago.

As part of the Deciphex family, Diagnexia leverages its expertise to provide cutting-edge diagnostic solutions to healthcare organizations worldwide. Our cloud-based platform enables hospitals to easily and rapidly send cases for a consultation to our team of expert subspecialists. We are dedicated to improving patient outcomes and helping healthcare organisations stay at the forefront of the industry.

We are software developers, clinical specialists, AI engineers, operations professionals and so much more, all working as one team to support our customers and patients. Our team culture is built on trust. We give our team the space they need to deliver results and the environment to ensure they can enjoy doing it.

We are looking for highly motivated individuals who are excited to take on challenges and value making a difference in their day-to-day work. This is a unique opportunity to make a difference in the emerging Digital Pathology field.

About this Role

As a Senior Biomedical Scientist at Diagnexia, you will play a pivotal role in spearheading our Digital Pathology projects, establishing yourself as a beacon of technical expertise within the realm of digital pathology. Your responsibilities will not only encompass the routine and specialist examination of samples but will also delve into advanced techniques and methodologies, ensuring the highest standards of accuracy and precision.

As a Senior Biomedical Scientist, you will be required to supervise other staff members and deputise for the Laboratory manager.

The ideal candidate for this role is an HCPC registered Biomedical Scientist who has successfully completed the Specialist Portfolio in Cellular Pathology, and has extensive post-specialist portfolio experience.

If you are a professional who thrives in an environment that values autonomy, has the capability to work unsupervised for extended periods, and is deeply committed to enhancing patient care through continuous improvement and innovation, then this role at Diagnexia is tailored for you.

Responsibilities:

Key tasks:

• Take responsibility for sections of the laboratory and supervise the performance of junior staff within the laboratory to ensure timely delivery of laboratory targets
• Develop and maintain the standard operating procedures for use within the laboratory in accordance with relevant regulatory standards (UKAS/ISO etc)
• Develop and maintain competency training documents for use within the laboratory in accordance with relevant regulatory standards
• Perform and evaluate staff training and competencies, and facilitate CPD for staff
• Take responsibility for own training and development and maintain expertise in all areas of histology (both practical and theoretical)
• Participate in staff interviews, selection process and appraisals
• Develop technical verification and validation protocols in accordance with relevant quality standards and carry out verification and validation of methods/analysers including appropriately documenting these
• Contribute to the laboratory quality management system and work with the quality manager and laboratory manager to ensure all staff within the Laboratory are working in accordance with relevant quality and laboratory protocols
• Develop and present reports at relevant meetings as well as facilitate and/or chair laboratory section or departmental meetings
• As part of the laboratory management team, take responsibility for ensuring that all activities within the laboratory sections are carried out in line with relevant laboratory code of practice, laboratory protocols including CoSHH/Health & Safety, and UKAS requirements.

Sample Collection and Handling:

• Collect and receive biological samples, such as blood, tissues, or body fluids, while ensuring proper labelling and storage.
• Maintain accurate records of sample collection, transportation, and storage conditions.
• Competently handle all steps of the specimen workflow including but not limited to; Accessioning, basic grossing, processing, embedding, microtomy, staining and digitisation of cases as required.

Quality Control and Quality assurance:

• Implement quality control measures to ensure the accuracy and reliability of test results.
• Troubleshoot and resolve technical issues to maintain the integrity of the testing process.
• Adhere to UKAS standards and participate in internal and external quality assurance programs and audits.
• Ensure junior staff are following relevant quality control and quality assurance procedures and follow up on any issues including escalation to the laboratory and/or quality manager as required.

Method Development and Validation:

• Develop and validate new laboratory methods and procedures as needed, following industry best practices and standards in accordance with UKAS 15189:2022 and NEQAS.

Research and Development:

• Engage in research activities to improve diagnostic techniques, including sample preparation for AI projects.

Safety and Compliance:

• Adhere to strict safety protocols to protect both laboratory personnel and patients.
• Ensure compliance with all relevant regulatory guidelines, including GDPR and UKAS

Documentation and Reporting:

• Maintain accurate and comprehensive records of all testing activities, including sample tracking, procedures, and results.
• Generate clear and concise reports for healthcare providers, pathologists, and other stakeholders.

Patient and Data Privacy:

• Maintain strict confidentiality of patient information and laboratory data, adhering to privacy laws and regulations.

Other:

• Collaborate with pathologists, medical staff, and other healthcare professionals to discuss test results and provide clinical insights.
• Stay up-to-date with the latest advances in the field through ongoing education, training, and professional development.
• Regularly calibrate and maintain laboratory equipment to ensure accuracy and reliability.
• Monitor and manage inventory of reagents, supplies, and consumables to ensure uninterrupted testing operations.
• Identify and resolve technical issues or anomalies in test results, and take corrective actions as needed.

• Training required for the role, may include ISMS, GLP, DocuSign and GDPR awareness.
• Appropriately deal with unexpected situations, incidents etc. and plan follow-up actions
• Undertake any other duties as required and appropriate to the nature and grade of the post.

Required Skills and Experience:

• Degree in biomedical science, biology, chemistry, or a related field.
• Currently HCPC registered as a Biomedical Scientist.
• Completed IBMS Higher Specialist Portfolio or Masters Degree
• Minimum of 3 years experience in Histology, Immunohistochemistry, Special stains, Embedding, Microtome, cutting sections.
• Ability to mentor and supervise junior members of staff, as well as assist in the management of the provision of a high quality laboratory service
• Proof of CPD and competency compliance
• Mandatory experience in preparation for UKAS audits and working in a UKAS accredited laboratory.
• Proficiency in a wide range of laboratory techniques, including microscopy, cell and various analytical and diagnostic methods.
• Awareness of clinical significance of laboratory finding and implications for patients
• Ability to provide technical and scientific advice as appropriate, and take further actions if test findings are anomalous or unexpected.
• Familiarity with and ability to operate, maintain, and troubleshoot laboratory equipment and instruments, including carrying out advanced troubleshooting in all laboratory sections.
• Strong data analysis skills, including the ability to use statistical software, data visualisation tools, and databases to interpret and report research or diagnostic findings.
• Knowledge of quality control and quality assurance principles, and the ability to implement and maintain quality control and quality assurance measures in the laboratory.
• Capability to develop, validate, and optimise laboratory methods and procedures.
• Proficiency in using computer software for data analysis, documentation, and laboratory information management.
• Understanding of bioinformatics tools and software for genomics, proteomics, and other data-driven research.
• Strong written and verbal communication skills to convey complex scientific concepts to colleagues, healthcare providers, and non-specialists.
• The ability to work effectively as part of a multidisciplinary team and collaborate with colleagues, physicians, and other healthcare professionals.

• Experience with GLP regulations or software will be ‘a distinct advantage’

Soft Skills

• Attention to Detail: Precision is essential in laboratory work, and a keen eye for detail is vital to ensure accuracy.
• Problem-Solving: Strong problem-solving skills to troubleshoot technical issues and anomalies in experimental or diagnostic results.
• Adaptability: The biomedical field is continually evolving, so adaptability to new techniques and technologies is crucial.
• Ethical Conduct: A strong commitment to ethical conduct, integrity, and patient data privacy is paramount.
• Analytical Thinking: The ability to analyze complex data and draw meaningful conclusions is essential for interpreting test results and conducting research.
• Time Management: Effective time management skills to handle multiple tasks and meet deadlines.

What are the benefits of working with Diagnexia?

• Competitive salary with performance based annual increments.
• Healthcare benefits
• Competitive annual leave
• A true sense of meaning in your work by contributing to better patient outcomes.
• The opportunity to work alongside a world-class high performing team in a hyper-growth startup environment.
• A chance to work on exciting,challenging and unique projects.
• Regular performance feedback and significant career growth opportunities.
• A highly collaborative and supportive multi cultural team.

Deciphex is an equal opportunities employer and we are committed to the principle of equality. All qualified applicants will be considered for employment without regard to age, race, religious beliefs, political views, gender identity, affectional or sexual orientation, national origin, family or marital status (including pregnancy), disability, membership of the travelling community or any other classification protected by applicable law.

Meridian Bioscience is a fully integrated life science company that develops, manufactures, markets and distributes a broad range of innovative diagnostic and life science products. We are dedicated to developing and delivering better solutions that give answers with speed, accuracy and simplicity that are redefining the possibilities of life from discovery to diagnosis. We are looking for talented and passionate individuals that help drive our vision. Our innovative culture will allow interested candidates to discover and create, through collaboration, cutting edge solutions to tough problems.

Job Summary:

Key Duties:

Tasks/Duties/Responsibilities:

• Identify and develop large volume opportunities, often with industrial customers or biotech/diagnostic SME.
• Develop opportunities in new areas, industry/biotechnology and institutes.
• Maintain current customer base.
• Meet monthly, quarterly and annual sales targets and goals.
• Identify new potential customers and all of the decision makers within the organization.
• Manage the sales CRM database.
• Report findings on sales trends and new developments
• Report findings on market conditions, successful strategies and competitive advantages
• Work closely with the sales director to identify a plan to achieve goals.
• Liaise with marketing to establish opportunities to enhance sales growth.
• Be a mentor and coach for other members of the team.
• Work alongside the product management team to assist in technical queries and to also establish areas, where we may partner our customers by providing technical presentations and seminars.
• Represent Meridian Life Sciences at local, national and occasionally international scientific meetings.
• Work with various procurement channels/administration systems to best present commercial offers
• Build relationships with KOL in industry and biotech
• Must be able to lift 20 Kg.
• Must be able to go up and down multiple flights of stairs each day.
• Be able to sit in front of a computer for multiple hours a day.
• Must be able to stand for long times throughout the day.

Qualifications:

• A relevant life sciences B.Sc. or higher that includes molecular biology or equivalent.
• 6+ years of direct sales experience in biotech field
• Knowledge of PCR and its applications
• Possess a full clean UK driving license
• Be a good communicator and must have an excellent telephone manner.
• Candidate must be tenacious in character and determined to succeed.
• Efficient in organizing visits, their time and good at planning.
• Be of an independent nature and have a strong will to succeed in what is a very competitive market.
• Work in a flexible manner
• Desire and motivation to sell.
• Self-motivated and capable of working efficiently in a small team and within the larger organization.
• Being able to develop strong customer relationships in different areas of the biological and medical research community