Clinical Project Manager (IVD experience required)

The Clinical Project Manager (CPM) plans and manages overall clinical operations for assigned global clinical trials/projects as part of product development projects, for CE-IVD as well as US FDA and other global registrations. The CPM outlines the clinical evidence strategy, in collaboration with the multifunctional project teams.

The CPM serves as a core team member of the IVD development team, providing scientific expertise and leading the execution of clinical evidence studies to ensure on-time delivery of clinical development deliverables.  This includes timelines, budgets, resources, investigational sites, vendors and key project deliverables in compliance with SOPs, regulatory requirements and ICH/GCP guidelines and in alignment with Biocartis business strategies and goals.   

Accountabilities

Clinical Study Design and Planning

• Designs the clinical development strategy in conjunction with the multifunctional project team.
• Leads the creation of study design in accordance with applicable standards and guidelines.
• Prepares Clinical Performance Study Plans and Protocols, including setting high-level timelines and establishing study budgets.
• Collaborates with Regulatory Affairs to determine applicable regulatory requirements for clinical studies in specific countries.
• Works with the Biostatistician to define the study design and statistical analysis of clinical data. 
• Responsible for overall execution of the clinical study plan and coordinates study activities throughout study start-up, conduct and close-out.

• Provides clinical support to (clinical) feasibility studies.

  Site Management

• Collaborate with the project team and partners in determining a list of potential study sites.
• Coordinates and/or performs site screening activities and initiates site qualification.
• Ensures site compliance with clinical study protocol and ICH/GCP guidelines.
• Maintains accurate and timely sponsor/site correspondence and communication.

• Act as point of contact to external stakeholders (Pharma and other partners) to ensure alignment on all aspects of clinical study design and execution.

  Study Documentation and Data Management

• Responsible for data management-related documentation and Trial Master File (TMF) and Investigator Site File (ISF) development.
• Ensure data integrity through completeness and accuracy.

• Responds to audit and data queries.

  Ethics and Regulatory Compliance

• Coordinates IEC/IRB review and reviews informed consent forms (ICF) for prospective studies to ensure subjects have properly consented.
• Participates in preparation of the clinical sections of regulatory submission packages and assists in responding to regulatory requests.

Vendor and Budget Management

• Manages all aspects of contracted clinical service providers (CROs); acts as the primary point of contact for all contracted clinical service providers.

Cross-Functional and Project Team Activities

• Actively participates as a member of cross-functional project teams; ensures cohesion between analytical and clinical activities, lends support as needed across cross-functional validation activities.
• Prepares and presents project progress reports to keep management and team informed.
• Acquires understanding of the Idylla platform principles and hands-on knowledge/skills in performing assigned assays.

Profile requirements

• Advanced degree in a scientific field (Master or PhD preferred) or equivalent through experience and/or training.
• 2-5 years of relevant experience working in Clinical Operations in the pharmaceutical/biotech industry/ medical device and/or a CRO.
• Experience with trial master file organization, regulatory documents, inspection preparation/readiness (site and Sponsor) and all aspects of trial and vendor management perferred.
• High degree of competence in all aspects of a clinical research program is required.
• Experience in IVD (clinical) development and validation studies is required.
• Experience in Companion Diagnostics projects is an asset.
• Proven experience with KOL-, CRO- and international project management is required.
• Experience in organizing and executing clinical studies for regulatory submissions.
• Scientific and technology background in molecular diagnostics.
• Strong working knowledge of GCP and IHC guidelines.
• Excellent technical writing and good documentation skills.
• Experience in application of international regulatory and quality (ISO, FDA, CLSI); GLP and GMP working knowledge
• PC skills:
  • MS Office (Word, Excel, PowerPoint, Outlook)
  • eDC and eTMF systems is an asset
• Languages: Fluent in English, both written and spoken.

Our offering

We offer you an exciting job in a fast growing international and innovative environment where you can work with top entrepreneurs in the biotech industry. You can be part of a very dynamic, young and growing team. You will have freedom to shape your work and shape your job where you deem it necessary: we value your input.