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.
We will offer a very market competitive compensation package which includes a Flexible Income Plan.
