Senior Clinical Project Manager
Senior Clinical Project Manager
Generaal de Wittelaan 11B Mechelen Belgium
R&D – Validation
Biocartis is an innovative molecular diagnostics company committed to revolutionize molecular testing with its unique proprietary IdyllaTM platform. We provide next generation diagnostic solutions aimed at improving clinical practice for the benefit of patients, clinicians, payers and the healthcare industry, with a focus on oncology.
Biocartis’ proprietary molecular diagnostics (MDx) IdyllaTM platform is a fully automated sample-to-result, real-time PCR system that offers accurate, highly reliable molecular information from virtually any biological sample, in virtually any setting, allowing fast and effective treatment selection and treatment progress monitoring.
Biocartis employs over 450 people and is headquartered in Mechelen, Belgium.
Senior Clinical Project Manager
The Senior Clinical Project Manager (SR CPM) leads and manages overall clinical operations for multiple, complex global clinical trials/projects with a primary focus on CE-IVD, US FDA submissions and other global registrations.
The SR CPM develops and executes the clinical evidence strategy in collaboration with the cross-functional project teams. These should be in alignment with Strategic & CDx partnerships and Biocartis business strategies and goals.
He/she serves as a core team member of the IVD development team, providing scientific expertise to ensure on time delivery of clinical development deliverables in accordance with regulatory requirements and ICH/GCP guidelines. The Sr CPM establishes best practices, efficiency improvements, and transfer clinical development knowledge across project teams. The Sr CPM may also serve as mentor to other Clinical Project Managers and CRAs.
Responsible for the development and execution of the clinical evidence development strategy in conjunction with a cross-functional project team.
Prepares clinical study plans that meet product design goals, regulatory requirements, business needs according to Biocartis procedures.
Key point of contact to external stakeholders (i.e. Pharma & other partners) to ensure alignment on all aspects of clinical study strategy and execution.
Manage all aspects of contracted clinical service providers (i.e. CRO’s, etc.) and acts as the point of contact for all contracted clinical service providers.
Proposes and negotiates budgets for clinical studies and external resource services.
Works collaboratively with Biostatistician to write clinical protocols using novel and unique study designs and prepare statistical analysis of clinical data.
Ensures site compliance with clinical study protocol and ICH/GCP guidelines.
Leads or oversees the development of study-related documents, including informed consent documents, study manuals and plans, trial master files, case report form design, etc.
Complies with all policies, established procedures, and regulations related to clinical research.
Actively participates as a leading member of cross-functional project teams, ensures cohesion between clinical and other Biocartis functional and strategic partner activities.
Participates in assessing performance data generated by investigational sites. Ensures data integrity through completeness and accuracy.
Acquires thorough understanding of the Idylla platform principles and “hands-on” knowledge/skills in performing assigned assays.
Advises and provides clinical support to (clinical) feasibility studies.
Key clinical expert that responds to regulatory agencies’ queries regarding clinical design, audit and data.
Develops of the clinical sections of regulatory submissions packages and assists in responding to requests from the regulator regarding the clinical study.
Good understanding of the design and development process.
Facilitates clinical strategy updates and communication between R&D, Regulatory Affairs, Sales, Marketing, and Senior Management through regular team, joint product and Internal and External Steerco meetings.
Participates in the writing and management of Clinical SOPs, templates and work instructions.
Participates as validation sub-sphere representative in design review or other stakeholder meetings as needed.
Shares his/her expertise with others and is able to coach and mentor other members of the clinical team.
Advanced degree in a scientific field (Master or PhD preferred) or equivalent through experience;
Min. 5 years of relevant experience working in Clinical Affairs / Operations in the pharmaceutical / biotech / medical device / IVD diagnostic industry;
High degree of competence in all aspects of a clinical research program is required;
Strong practical knowledge of compliance and regulatory environments (US, EU and rest of world) is required;
Experience in Medical Device and Companion Diagnostics projects is an asset;
Proven experience with KOL-, CRO- and international project management is required;
Experience in IVD (clinical) development and validation studies is required;
Experience in organizing and executing clinical studies for regulatory submissions is required;
Scientific and technology background in molecular diagnostics;
Strong working knowledge of GCP and IHC guidelines;
Excellent technical writing and good documentation skills;
Affinity with clinical drug development is an asset;
Planning & organization - Team/project planning & stakeholder management, plans ahead, monitors results and adapts plans; Self-starter & significant degree of autonomy; Clear sense of urgency and able to manage multiple projects simultaneously;
Adaptability to change – Supporting & facilitating change: enables and shapes change, helps others to understand the need for change and adapt to it;
Resilience – Maintains self-control, direction and effectiveness in high-pressure situations; Able to work under pressure and have a flexible approach;
Communication & influencing – Communicates with influence: influences and convinces internal and external stakeholders; empathic listener; Well-developed verbal and written communication skills; Ability to influence others to achieve positive results and collaboration;
Strategic thinking - Understands and applies Biocartis vision and strategy and aligns actions with it;
Coaching & development - Provides constructive feedback, takes an exemplary role towards learning, guiding and mentoring colleagues;
Exhibits flexibility in working collaboratively across internal and external stakeholders;
Demonstrated business acumen with ability to balance the need for maintaining high scientific standards with business relevance and impact;
Legislation and regulation:
Experience in application of international regulatory and quality guidelines for clinical laboratory methods (ISO, FDA, CLSI,);
GLP and GMP working knowledge;
MS Office (Word, Excel, Powerpoint, Outlook);
EDC and eTMF systems is an asset;
Languages: fluent in English, both written and spoken.
We offer you a challenging job in an exciting environment, working for top entrepreneurs in the biotech industry. You can be part of a very dynamic, young and growing team in a highly innovative environment. You will have freedom to shape your work and shape your job. Your input is highly appreciated. Of course we offer you a fitting compensation package.
Interested? Please apply via HR@biocartis.com