- Supports development of the Evidence Generation studies/programs: under the direction of the Medical Director/Medical Manager and in collaboration with the Medical Science Liaisons, in alignment with brand strategies:
- Participates in strategy development on means to generate evidence (clinical trial or real-world evidence) in alignment with brand strategies, including but not limited to Healthcare Database exploration, partnerships with investigators, academic centers and vendors/CROs.
- Assist in the development of clinical programs materials as needed (protocol, CRF, ICF, data management plan, etc).
- Leads the clinical data management activities part of the evidence generation program.
- Ensure excellence in study/program start-up: manages the approval process of all studies conducted locally: investigators initiated studies, local data generation studies and global clinical research programs.
- Evidence Generation Management and Monitoring: monitors ongoing studies and collects and reviews related data to ensure contract compliance and resolves routine monitoring issues. Ensures key cross-functional team members (medical affairs, market access, commercial) are informed of significant operational issues that impact study objectives.
- Manages contracts and budgets with clinical trial service providers, clinical research organizations, and consultants preparing clinical trial documents (e.g. protocols, legal contracts, site operations manuals) and ensures that these activities are conducted in accordance with contract agreements, regulatory requirements and Takeda standards and policies. Reports budget updates to internal budget owners.
- Develops and maintains operational procedures and standards in collaboration with other Departments of Takeda Belgium (e.g. QA and Regulatory Affairs) and aligned with global policies and guidelines.
- Therapeutic area exposure but not limited to: Oncology (Multiple Myeloma, Lymphoma & Lung Cancer) & Gastroenterology (Inflammatory Bowel Disease)
- Demonstrated understanding of evidence generation strategies and data management principles
- Demonstrated understanding of brand planning process
- Demonstrated working knowledge of clinical trial development and knowledge of operational and regulatory processes involved in Phase IIIB/IV trials and real-world evidence studies.
- Demonstrated experience in supplier management including supplier evaluation, contract content and budget management, interfacing with suppliers to manage resolution of issues
- Demonstrated technical competence in design, implementation, tracking and completion of clinical trials pre and post commercializationBusiness Knowledge
- Demonstrated knowledge of financial principles in budgeting and tracking of clinical trials
- Demonstrated written and oral communication and organizational/time management skills
- Product knowledge in order to exchange information and communicate with external organizations such as CRO’s, consultants and vendors
- Takeda’s policies and standard operating procedures to ensure their proper application to the position’s dutiesEDUCATION, LICENSES/CERTIFICATIONS, EXPERIENCE:
- Minimum Bachelor Degree in science related field, Preference for MSc or Doctorate degree (PhD PharmD, MD)
- 5-8 years clinical trial/data management experience, with some experience in clinical study design and operations management in pharmaceutical industry or related health care industry with experience in evidence generation (real-world evidence and clinical studies)Travel requirementrsWillingness to travel to various meetings or client sites. Some international travel, including overnight trips may be required.