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Our client develops innovative therapeutic antibodies in immuno-oncology fighting cancer cells by reactivating the body's own defense mechanisms.
For the next possible date we are looking for a Clinical Study Manager to step in a permanent position.
Clinical Study Manager (f/m/d)
- Implement and execute to a high standard all aspects of assigned clinical studies from designing and planning through to conducting and reporting
- Oversee and manage the day-to-day clinical trial activities internally, as well as externally with the CRO, vendors and external partners to monitor progress, timelines, and budget, and ensure study execution is of high quality
- Lead clinical trial team meetings with the CRO/vendor, proactively identify and manage risks, and ensure study deliverables (timelines, milestones, etc.) are on track and of good quality
- Manage, oversee, and build effective relationships with external vendors (e.g. CROs and other third party vendors) to ensure adequate service provision in clinical trial execution; this includes the evaluation, auditing, comparison of cost proposals and final selection of service providers
- Oversee performance of CROs and other third-party vendors, to ensure compliance with the protocol and in accordance with scope of work and in accordance with corporate timelines; identify areas of concern and escalate as appropriate
- Oversee the management of clinical trial sites during the planning and execution of the trial: prepare training materials, train sites, ensure ongoing adherence to clinical study protocol and procedures, perform ongoing study staff training (e.g. site initiation visits, ongoing training)
- Identify potential sites and investigators, oversee site qualification to ensure suitability and readiness of investigators and trial sites
- Review clinical trial documents (e.g. protocols, amendments, protocol information sheet / informed consent forms, Investigator Brochures, DSURs, clinical study reports, publications) in collaboration with the medical monitor and other members of the clinical development team; and review/approve study related documents (e.g. eCRF, cohort management plans, and clinical monitoring plans)
- Manage own regulatory authority applications and oversee outsourced submissions to regulatory authorities as well as Ethics Committees; coordinate the preparation of CDAs and contracts for CROs, third party vendors and trial sites, including contract negotiations
- Develop supportive documents such as pharmacy manuals, lab manuals, study worksheets and/or other documents needed for trial execution, and coordinate input from team members
- Support budget planning and management of assigned clinical trial(s) and/or work packages
- Review and approve invoices from sites, CROs and other service providers for work completed and prepare accruals
- BS in life sciences or a healthcare related field, MS or Ph. D. is preferred
- Background and experience in oncology drug development and in the management of Phase 1 and Phase 2 studies is strongly preferred
- Minimum 3 years of experience in global clinical trial management/oversight
- Experience in cell therapy studies preferred
- Proven leadership and relationship management
- In depth experience with study planning, site feasibility, study conduct and close-out, database lock through generation of the clinical study report (CSR)
- Experience in CRO and third-party vendor oversight and management
- Deep knowledge of design, set-up and conduct of clinical studies
- Profound knowledge of GCP and international regulations governing the conduct of clinical trials
- Stakeholder / relationship management experience
- Excellent and effective communication (both written and oral) and presentation skills
- Fluent in English (written and oral)
Would you like to learn more about CTC and the opportunity outlined? Please, get in contact with us: you may either use the 'apply now' button, or write an email to us, or reach out to us on the phone.