- Select and manage CROs and sites, perform visits and training as required.
- Act as a primary point of contact for CROs and other External Service Providers (ESPs) for all clinical activities.
- Conduct and manage clinical trials from start up to close out: monitoring visits, recruitment and enrolment of patients, covering informed consent, eligibility and compliance with the protocol, study drug accountability, protocol deviations…
- Support CRA with queries generation and resolution, track and follow-up on serious adverse events, review eCRF, and maintain study files.
- Support ESPs with all queries related to sample lists, shipments.
- Ensure continuous update of Trial Master File in view of audits/inspections.
- Forecast drug supply needs in collaboration with Head of CMC.
- Participate in the development of the clinical study protocols and other study related documents in collaboration with other functions (e.g., ls, Investigator Brochures, clinical study reports, publications and internal /external presentations).
- Design, manage and track clinical trial timelines, risk and quality plans (single and multi-centered) and clinical trial budget.
- Communicate timely and accurately on operational clinical trial activities for internal reporting.
- Organize study-related meetings and training sessions.
- Organize scientific/medical reviews and evaluation of clinical trial data (e.g., IDSMB, Medical Advisory Boards), including the development of meeting agenda and minutes.
- Develop regulatory documents and responses to Health Authorities/Ethics in collaboration with other functions (e.g., CTA, IND, DSUR, Briefing Documents for advice meetings).
- Ensure quality, on-time delivery of all documents to meet submission targets to Health Authorities and Ethics.
- Communicate with regulatory authorities (e.g., document preparation, coordination of meeting rehearsals and minutes…) and with Ethics Committees as required.
- Review all QC/QA relevant issues and support internal and external audits.
- Support development of internal clinical-related SOPs as required.
EXPERIENCE AND QUALIFICATIONS
- MS or higher degree in Life Sciences with at least 5 years of experience in clinical trial operations (in a service provider or pharma/biotech company).
- In depth knowledge of ICH-GCP guidelines and GLP regulations.
- Hands-on experience in planing clinical trials, and managing all the operational aspects, and developing all study-related documents on-time, within budget and of high quality.
- Proven active involvement in the management of clinical Site and third-party vendors (CROs).
- Proactively identifies deficiencies and new risks in trial conduct, suggests corrective / preventive actions and escalate internally, as required.
- Formulates critical decisions, suggests alternatives, and obtains internal approval.
- Work closely with the senior executive team in a collaborative and welcoming environment.
- Solution-driven personality with strong initiative and drive. Organized, rigorous and self-starter who can anticipate the company's needs.
- Able to define its own workflow & execute it independently, while handling multiple priorities.