Clinical Trials Project Leader
il y a 3 semaines
Key Responsibilities:
- Oversee and manage the execution of one or multiple clinical studies.
- Ensure that the project is always prepared for audits (including project team training documentation, central files, system validation, etc.).
- Administer the project(s) within the established budgets and timelines.
- Take charge of the selection, contracting, coordination, and oversight of CROs and service providers engaged for specific projects.
- Accountable for drafting and/or supervising the CROs in the creation of clinical project outputs such as study manuals, operational plans, and study tools.
- Contribute to the writing of clinical project outputs including protocols, study reports, and case report forms (CRFs).
- Compile investigational site lists and engage in the review and approval of investigational sites.
- Prepare and deliver updates on the status of clinical projects to Clinical Management.
- Monitor individual clinical trials to ensure that safety issues and/or adverse events are recognized and that appropriate actions are developed and implemented.
- Responsible for corrective action strategies at individual sites and across the trial. May engage in internal/external trial-related audits.
- Reports to the Manager of Clinical Operations – International.
Qualifications:
- Master's degree in Life Sciences or a related discipline.
- A minimum of 5 years of experience in the clinical research sector.
- 2-3 years of experience as a clinical project manager within the medical devices/pharmaceutical industry, in a CRO, or with an institutional sponsor.
- Proficient in building strong interpersonal relationships with healthcare professionals.
- Exceptional verbal and written communication skills in English, along with strong presentation abilities.
- Proficiency in a second language is advantageous (Spanish, German, or Italian).
- Familiarity with the laws, regulations, standards, and guidelines governing clinical study conduct.
- Capable of independently managing and reporting trial status to the project team.
- Strong project management and planning skills.
- Willingness and availability to travel within Europe.
Work Location: Remote/Home based opportunities available.
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