Local Trial Manager
+32 497 71 58 10
Description de l'emploi
The Local Trial Manager (LTM) is responsible for local management of a clinical trial (or Medical Affairs data generation activity) in a country or countries. The LTM is the primary point of contact at a country level for assigned studies and has operational oversight of assigned protocol(s) from start-up through to database lock and closeout activities as described in GCO procedural documents. The LTM is responsible for coordinating and leading the local trial team to deliver quality data and trial documents/records that are compliant with the assigned clinical trial protocol, company Standard Operating Procedures (SOPs), Good Clinical Practice (GCP), and regulatory requirements.
The LTM actively contributes to process improvement; training and mentoring of Clinical Trial Assistants (CTA), Site Managers (SM) and other LTM roles. The LTM may have some site management responsibilities.
The LTM may also perform the role of Clinical Trial Manager (CTM)/Global Trial Lead (GTL) for single country as described in GCO procedural documents.
- A minimum of a BA or BS degree in Life Sciences, Nursing or related scientific field (or equivalent experience) is required.
- Minimum two to four years of pharmaceutical and/or clinical trial experience is preferred (including site monitoring experience), however other relevant experiences and skills may be considered by the hiring manager when considering the candidate’s eligibility.
- Specific therapeutic area experience may be required depending on the position. Should have solid understanding of the drug development process including GCP and local regulatory requirements. Willingness to travel with occasional overnight stay away from home.
- Solid leadership skills. Solid communication and computer skills required. Proficient in speaking and writing the country language and English language. Excellent written and oral communication skills
- Some experience in mentoring/coaching and providing training to other LTMs, SMs and CTAs preferred. The ability to lead initiative/small teams.
- Flexible mindset and ability to work in a fast-changing environment. Ability to work on multiple trials in parallel