Clinical Trial Manager m/f/d, Basel-Stadt The Clinical Trial Manager serves as their region's lead and expert on complex clinical development trials to secure expeditious country level set-up, start, enrolment and quality control
Contract duration: until 31.12.2026 (possible extension)
Location: Basel (on-site)
Travel: Up to 20%
Responsibilities: - Serves as a core member of the Global Clinical Trial Team and secure that the region US/CA, EU, LatAm and/or AsiaPac (to which they cover) perspective is considered in relevant aspects of the global set-up and management of the trial(s).
- Contributes to the review of key regional documents (e.g. FDA/IRB, CTA/EC or other regulatory submission packages, country/site ICF, and others) to support expeditious operational site set-up.
- Reviews EC/IRB submission responses and facilitate quick feedback.
- Works with the Regional/Country CRO team and acts as their primary point of contact.
- Key partner to the trial sites, particularly with the Clinical Research Coordinator staff (e.g. study coordinators/nurses, pharmacists, contracts managers, nutritionists, etc)
- Supports in set-up and monitoring of Regional/Country site milestones and metrics including Key Performance Indicators (KPIs) and Key Risk Indicators (KRIs)
- Upon request from gCTM, can coordinate a team of rCTMs in review of Regional/Country site milestones and metrics
- Actively monitors protocol deviations of Regional/Country sites and addresses/escalates potential risks and issues.
- Upon request from gCTM and in alignment with study Medical Lead, can coordinate a team of rCTMs in monitoring and assessment of protocol deviations to address/escalate potential risks and issues
- Collaborates and drives team to develop and implement contingencies for risk mitigation.
- Identifies opportunities to accelerate trial start-up activities within the region and collaborates with the team on developing actions around these opportunities.
- Participates in Site Selection Visits and leads assessment, securing input from other relevant functions as needed.
- Participates in Site Initiation Visits and monitoring visits (as needed).
- Performs monitoring oversight visits with CRO monitors to ensure study personnel are appropriate
- Participates in site audits when required and aids in CAPA implementation
- Works with sites and QA to ensure clinical trial sites are inspection ready
- Participates in protocol development and master/local ICF process (reviewer)
Experience: - Bachelor's degree with 10 years of pharmaceutical/Biotech clinical development experience.
- The ideal candidate has very broad experience in Regional level clinical trial management
- Must have significant experience managing regional/country aspects of activities in Phase I-IV trials, oversight of CROs and vendors.
- Advantageous to have rare disease trial experience.
- Proven ability to effectively collaborate with a large group of interdisciplinary teams and Vendors
- Strong proficiency in GCP/ICH and regulatory issues is essential
- Up to 20% travel may be required
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coopers.chJob Profil (4U90EZ) - Life Sciences - Clinical & Safety
- Basel-Stadt
- Contracting
- Vollzeit
- Immediately - 31.12.2026
- clinical trials, Clinical Operations, Orphan drugs
Klingt interessant?
Einfach "Jetzt bewerben" klicken, dann melde ich mich. Agnieszka Kawalec
Talent Acquisition Consultant
+41 41 632 43 54 agnieszka.kawalec@coopers.ch
