Clinical Trial Manager

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