Regional Clinical Trial Manager

Location: Basel area
Length: 6 – 12-Months
Workload: 100%
Start Date: ASAP

We are supporting a global biotech organization in the search for an experienced Regional Clinical Trial Manager to support complex clinical development programs across multiple regions.
This is a hands-on role focused on driving regional trial execution, ensuring efficient site start up, and maintaining high quality standards throughout the study lifecycle. The position plays a key role in partnering with investigative sites and CROs, overseeing regional performance, and proactively identifying and mitigating operational risks.
You will work closely with global clinical teams, regional stakeholders, and external partners to ensure timely delivery of clinical trials, strong site engagement, and full compliance with regulatory and quality requirements.

Responsibilities

• Act as the regional lead within the Global Clinical Trial Team, ensuring representation of the assigned region (US/CA, EU, LATAM, or APAC) in trial strategy and execution
• Drive country and site level start up activities to ensure timely trial initiation and enrolment
• Review and support regulatory and ethics submissions including FDA, IRB/EC, CTA and ICF documents
• Serve as the primary point of contact for regional and country CRO teams
• Build strong partnerships with investigative sites and site staff to support trial delivery
• Monitor regional performance through KPIs and KRIs and drive actions where needed
• Identify, assess, and escalate protocol deviations, risks, and operational issues
• Support development and execution of risk mitigation and contingency plans
• Contribute to site selection, initiation, and monitoring activities
• Oversee CRO monitoring activities and ensure quality and compliance standards are met
• Participate in audits and support CAPA implementation
• Ensure sites are inspection ready in collaboration with QA
• Contribute to protocol development and informed consent review processes
• Mentor and support other Regional Clinical Trial Managers as needed

Requirements

• Bachelor’s degree in Life Sciences or related field
• Minimum 10 years of experience in pharmaceutical or biotech clinical development
• Strong experience managing regional and country level clinical trials across Phase I to IV
• Proven track record of CRO and vendor oversight
• Strong proficiency in GCP/ICH and regulatory issues is essential
• Experience with regulatory submissions and site start up processes
• Ability to manage trial metrics including KPIs and KRIs
• Experience identifying and managing protocol deviations and risk mitigation strategies
• Familiarity with audits, inspections, and CAPA processes
• Strong cross functional collaboration and stakeholder management skills
• Experience in rare disease trials is an advantage
• Willingness to travel up to 20%