Senior Clinical Trial Manager (897277-GBA)
- Experience Level
- Experienced (non-manager)
Our client, an exciting and growing clinical stage biotechnology company with clinical studies across multiple therapeutic areas, is looking for a Senior Clinical Trial Manager to be permanently employed in the Zug area.
If you have 8 years of experience managing regional and/or global studies from study start-up to closeout in a pharmaceutical/biotech company, strong CRO selection and management expertise, and exceptional project management skills, then look no further and apply! Prior experience within the Autoimmune space would be advantageous.
- Leads the clinical operations team (CRAs and CTAs) and cross-functional clinical trial team in the planning, execution and reporting of clinical trials, ensuring alignment of activities with study timelines, budgets, SOPs, GCP and applicable regulatory guidelines;
- Responsible for clinical trial material (CTM) label review and approval and assisting with CTM forecasting;
- Proactively identifies and resolves operational issues/processes to ensure achievement of study milestones, data quality and data integrity; escalates study-related issues appropriately in a timely manner;
- Obtain and relay key study issues, status updates and other study information to the clinical trial team and management;
- Manages recruitment efforts and activities to meet study enrollment goals and timelines, and provides status to upper management;
- Interacts with other functional areas and key stakeholders, including Clinical Development, Data Management, Finance, Regulatory, Quality Assurance, Safety, Clinical Supply (Investigational Product) and clinical vendors (e.g., central laboratory, CROs), as needed, to support clinical trial activities;
- Participates in the identification and selection process for CROs and vendors;
- Provides input on protocol design and statistical analysis plan (SAP);
- Provides input on the development of eCRF design;
- Participates in IRT, EDC and ePRO user acceptance testing;
- Participates in protocol deviation listing reviews and meetings;
- Responsible for oversight of study budget, investigator and vendor contracts, budgets and payments;
- Provides input/reviews DSUR, PSUR and regulatory annual and periodical reports.
Qualifications and Experience:
- Valid Swiss working/residency permit and/or Swiss/EU-Citizenship required;
- Bachelor’s degree, ideally in a scientific field;
- 8+ years of relevant and progressive clinical trial management experience working on regional and/or global trials, within a pharmaceutical/biotech company;
- Experience in full-cycle drug development;
- Strong understanding of clinical trials processes, protocols and medical terminology;
- Strong experience utilizing CTMS, EDC, TMS and related software;
- Prior experience in management and monitoring of CRO and investigative sites;
- Strong experience with patient recruitment, non-compliance, safety, document management, investigational product, IP accountability, and budget management;
- Broad knowledge of ICH, GCP, IRB/IEC and local regulatory authority drug research & development regulations;
- Advanced experience with bio-samples, storage of 3rd party data;
- Motivated to work in a fast-paced, high accountability environment;
- Travel up to 25%;
- Fluency in English. Additional languages a plus.