Main Responsibilities:
1. Planning, set-up, conduct and closeout of trials (phase 1 to phase 3)
2. Planning set-up, conduct and closeout of an Expanded Access Program
3. Accountable for operational leadership and delivery; Cooperates with relevant functions to deliver the trial within timelines, budget and with high quality
4. Prepares trial budgets, forecasts, timelines, and project plans
5. Contributes to requests for proposal; Negotiates contracts and budgets for assigned projects
6. Ensures close CRO surveillance and management of other third-party vendors (central labs, IWRS, clinical supply distributors, etc.)
7. Provides input to clinical study protocols, investigator’s brochure, informed consent sheet, etc.
8. Prepares trial related documents (manuals, guidelines, visit reports, newsletters); reviews and contributes to study
9. Performs UATs for systems implemented on a trial
10. Plans and leads or participates in project meetings, training workshops and investigators meetings
11. Supervises training of cross-functional study team members to assure consistency and compliance in conduct and monitoring of clinical trials
12. Prepares and distributes regular and ad hoc reports, summaries, or analyses as required; Prepares status reports for assigned clinical trials
13. Conducts co-monitoring and oversight visits
14. Participates in internal/external audits
15. Ensures TMF/eTMF is set-up adequately, checked on a regular basis and kept up to date
16. Ensures inspection readiness
Qualifications and Experience:
17. Relevant working/residency permit or Swiss/EU-Citizenship required.
18. At least 5 years’ experience in managing clinical trials phase 1 – 3, preferably from CRA level up to global clinical trial manager
19. Solid understanding of clinical trial systems (EDC, IRT, eTMF, CTMS, etc)
20. Robust knowledge of ICH-GCP and clinical trial regulations in multiple countries Previous involvement in internal audits and regulatory authority inspections is a plus
21. Effective communication, organizational, problem solving and time management skills
22. Proficient In English