Interim Clinical Trial Manager III
Short notice availability
Work in Zurich City
About Our Client
Our client is a global pharmaceutical organization based in Zurich
- Customize/update any portfolio/ study-specific plans and process flows for multiple clinical vendors, as appropriate e.g., TMF Plan, site training plan, site monitoring plan, cross functional data review plan, IP release plan etc.
- Contribute to Center for Excellence initiatives to drive continuous improvement and delivery of business technologies that are operational in a study/program/franchise.
- Ensure study document submission to the TMF throughout the study's life cycle.
- Assist CPL by tracking compliance to all study level plans and escalating any variances.
- Cross franchise business technology expert participating in system selection and implementation of business technologies used during the study (e.g., EDC, Investigator Portal, TMF).
- Ensure CRA compliance with the study parameters via review of monitoring visit reports.
- Track escalation and closure of action items noted in the monitoring visit reports.
- Ensure registration of a protocol in ClinTrials.gov/EUdract and monitor its update throughout a study's life cycle for compliance with the regulations and SOP.
- Assist CPL with Interactions with CRO and site staff to adhere to study budgets.
- Requests accruals, and performs contract and invoice review.
- Participate in operation meetings with CRO, and cross-functional team members; document escalations and actions.
- Coordinate study team training in the investigator portal; monitor site/CRA user access and track.
- Coordinate with CPL and cross-functional team to assemble study documents as appendices for
CSR at study close-out.
- Upon site closure, prepares subject files, inventories documents, reconciles document
discrepancies, and organizes study files for electronic archive and off-site storage.
- SME for initiatives in conjunction with the CoE, as required to ensure consistent implementation
of best practices across all studies and franchises.
The Successful Applicant
- 4+ years of clinical research experience, in the pharmaceutical industry with a solid understanding of technology and processes used in drug development.required.
- Work with CROs and vendors to drive timelines and deliverables.
- Demonstrated leadership skills to manage/mentor junior staff and prioritize multiple tasks effectively or work independently if required.
- Bachelor's degree or equivalent in one of the disciplines related to clinical practice/health care,
life sciences, or drug development, Research certification desirable.
What's on Offer
Be part of a growing international pharmaceutical organization.