Global Operations Study Leader (m/f)
Office based in NRW; AS-011929
+49 89 24 440 7115
Global Operations Study Leader (Project Manager)
Duties and responsibilities:
- Keeps Study Oversight throughout planning, conduct and close out of the trial ensuring all departmental and cross-departmental deliverables and tasks are delivered.
- Develops and manages study timelines involving relevant functional experts, manages study milestones and ensures accurate tracking.
- Maintains overall oversight on trial budget providing regular estimates and updates based on feedback of relevant functional experts.
- Ensures effective Communication with client local offices, CROs and assigned vendors and maintains oversight of performance, issues, and their resolution, identify systematic issues and coordinates any corrective action and ensures the completion and finalization of any corrective and preventive action plans resulting from audits and inspections.
- Provides the day-to-day management of CROs and other operational vendors to ensure delivery against contracted scope of work.
- Contributes to forecasting and management of clinical and non-clinical supplies.
- Accountable for overall TMF in the trial.
- Ensures study adherence to ICH/GCP and SOPs.
- Leads one or more clinical study teams
- Ensures together with the Line Managers that all study team members are aware of their accountabilities, responsibilities and deliverables and reminds the study team to show a proactive behavior considering support of the study team and sharing all relevant information with the study team.
- Chairs study team meetings, CRO Alignment and kick-off meetings in collaboration with Outsourcing &Vendor Relationship Manager.
- Coordinates organization of appropriate study specific training to study team members.
- Facilitates communication and ensures effective good working relationships among study team members.
- Report Study Progress on Milestones, timelines, budget, recruitment, risks, TMF, study plans.
- Escalate operational issues as appropriate including potential risks and contingencies/mitigations.
- Ensures Set up, Maintenance and Execution of Study specific Trial Management Plans including but not limited to Risk Management Plans, Communication Plans, Safety Plans, Tracking of Deliverables, Recruitment and Retention Plans, TMF plans, Monitoring Plans, etc. as deemed appropriate for a specific Clinical Study.
- Proven clinical development experience of the operational aspects of all stages of clinical studies preferably working in a global environment and/or including monitoring or leading teams, working with vendors and/or CROs, drug supply management and planning operational activities.
- At least 2 years of experience as CRA.
- At least 2 years of international study management and CRO management experience is desirable.
- Experience of project managing operational aspects of a clinical study including development of timelines, budgets and resource plans.
- Excellent knowledge of ICH GCP.
- Experience of leading a study team or functional teams, with a proven ability to be an active member of the team and motivate and lead a team to deliver against commitments.
- Well-developed written and verbal communication skills demonstrated by ability to present clear instruction/direction to teams at the same level in the organization and influence at higher levels in the organization
- Life science degree or nursing equivalent or substantial experience in a clinical research/a healthcare environment.