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Site Management & Monitoring Cluster Director
The Cluster Director (CD) will lead the MEA Cluster in SM&M EMEA Region and act as line manager for the Country Heads in the SM&M MEA team. The CD MEA is accountable for clinical study strategy planning and execution and for delivery of allocated clinical studies according to agreed resources, timelines, budget and quality and in compliance with regulatory requirements and the companies procedural documents.
The CD MEA will create and drive a productive and motivational team climate within the organisation to achieve individual, team and organizational objectives. The CD will ensure appropriate resourcing and skills management.
The CD MEA will be also responsible for exploring and assessing business development potential in the Middle East and Africa for conducting clinical trials.
- Develop business plan for the clinical operations in MEA
- Identify risks and opportunities there and based on that propose and develop operational model.
- Build an extensive network with internal and external stakeholders
- Accountable for building a visionary and productive MEA Team.
- Drives, secures and monitors clinical study execution in MEA.
- Accountable for quality, reliability and productivity in accordance with global and SM&M EMEA objectives.
- Accountable for effective resource allocation to ensure proper delivery of allocated studies, including identification of any need for in/outsourcing to CRO.
- Accountable for assigned budget.
- Provide expertise and guidance to support direct reports with proactive problem/risk identification, solution building and issues resolution to facilitate achievement of objectives on time and to appropriate quality.
- Promote and encourage innovation and creativity by bringing suggestions/good examples to departmental leadership
- Act as main point of contact for SM&M MEA and CROs in outsourced studies
- Maintain a constructive and productive collaboration with MEA cluster, EMEA region and related global functions
- Ensure relevant education and training of staff
- Ensure compliance with Regulatory and Patient Safety regulations and processes
- Ensure well-functioning cooperation with regional MEA commercial LT team, Medical Affairs, Regulatory Affairs, Medical Evidence functions and other support functions (Finance, HR, Procurement and Compliance functions)
- University degree in related discipline, preferably in medical, biological, or health related sciences, or equivalent qualification.
- Minimum 5 years’ experience in the pharmaceutical industry whereof > 3 years within clinical operations.
- Preferably more than 3 years’ experience as line manager in the pharmaceutical industry and in an international and diverse environment.
- Comprehensive knowledge of the drug development process.
- Good understanding of various therapeutic areas.
- Good understanding and knowledge of relevant applicable regulations.
- Demonstrate and comply with high ethical standards.
- Ability to understand integrated worldwide and regional delivery needs.
- Very good knowledge of spoken and written English.
- Knowledge of Arabic language will be a strong advantage.
- Ability to travel internationally.