Associate Director Study Management

A leading global pharmaceutical company are looking for an Associate Director Study Management to join their early clinical development team based in Cambridge (Melbour Science Park). Experience in phase I oncology trials is an essential for this role.

The Associate Director Study Management is accountable for assisting Director(s) Scientific Project Management fulfil their accountabilities through planning and leading the delivery of all components of the company sponsored and clinical study (or group of clinical studies) to time, cost, and quality from study design through study closeout activities.

Accountabilities:

- Plan and Lead the delivery and reporting of all components of the sponsored ECD led clinical study (ies) to time, quality, budget, project standards, company quality standards, and scientific requirements
- Leader of the study delivery team for the sponsored ECD led clinical studies
- Liaise with the Clinical Operations group to identify and resolve operational feasibility issues, and facilitate study start-up activities
- Forecasting and day-to-day management of study timelines, budget, materials and development of detailed study level plans and feasibility assessment
- Lead preparation and delivery of study documents (eg Protocols/amendments, documents detailing study delivery data management activities, etc.)
- Track and manage to agreed study timelines, budget, and resource and ensure the update of appropriate systems (eg IMPACT, OPAL, )
- Plan, lead and ensure appropriate training is achieved at Investigator/monitor meetings

EXPERIENCE:

- University degree in related discipline, preferably in medical or biological science, or discipline associated with Clinical Research or equivalent in experience
- Extensive experience in leading studies/programmes in early clinical development
- Extensive experience in phase I oncology studies is a requirement
- Experience of working with and delivering through strategic partners and 3rd party vendors
- Proven leadership experience (people and project)
- Project Management experience within the context of Clinical Drug Development

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