Global Studies Manager - dedicated to client office

Provides direction and leadership to one or more global Study Management Teams

(SMTs).

Contributes to the development and management of the study timelines, budget, risk

and quality plans.

Provides clinical operations expertise to ensure operational feasibility and delivery.

Oversees forecasting of clinical/non-clinical supplies.

Delivers the operational elements of the study plan.

Provides the day-to-day operational management of CROs and vendors to ensure

delivery against contracted scope of work.

Identifies areas of best practice and process improvements.

Ensures study adherence to ICH/GCP and SOPs.QualificationsLife sciences degree or nursing equivalent.

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 affiliate teams, working with vendors and/or CROs, drug

supply management and planning operational activities to achieve database lock.

Experience of project managing operational aspects of a clinical study including

development and management of timelines and budgets.

Good knowledge of ICH GCP

Proven ability to successfully achieve results within a multi-cultural and

geographically diverse team.

Experience of working as part of a large team and leading small study or functional

teams, with a proven ability to be an active member of the team and motivate and

lead a small team to deliver against commitments.

Well-developed written and verbal communication skills demonstrated by an ability

to present clear instruction/direction to teams at the same level in the organization and

influence at higher levels in the organization.

Strong attention to detail

Proficient computer skills.