Achieva Group Ltd

Global Studies Manager (GSM)

£380 - £420 per day
27 Jan 2021
26 Feb 2021
Sophie Fosh
Full Time
Contract Type
Experience Level
Our global pharmaceutical client has a vacancy for a Global Studies Manager. 

Position Purpose:
Provides operational expertise and leadership to one or more cross-functional global Study Management Teams (SMTs)
 Ensures the timely and efficient delivery of all operational aspects of one or more studies through all phases (phase 1b-IV) and stages (start-up, conduct and close-down), in accordance with the appropriate quality standards including ICH/GCP and applicable regulations.

Job Description
 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

Skills & Knowledge:
 Experience
 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 organisation.
 Strong attention to detail
 Proficient computer skills