Global Studies Manager (GSM)
- Company
- Achieva Group Ltd
- Location
- London
- Salary
- £380 - £420 per day
- Posted
- 27 Jan 2021
- Closes
- 26 Feb 2021
- Ref
- BH-25422
- Contact
- Sophie Fosh
- Hours
- Full Time
- Contract Type
- Contract
- Experience Level
- Management
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
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