Clinical Study Manager

Brentford, England (GBR)
£100 - £135 Per Day
12 Months
Start date: ASAP
Ref: GSKCSMGSH

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Skills

crf
sops
outsourcing
monitoring
budgets
operations management
management

Job description Posted 08 July 2020

Clinical Study Manager

Brentford

12 month Contract

£100 – 135 per day PAYE

Role description:

This role will be working with GSK on Phase I and IIa Global Health studies in tuberculosis, malaria and leishmaniasis. The successful candidate will be a team player with a focus on excellence and operational delivery. This Study Delivery Manager (SDM) role is within the Central Study Team (CST). Some flexibility is required to work with the wider global team in different time zones. The ability to work within a complex matrix environment is essential.

Activities may include (but is not limited to) the following:

• In house studies, multi-country early phase study management

• Accountable to ensure all relevant studies follow GSK SOPs and GCP.

• With direction, matrix with key study conduct partners.

• Assist with maintaining relationships and monitor performance of CRO's and other vendors.

• With direction from Senior Clinical Staff, collaborate with Clinical Operations functional groups (Regional Monitoring, Data Management, stats, clinical supplies and Operations Management) to ensure on time delivery of studies.

• Work closely with the LOC study managers and address any study related questions, address issues related to study drug supply.

• Manage sites/countries transitioning from study to commercial supplies.

• Manage study budgets

• Escalate issues as needed to the Study Delivery Lead/medical monitor.

• Provide input into identifying implications of study progress upon overall timeline goals conduct plans.

• With oversight manage study start-up, conduct and close-out.

• Assist in the management of CRO's or other outsourcing partners as appropriate.

• Provide input into content and execution of investigator meetings / may present selected topics.

• Provide input into development of CRF.

• Provide input into site selection with coordinated input.

• Aptitude for clinical systems, can do attitude, ability to work across projects/studies.

Additional information about the process

All profiles will be reviewed against the required skills and experience. Due to the high number of applications we will only be able to respond to successful applicants in the first instance. We thank you for your interest and the time taken to apply!

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