DOCS Global

Global Study Associate Manager

Location
UK
Salary
Competitive
Posted
13 Feb 2021
Closes
15 Mar 2021
Ref
26168
Hours
Full Time
Contract Type
Permanent
Experience Level
Experienced (non-manager)
The home-based Clinical Project Specialist (Global Study Associate Manager) is a member of the extended global study team supporting delivery of clinical studies to time, cost and quality, from Clinical Study Protocol development through study set-up, maintenance, close-out, development of Clinical Study Report to study archiving.

Typical Accountabilities;
*Leads/contributes to the preparation of delegated study documents (e.g. Informed Consent Form, master Clinical Study Agreement etc), and external service provider related documents (specifications, study specific procedures, descriptions, presentations etc.)
*Maintains and facilitates interactions with internal functions including but not limited to Enablement, Data Management, Procurement, Regulatory, Patient Safety and Quality Assurance, and external functions including the CROs and other external service providers to ensure an efficient study delivery to time, costs and quality objectives
*Ensures the supply of Investigational product and study materials by liaising with Clinical Supply Chain or external service providers as appropriate
*Ensures that all study documents in scope of Project Specialist responsibilities are complete and verified for quality in Trial Master File
*Supports Project Manager / Project Leader with budget management, such as external service provider invoice reconciliation
*Supports Project Manager / Project Leader in project management as per agreed delegation
*Ensures that all study documents in scope of Project Specialist responsibilities are complete and verified for quality in Trial Master File

Education, Qualifications, Skills and Experience
*University degree (or equivalent), preferably in medical or biological sciences or discipline associated with clinical research.
*Relevant experience from within the pharmaceutical industry or similar organization or academic experience, preferably of at least 3 years on similar position.
*Right-to-Work in the UK
*Experienced in supportive project management