Global Clinical Study Manager job in London, England

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First Name*

Last Name*

Email*

Phone Number*

Country*

Are you an employer or a jobseeker?*

Message

First Name*

Last Name*

Email*

Phone Number*

Country*

Are you an employer or a jobseeker?*

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Job type: Contract

Discipline: Clinical Scientist

Location: United Kingdom

This vacancy has now expired. Please see similar roles below...

A vacancy has become available for a Global Clinical Study Manager, this is a home-based role at a large pharmaceutical organisation. You will be expected to work cross functionally to ensure study delivery.

Job Responsibilities

In partnership with internal experts and external service providers, provide oversight to ensure study delivery of both internally-run and outsourced studies.
Lead/contribute to the preparation of delegated study documents (e.g. Informed Consent Form, applicable study plans, etc.), and external service provider-related documents (e.g. specifications, study specific procedures, etc.)
Maintain and facilitate interactions with both internal & external functions to ensure efficient study delivery to time, costs and quality objectives.
Manage the set-up and maintenance of third-party vendors.
Support the SrGSL/GSL with budget management. Initiate contract/budget requests for third-party vendors, facilitate generation of purchase orders, track spend against approved budget and manage the change order process.
Provide input to data management documents (e.g. Case Report Form, Data Validation Specifications), and interface with data management representatives and sites to facilitate the delivery of study data.
Contribute to the planning and conduct of internal and external meetings.
Ensure adequate supply of study materials by liaising with Clinical Supply Chain or external service providers as appropriate.
Proactively contribute to risk and issue identification, development of mitigation and/or action plans for identified risks and issues.
Ensure that all study documents within scope of the GSM's responsibilities are complete and verified for quality in the Trial Master File (TMF).
Take on assignments on non-drug project work in process improvements and/or leading improvement projects as discussed and agreed upon with their line manager. May act as Subject Matter Expert for a particular process or system within Study Management Early.

Skills and Requirements

University degree (or equivalent educational/work experience), preferably in medical or biological sciences or discipline associated with clinical research.
Relevant pharmaceutical industry and/or clinical trial experience.
Deep understanding of ICH-GCP, relevant regulatory/ethics requirements and clinical/drug development.
Proven organisational, time management & analytical skills; excellent attention to detail and ability to multi-task in a fast-paced and dynamic environment
Demonstrated ability to work well both on a cross-functional team and independently
Strong collaborative communication skills (verbal & written) in English
Ability to prioritise appropriately and to be adaptable
Demonstrated leadership skills
Computer proficiency in day-to-day tasks

To Apply

Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.

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