Senior Clinical Study Lead job in 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?*

Message

First Name*

Last Name*

Email*

Phone Number*

Country*

Are you an employer or a jobseeker?*

Message

Job type: Permanent

Discipline: Project/Study Manager (CSM/CPM)

Location: United Kingdom

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

An exciting opportunity has arisen for a Senior Clinical Study Lead to join a leading biopharmaceutical company. This organisation focuses on the treatment of serious medical conditions and are looking for someone to be accountable for all Clinical Study Operations, ensuring effective results.

Job Responsibilities

Leads the cross-functional study team responsible for clinical study delivery and is the primary point of contact of leadership and oversight (as required) for the assigned study
Provides operational input into protocol development
Oversees and provides input to the development of study specific documentation including but not limited to: case report forms (CRF), data management plan, monitoring plan, monitoring oversight plan, project specific training plan, data review plan, statistical analysis plan, etc.
Oversees set-up and maintenance of study systems including but not limited to Clinical Trial Management System (CTMS), Trial Master File (TMF) etc.
Ensures compliance with the clinical trial registry requirements
Identifies outsourcing needs of the study and leads and oversees engagement, contracting and management of required vendors
Provides input into baseline budget development and management
Provides input into baseline timeline development and management
Leads risk assessment and identifies risk mitigation strategies at the study level
Leads the feasibility assessment to select relevant regions and countries for the study
Oversees/conducts site evaluation and selection
Leads investigator meeting preparation and execution
Monitors progress for site activation and monitoring visits and acts on any deviations from plan
Leads the development of and oversees implementation of patient recruitment and retention strategies and acts on any deviations from plan

Skills and Requirements

Bachelor's degree and minimum of 8 years relevant industry experience. Advanced degrees may be considered in lieu of relevant experience.
Demonstrated interpersonal & leadership skills
Ability to understand and implement the strategic direction and guidance for respective clinical studies
A data driven approach to planning, executing, and problem solving
Effective communication skills via verbal, written and presentation abilities
Ability to influence and negotiate
Demonstrated vendor management experience

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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