Senior Clinical Study Lead

Highly Competitive
  1. Permanent
  2. Project/Study Manager (CSM/CPM)
  3. United Kingdom
Posting date: 18 Jan 2021

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.