Senior Clinical Study Lead
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.
- 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
ProClinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.