Clinical Study Lead/Global Trial Manager - FSP - Remote
Parexel, Uxbridge, England, United Kingdom
Overview
Parexel is seeking an experienced Clinical Trial Manager to join one of our key sponsors in the UK as a Clinical Study Leader. In this role you are accountable for the support of global execution of assigned smaller or less complex clinical trials from study design, through execution, to study close out.
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.
* Supports 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
Qualifications
* Bachelor’s degree and minimum 6 years of relevant global trial management experience
* Technical proficiency in trial management systems and MS applications, including but not limited to Teams, MS Office, Project, CTMS, EDC, IWRS/IVRS
* Knowledge of ICH GCP and relevant regulatory guidelines/directives
* Demonstrated interpersonal & leadership skills
* Ability to understand and implement the strategic direction and guidance for respective clinical studies
* Effective communication skills via verbal, written and presentation abilities
Seniority level
* Mid-Senior level
Employment type
* Full-time
Job function
* Research, Analyst, and Information Technology
Industries
* Pharmaceutical Manufacturing
* Biotechnology Research
* Hospitals and Health Care
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