When our values align, there's no limit to what we can achieve.
At Parexel, we all share the same goal - to improve the world's health. From clinical trials to regulatory, consulting, and market access, every clinical development solution we provide is underpinned by something special - a deep conviction in what we do.
Each of us, no matter what we do at Parexel, contributes to the development of a therapy that ultimately will benefit a patient. We take our work personally, we do it with empathy and we're committed to making a difference.
Key Accountabilities:
General Accountabilities
• Provides clinical and scientific expertise to the clinical trial strategy and protocol development process, including acquisition of knowledge of competitor products.
• Designs/writes clinical trial outlines, protocols and amendments, in collaboration with internal contributors (e.g. statisticians, Outcomes Research (OR) specialists, clinical pharmacologists, clinical project managers, Regional Clinical Site Leads (RCSLs), market access colleagues, commercial development colleagues), internal experts (e.g. clinical program lead, global clinical lead, global clinical strategy lead), and external experts (e.g. investigators, key opinion leaders, advisory board members)
• Creates (and where appropriate, delivers) clinical/protocol training materials for study and site management and for use during site initiation visits and investigator meetings
.
• Helps establish and oversees Data Monitoring Committees (DMCs) and endpoint adjudication committees, including chartering, contracts, provision of relevant data and documentation of outcomes.
• Maintains direct contact with investigative sites through site visits, telephone contacts, email etc., in order to facilitate investigator engagement, address investigator questions regarding the protocol or the investigational product, and support enrolment activities. This is done in conjunction with RCSLs (when assigned) for sites outside US, Canada, Japan and China. For some studies the clinician may take on an expanded role as described below for the site liaison responsibilities.
Compliance with Parexel standards
Comply with required training curriculum.
Complete timesheets accurately as required.
Submit expense reports as required.
Update CV as required.
Maintain a working knowledge of and comply with Parexel processes, ICH-GCPs and other applicable requirements
Strong Communication Skills
Demonstrated project management / leadership experience
Skills:
• Experience in conduct and execution of clinical trials, including operational feasibility, recruitment, investigator performance, investigative site relations.
Knowledge and Experience:
• Preferred: Thorough understanding of local / international regulations applicable to clinical trials (pre and post approval). Practical experience in clinical trial strategies, methods and processes. Track record of design, oversight and interpretation of clinical studies. Previous leadership /management experience or training.
• Knowledge and experience in Good Clinical Practices.
• Fluent in both oral and written English.
• Fluent in host country language required.
Education:
• Preferred: M.D., Ph.D., D.V.M., M.S., and/or PharmD. or equivalent qualifications.