Senior Clinical Trial Lead

Parexel; United States; Remote; USD 120,000 - 180,000; Full time

Job summary

Parexel seeks a clinical development leader to contribute to strategic trial design, protocol development and site engagement across global programs. This role emphasizes collaboration with statisticians, clinical pharmacologists and site personnel to advance therapies.

You will maintain strong communication with investigators, help manage data monitoring considerations, and ensure adherence to ICH-GCP and Parexel standards.

Qualifications

• Fluent in both oral and written English.
• Fluent in host country language required.
• Thorough understanding of local/international regulations applicable to clinical trials.
• 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.

Responsibilities

• 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.

Skills

Project management / leadership

Job description

Parexel seeks a clinical development leader to contribute to strategic trial design, protocol development and site engagement across global programs. This role emphasizes collaboration with statisticians, clinical pharmacologists and site personnel to advance therapies.

You will maintain strong communication with investigators, help manage data monitoring considerations, and ensure adherence to ICH-GCP and Parexel standards.