Global Clinical Trial Leader

Job Description

Job Description

Job Overview:

Pay Range: $100.07hr - $105.07hr

Requirement/Must Have:

• 8+ years of clinical study management experience desired.
• Working knowledge of GCP/ICH requirements, international regulatory guidelines, and the end to end drug development process.
• Proven experience managing delegated aspects of global, complex Phase I and II clinical studies.
• Demonstrated success effectively managing a diverse portfolio of vendors and CROs.
• Adept at identifying, assessing, and proactively mitigating operational risks using quantitative and qualitative data.
• Some travel may be required.

Responsibilities:

• Accountable for the execution and delivery of early development global clinical trials under the leadership of the Sr. CTL.
• Implement novel and highly flexible global operational strategies for complex programs focusing on new molecular entities.
• Provide operational guidance to one or more global cross-functional Protocol Execution Teams (PETs) across all study stages including start-up, conduct, and close-out.
• Foster a positive work environment built on mutual respect, innovation, and accountability at both local and global project levels.
• Drive and finalize cross-functional activities ensuring the quality delivery of vendor specifications, drug supply forecasting, monitoring/communication plans, Trial Master Files (TMF), and CTMS data.
• Collaborate with cross-functional members on study plans and coordinate effective investigator meetings.
• Participate in vendor selection and oversee outsourced activities to ensure CROs and vendors deliver strictly against contracted scopes of work.
• Provide strategic input into the overall study budget and directly manage assigned vendor budgets.
• Contribute to country and site selection, assist in developing clinical trial protocols/informed consents, and provide operational input on protocol feasibility.
• Apply critical thinking to manage timelines, identify bottlenecks, and propose actionable resolutions.
• Maintain a patient and site-centric mindset across all trial activities and interactions.
• Partner with colleagues to establish operational best practices and enhance clinical trial execution across the organization.
• Serve as a Subject Matter Expert (SME) or single point of contact for targeted functional initiatives.
• Coach, mentor, and share expertise to support the development of junior staff and peers.

Skills:

• GCP/ICH requirements.
• Clinical study management.
• Vendor management.
• Risk mitigation.
• Drug supply forecasting.
• Trial Master Files (TMF).
• CTMS data.
• Protocol feasibility.
• Strong verbal and written communication skills.
• Excellent communication and presentation skills.
• Problem solving.
• Stakeholder management.

Qualification And Education:

• Bachelor's degree or equivalent required (scientific or healthcare discipline preferred).

Benefits:

Our Benefits Include:

• Medical, Dental, and Vision Insurance
• 401(k) Retirement Plan
• Health Savings Account (HSA)
• Disability Insurance (Short-Term and Long-Term)
• Life and AD&D Insurance
• Paid Sick Leave (where required by applicable state or local law)
• Supplemental Insurance Plans
• Identity Theft Protection
• Pet Insurance
• Employee Wellness Programs
• Employee Assistance Program (EAP)
• Career Growth and Professional Development Opportunities

Disclaimer : Benefits eligibility, accrual rates, and usage limits may vary based on employment status, length of service, and work location. Paid Sick Leave is provided in strict accordance with applicable state and municipal mandates. Cynet Systems Inc. reserves the right to modify, amend, or terminate any benefit plans at any time in accordance with applicable laws.

About Cynet Systems

Founded in 2010 and headquartered in the Washington, DC metro area, Cynet Systems Inc. is a leading technology staffing and workforce solutions company serving Fortune 500 companies, government agencies, and enterprise organizations across the United States and Canada. We deliver agile, scalable talent solutions across IT, engineering, life sciences, clinical, and professional staffing, powered by a high-performing recruitment engine operating across North America and Asia.

As a nationally and locally certified Minority Business Enterprise (MBE), Cynet Systems is committed to helping organizations build high-performing teams while empowering professionals to grow rewarding careers. Our organization is certified to ISO 9001, ISO 14001, ISO 27001, and SOC 2 Type II standards, reflecting our commitment to quality, security, operational excellence, and customer success.