Clinical Trial Manager/Sr Clinical Trial Manager in United States at Jobgether

Manage global Phase 1–3 oncology clinical trials in alignment with clinical development plans, ICH-GCP guidelines, and applicable FDA and international regulatory requirements.

Identify and recruit study sites globally, build relationships with investigators, and support site selection, qualification, and activation.

Develop requests for proposals (RFPs), participate in vendor selection, and assist with negotiating vendor contracts and clinical trial agreements.

Oversee CROs and other study vendors, including interactive response technology (IRT), laboratories, and central ECG and imaging providers.

Track trial progress, patient enrollment, clinical trial material inventory, biological samples, timelines, budgets, accruals, and financial projections.

Review monitoring visit reports for completeness and adherence to documentation requirements, and support study monitoring and quality oversight.

Coordinate the packaging, labeling, and distribution of clinical trial materials.

Contribute to the development and review of protocols, informed consent forms, IRB/EC submissions, clinical SOPs, and other essential trial documentation.

Prepare, review, and approve study materials, including case report forms (CRFs), patient diaries, drug accountability forms, investigator and study manuals, project plans, and monitoring reports.

Support electronic case report form design, IRT development, data cleaning, and the creation of appropriate data outputs.

Communicate study progress, risks, and operational updates to management and program teams.

Collaborate with cross-functional departments, including Finance and Research, to support broader development objectives.

Provide leadership, guidance, and mentorship to clinical team members, including Clinical Research Associates (CRAs).

Perform responsibilities in accordance with organizational policies, core values, and applicable regulatory requirements.

An undergraduate degree in life sciences or a related health profession, such as pharmacy, medicine, nursing, or allied health sciences, is preferred.

Clinical Trial Manager: At least 5 years of relevant oncology clinical operations experience within a pharmaceutical company or CRO, including trial set-up, monitoring, and close-out for US and international Phase 1–3 studies conducted before NDA submission.

Senior Clinical Trial Manager: At least 7 years of relevant oncology clinical operations experience, including trial set-up, monitoring, and close-out across US and international Phase 1–3 studies conducted before NDA submission.

Demonstrated ability to manage multiple clinical trials, projects, and competing priorities successfully.

Experience managing clinical study vendors, including CROs, IRT providers, laboratories, and central ECG and imaging vendors.

Practical knowledge of ICH-GCP guidelines and US and international clinical research regulations, with experience applying these requirements in trial operations.

Experience with electronic data capture (EDC) systems and clinical data management software.

Experience managing Clinical Research Associates and supporting clinical team development.

Proven ability to review and assess clinical monitoring trip reports.

Excellent written and verbal communication skills, strong organizational abilities, and effective collaboration skills.

Ability to work successfully with global, multidisciplinary teams in an entrepreneurial, fast-paced, and dynamic environment.

A proactive, self-directed approach, combined with intellectual curiosity, a strong learning orientation, and a commitment to science and patient outcomes.

Salary: Anticipated annual base salary range of $145,000–$190,000, depending on relevant experience, industry background, education, and other job-related factors.

Annual bonus: Eligibility for an annual bonus.

Equity compensation: Stock options granted at hire and annually.

Paid leave: Paid time off, holiday leave, and sick leave.

Healthcare coverage: Medical, dental, and vision plans.

Insurance: Short- and long-term disability, basic and voluntary life and accidental death and dismemberment (AD&D) coverage, critical illness coverage, and accident coverage.

Flexible spending accounts: FSA, HSA, and commuter spending accounts.

Additional support: Employee Assistance Program and pet insurance.

Retirement and savings: 401(k) plan with employer contribution and eligibility to participate in an Employee Stock Purchase Program.

Work environment: A casual, collaborative, and engaging workplace with the opportunity to contribute to meaningful advances in oncology research.