This position is listed on behalf of a partner company, who manages all applications and next steps. Our partner is looking for a Manager, Clinical Operations – FSP based in the United States.
In this role, you will lead and coordinate key clinical trial operational activities across global studies, ensuring efficient execution from start-up through study close-out. You will act as a central driver of cross-functional alignment, overseeing vendors, supporting study strategy, and ensuring that timelines, budgets, and quality standards are consistently met. The position plays a critical role in shaping operational delivery, contributing to feasibility planning, risk management, and country-level execution strategies. You will collaborate closely with internal stakeholders and external partners to ensure seamless study delivery across regions. This is a highly collaborative and impact-driven role within a global clinical research environment. It offers the opportunity to influence study performance while supporting the development of life-changing therapies.
Accountabilities
- Manage and coordinate clinical trial operational activities across assigned studies, ensuring alignment with timelines, budgets, and quality expectations.
- Oversee CROs and external vendors, including selection, setup, statement of work creation, and ongoing performance management.
- Contribute to trial-level operational strategy, including protocol planning, feasibility input, recruitment planning, and risk mitigation activities.
- Develop, review, and maintain key study documents such as country-specific informed consent forms (ICFs), operational plans, and training materials.
- Monitor study progress including enrollment, regulatory submissions, drug supply, and data flow, ensuring proactive issue resolution.
- Collaborate with cross-functional teams such as Regulatory, Data Management, Safety, Finance, Clinical Supply, and Medical Affairs to support study execution.
- Support budget development, forecasting, and financial tracking for assigned clinical studies.
- Ensure inspection readiness and contribute to risk identification and mitigation planning at the study level.
- Drive process improvement initiatives and contribute to operational excellence across clinical operations teams.
- Support onboarding and mentoring of new team members and contribute to knowledge sharing within the function.
Requirements
- Bachelor’s degree in Life Sciences, Pharmacy, Nursing, or a related scientific discipline.
- Minimum of 5+ years of clinical research experience within a CRO, biotech, or pharmaceutical environment.
- At least 2–3 years of experience leading aspects of global clinical trials.
- Strong understanding of Good Clinical Practice (GCP) and global clinical trial regulations.
- Proven experience working with CROs and managing vendor relationships in clinical study environments.
- Demonstrated ability to manage budgets, timelines, and operational deliverables across multiple studies.
- Experience with protocol development, informed consent forms (ICFs), CRFs, and clinical study reports (CSRs).
- Strong analytical, financial, and decision-making skills with the ability to resolve complex operational challenges.
- Excellent organizational skills with the ability to manage competing priorities in a fast-paced environment.
- Strong communication, leadership, and stakeholder management skills in global matrix environments.
- Proficiency in Microsoft Office tools, including Excel, Word, and PowerPoint.
- Ability to work independently while influencing cross-functional teams without direct authority.
- Willingness to travel approximately 10%, with flexibility based on business needs.
Benefits
- Competitive annual compensation aligned with experience, qualifications, and market benchmarks.
- Comprehensive healthcare coverage, including medical, dental, and vision insurance.
- Paid time off, holidays, and additional flexible leave policies.
- Retirement savings plans and financial wellbeing programs.
- Opportunity to contribute to global clinical trials with meaningful patient impact.
- Career development, training, and leadership growth opportunities in clinical operations.
- Exposure to cross-functional, global project environments and innovative clinical research practices.
- Flexible work arrangements depending on study requirements and business needs.
- Inclusive and collaborative work culture focused on continuous improvement and operational excellence.