Manager, Clinical Operations - FSP
TLDR
Leads global clinical trial operations, coordinating cross-functional teams and vendors to drive on-time, high-quality study delivery across regions.
- 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.
- 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.
- 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.
Requirements
Benefits
Benefits
Health Insurance
Comprehensive healthcare coverage, including medical, dental, and vision insurance.
Learning Budget
Career development, training, and leadership growth opportunities in clinical operations.
Paid Time Off
Paid time off, holidays, and additional flexible leave policies.
Remote-Friendly
Flexible work arrangements depending on study requirements and business needs.
Jobgether runs the largest remote job platform, effectively linking job seekers with over 200,000 flexible and remote opportunities that match their unique skills and preferences. Our focus is on enhancing the hiring process, ensuring efficiency while prioritizing the candidate experience, particularly in the growing health and wellness sector.
- Founded
- Founded 2020
- Employees
- 11-50 employees
- Industry
- Professional Services