Manager, FSP Clinical Operations

May 2, 2026

When our values align, there's no limit to what we can achieve. At Parexel, we all share the same goal - to improve the world's health. From clinical trials to regulatory, consulting, and market access, every clinical development solution we provide is underpinned by something special - a deep conviction in what we do.Each of us, no matter what we do at Parexel, contributes to the development of a therapy that ultimately will benefit a patient. We take our work personally, we do it with empathy and we're committed to making a difference.Key Accountabilities: Program Management <ul><li>May serve as a central Point of Contact (POC) between Senior Management and key Client personnel for contracted FSP Clinical Operations activities </li></ul><ul><li> May serve as a liaison to one or more Clients </li></ul><ul><li>May be responsible for Program Management activities related to one or more programs: </li></ul><ul><li>Oversees implementation, management, and closeout of Client programs, as required </li></ul><ul><li>Develops interview tools and conduct interviews with potential candidates based on Client requirements and selects staff for hire (with/without Client input) o Evaluates and deploys resources based on Client need, experience, and availability (workload capacity management, contingency planning), and manages/analyzes resource utilization to ensure cost effectiveness </li></ul><ul><li>Leads/contributes to Client-specific Operations meetings with Operations internal staff </li></ul><ul><li>Manages program issues, including problem identification, resolution, and escalation, as appropriate to FSP Clinical Operations and Client </li></ul><ul><li>Proactively manages program-level expectations, Key Performance Indicators (KPIs), and metrics </li></ul><ul><li>Oversees program transitions to ensure proper training, adequate project support, and to ensure the resource is aware of program expectations </li></ul><ul><li>Utilizes tools and systems to proactively collect, track, and analyze compliance/performance metrics </li></ul><ul><li>Adheres to quality standards and timelines within assigned areas in compliance with local regulations (i.e., FDA, EMA, etc.), ICH/GCPs, and SOPs </li></ul> Line Management <ul><li>Manages FSP Clinical Operations assigned staff dependent upon Client structure and services </li></ul><ul><li>Oversees/Manages personnel and administrative issues for assigned FSP Clinical Operations staff (direct reports): </li></ul><ul><li>Provides staff with appropriate orientation, integration, guidance, and training on Client and FSP Clinical Operations systems and processes </li></ul><ul><li>Provides ongoing oversight of individual FSP Clinical Operations staff (collaborating with Client as required) </li></ul><ul><li>Facilitates, communicates, and addresses operational and/or performance issues including problem identification and resolution, coaching/mentoring of assigned staff, and escalation as appropriate to FSP Clinical Operations and Client </li></ul><ul><li>Supports and promotes staff professional development; assesses and provides opportunities for soft skills development </li></ul><ul><li>Conducts one on one meetings with direct reports, based on program requirements </li></ul><ul><li>Reviews and approves time and expenses in the applicable Time Management System </li></ul><ul><li>Conducts annual and ad hoc performance evaluations for all direct reports, as applicable </li></ul><ul><li>Hires, retains and develops a skilled, experienced, and motivated team </li></ul><ul><li>Minimizes regrettable turnover </li></ul><ul><li>Supports implementation of retention strategies for assigned staff o Oversees onboarding and offboarding of staff, as applicable o Reviews and approves content of curriculum vitaes (CVs), and conducts job description reviews for staff </li></ul><ul><li>Oversees training compliance of staff related to SOPs, systems, and processes </li></ul><ul><li>May provide mentoring to Associate level managers, as needed o Serves as a key communication liaison between FSP Clinical Operations Management and staff </li></ul>Collaboration <ul><li>Interacts closely with interdepartmental functions (e.g., Training, Quality, Contracts, Recruiting, Finance, etc.), as well as Client representatives, depending upon scope of services and structure </li></ul><ul><li>Collaborates with Quality to ensure adherence to ICH/GCP guidelines </li></ul><ul><li>Observes, collects, and analyzes FSP Clinical Operational issues to discuss with/resolve on behalf of FSP Clinical Operations management </li></ul><ul><li>Assists FSP Clinical Operations management with program/projects as necessary </li></ul><ul><li>May collaborate with interdepartmental functions to create business proposals including Request for Information/Request for Proposals (RFI/RFPs) to meet each Client’s specifications </li></ul><ul><li>Supports efforts to identify opportunities for increased quality and efficiency </li></ul> Compliance with Parexel Standards <ul><li>Complies with required training curriculum </li></ul><ul><li>Completes timesheets accurately as required </li></ul><ul><li>Submits expense reports as required </li></ul><ul><li>Updates CV as required </li></ul><ul><li>Maintains a working knowledge of and complies with Parexel processes, ICH-GCPs and other applicable requirements </li></ul>Skills: <ul><li>Ability to motivate direct reports </li></ul><ul><li>Effective interpersonal and communication skills, both written and verbal </li></ul><ul><li>Self-motivated, detail-oriented, and flexible </li></ul><ul><li>Well-developed planning, observation, prioritization, analytical, and problem-solving skills </li></ul><ul><li>Independent judgment and decision-making skills with respect to functional responsibilities including innovation, originality, and creativity </li></ul><ul><li>Strong computer skills with MS-Office products such as, but not limited to, Excel, Word, and PowerPoint </li></ul><ul><li>Proficient in written and spoken English required </li></ul><ul><li>Proficient in local language (as applicable), preferred </li></ul> Knowledge and Experience: <ul><li>Minimum 5+ years of clinical operations experience; prior line management experience, or prior demonstrated leadership experience; FSP Clinical Operations experience preferred </li></ul><ul><li> Comprehensive knowledge of FDA and/or local regulations and ICH/GCP guidelines, and strong working knowledge of the drug development process and clinical trial operations </li></ul><ul><li> Previous experience working in a remote office environment and managing remote staff preferred </li></ul> Education: <ul><li>Bachelor’s Degree or equivalent, or other required experience confirmed to be equivalent during the hiring process </li></ul>

Back to blog

DISCLAIMER