Manager FSP Merck Monitoring

Position Purpose:

The Manager, FSP Operations is responsible for the following: Assist ExecuPharm (EP) Management in FSP Operations activities in support of contracted services Organizational Relationships: Reports to Senior Management, FSP Operations: refer to Organizational Chart for details regarding assigned role and associated reporting structure Manages FSP Operations assigned staff dependent upon Client structure and services Interacts closely with internal EP staff (i.e. Contracts, Recruiting, Finance, etc.) including EP Training and Quality Management as well as Client representatives, depending upon scope of services and structure Primary Duties: Duties may vary depending upon scope of Client services

Program Management May serve as a central point of contact (POC) between EP Senior Management and key Client personnel for contracted FSP Operations activities May be responsible for Program Management activities related to one or more programs Oversee implementation, management and closeout of Client programs as required Develop interview tools, conduct interviews with potential candidates based on Client requirements and select staff for hire (with/without Client input) Evaluate and deploy resources based on Client need, experience and availability (workload capacity management, contingency planning) and manage/analyze resource utilization to ensure cost effectiveness Lead/contribute to Client specific Operations meetings with Operations internal staff Manage program issues including problem identification, resolution, and escalation as appropriate to EP and Client Manage Client contractual obligations and accounting requirements Proactively manage program-level expectations Key Performance Indicators (KPIs) and metrics Oversee program transitions (training in program expectations) Comply with quality standards and timelines within assigned areas in compliance with local regulations (i.e. FDA, EMA, etc.), GCPs and SOPs

Line Management Oversee/manage FSP Operations staff (direct reports) Evaluate and deploy resources based on Client need, experience and availability Manage personnel and administrative issues Provide staff with appropriate orientation, integration, guidance and training on Client and EP systems and processes Provide ongoing oversight of individual FSP Operations staff (collaborating with Client as required) Facilitate, communicate, and address operational issues including problem identification and resolution, mentoring of assigned staff, and escalation as appropriate to EP and Client Conduct one on one meetings Review and approve time and expenses in EP Time Management System (TMS) Conduct annual and ad hoc performance evaluation for all direct reports, as applicable General Collaborate with EP Quality Management to ensure adherence to ICH guidelines/GCPs Utilize EP tools and systems to proactively collect, track, analyze compliance/performance metrics Observe, collect and analyze FSP Operations issues to discuss with/resolve on behalf of EP FSP Operations Management Assist FSP Operations Management with FSP Operations programs, as necessary Assist EP Business Development with activities (as required) including, but not limited to, preparation of requests for information, proposals and business development presentations Complete training assigned by Client and/or EP, as necessary, including general training requirements, SOPs and system and process-related training Adhere to EP and Client SOPs and processes, as appropriate QualificationsSkills and Education: Minimum BS or BA (biological sciences or nursing preferred) or nursing qualification such as RN or other experience confirmed to be equivalent during the hiring process 5+ years of clinical operations experience Prior line management experience is preferred Comprehensive knowledge of local regulations (i.e. FDA, EMA, etc.) and GCP/ICH guidelines Proficient interpersonal and communication skills, both written and verbal Self- motivated, detail-oriented, and flexible Planning, observation, prioritization, analytical and problem-solving skills Independent judgment and decision-making skills including innovation, originality and creativity Previous experience working in a remote office environment and managing remote workers is preferred #INHTF EEO DisclaimerParexel is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to legally protected status, which in the US includes race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.