Fsp Manager

Spain, Remote

**Job ID** R0000019533

**Category** Clinical Trials

**ABOUT THIS ROLE**:
**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
- 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

**Skills 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

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