Manager, FSP Clinical Operations

Key Accountabilities:

Program Management

• May serve as a central Point of Contact (POC) between Senior Management and key Client personnel for contracted FSP Clinical Operations activities 

•  May serve as a liaison to one or more Clients 

• May be responsible for Program Management activities related to one or more programs: 

• Oversees implementation, management, and closeout of Client programs, as required 

• 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 

• Leads/contributes to Client-specific Operations meetings with Operations internal staff 

• Manages program issues, including problem identification, resolution, and escalation, as appropriate to FSP Clinical Operations and Client 

• Proactively manages program-level expectations, Key Performance Indicators (KPIs), and metrics

• Oversees program transitions to ensure proper training, adequate project support, and to ensure the resource is aware of program expectations

• Utilizes tools and systems to proactively collect, track, and analyze compliance/performance metrics 

• Adheres to quality standards and timelines within assigned areas in compliance with local regulations (i.e., FDA, EMA, etc.), ICH/GCPs, and SOPs

Line Management

• Manages FSP Clinical Operations assigned staff dependent upon Client structure and services 

• Oversees/Manages personnel and administrative issues for assigned FSP Clinical Operations staff (direct reports): 

• Provides staff with appropriate orientation, integration, guidance, and training on Client and FSP Clinical Operations systems and processes 

• Provides ongoing oversight of individual FSP Clinical Operations staff (collaborating with Client as required) 

• 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 

• Supports and promotes staff professional development; assesses and provides opportunities for soft skills development 

• Conducts one on one meetings with direct reports, based on program requirements

• Reviews and approves time and expenses in the applicable Time Management System 

• Conducts annual and ad hoc performance evaluations for all direct reports, as applicable 

• Hires, retains and develops a skilled, experienced, and motivated team

• Minimizes regrettable turnover 

• 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 

• Oversees training compliance of staff related to SOPs, systems, and processes

• May provide mentoring to Associate level managers, as needed o Serves as a key communication liaison between FSP Clinical Operations Management and staff

Collaboration

• 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

• Collaborates with Quality to ensure adherence to ICH/GCP guidelines

• Observes, collects, and analyzes FSP Clinical Operational issues to discuss with/resolve on behalf of FSP Clinical Operations management 

• Assists FSP Clinical Operations management with program/projects as necessary

• May collaborate with interdepartmental functions to create business proposals including Request for Information/Request for Proposals (RFI/RFPs) to meet each Client’s specifications 

• Supports efforts to identify opportunities for increased quality and efficiency

Compliance with Parexel Standards

• Complies with required training curriculum

• Completes timesheets accurately as required 

• Submits expense reports as required 

• Updates CV as required 

• Maintains a working knowledge of and complies with Parexel processes, ICH-GCPs and other applicable requirements

Skills: 

• Ability to motivate direct reports 

• Effective interpersonal and communication skills, both written and verbal 

• Self-motivated, detail-oriented, and flexible 

• Well-developed planning, observation, prioritization, analytical, and problem-solving skills 

• Independent judgment and decision-making skills with respect to functional responsibilities including innovation, originality, and creativity 

• Strong computer skills with MS-Office products such as, but not limited to, Excel, Word, and PowerPoint 

• Proficient in written and spoken English required 

• Proficient in local language (as applicable), preferred 

Knowledge and Experience:

• Minimum 5+ years of clinical operations experience; prior line management experience, or prior demonstrated leadership experience; FSP Clinical Operations experience preferred 

•  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 

•  Previous experience working in a remote office environment and managing remote staff preferred

Education: 

• Bachelor’s Degree or equivalent, or other required experience confirmed to be equivalent during the hiring process