[Hiring] Manager, FSP Clinical Operations @Parexel

Role Description

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
  • 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 conducts interviews with potential candidates based on Client requirements and selects staff for hire (with/without Client input).
  • 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.
  • Oversees onboarding and offboarding of staff, as applicable.
  • 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.
  • 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.

Qualifications

• 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.

Requirements

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

Company Description