FSP Manager, Clinical Operations

This is a fully remote position, open to applicants in India.

📋 Description

• Manages the daily operations of various clinical administration team members, providing direct coaching and developmental support to designated staff.

• Oversees resource allocation, alignment, training, and ongoing professional development for the assigned division or office.

• Ensures the implementation of all Clinical Administration initiatives to promote efficiency in proposed processes, consistency in execution, and quality output.

• Analyzes performance metrics and offers feedback to the team as needed to improve both individual and team performance.

• Develops and implements Working Practice Documents (WPDs) and Standard Operating Procedures (SOPs) as required.

• Creates and implements training processes for both clinical administration and clinical staff.

• Executes project-specific training activities for research staff, including mentoring new team members and other Clinical Managers.

• Performs additional duties and projects as assigned by PPD management.

⛳️ Requirements

• Bachelor's degree or equivalent and relevant formal academic/vocational qualification.

• Extensive clinical research experience (approximately 5+ years), including remote and clinical monitoring across all phases of the study life cycle, such as start-up, interim, and close-out.

• At least 1 year of leadership experience.

• Advanced knowledge of ICH GCP, relevant regulations, and PPD/Client procedural documents.

• In-depth understanding of all phases of clinical trials, particularly study start-up, maintenance, and close-out.

• Advanced skills in managing, motivating, and mentoring staff.

• Ability to analyze and oversee the clinical administration aspect of Business Development bids and contracts for multiple studies within designated division(s)/office(s).

• Strong familiarity with budgets, projects, and metrics.

• Capability to manage multiple tasks simultaneously, meet demanding timelines, and work efficiently in high-pressure situations.

• Exceptional organizational skills and strong attention to detail.

• Excellent communication and interpersonal abilities.

• Willingness to travel if necessary.

🏝️ Benefits

• Personal protective equipment may be required, including protective eyewear, garments, and gloves in certain instances.

• Health insurance.

• Flexible work arrangements.

• Opportunities for professional development.