FSP Program Lead – Data Management

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

📋 Description

• Oversee Client accounts and manage FSP Clinical Operations managers and staff directly.

• Support the business objectives of FSP Clinical Operations while ensuring timely and high-quality deliverables.

• Allocate qualified personnel to Client projects and focus on employee retention and development.

• Engage in project bidding and Client presentations to foster new business opportunities.

• Execute and oversee Program Management activities for one or more programs.

• Act as a liaison between Senior Management and key Client personnel.

• Plan and manage logistics, infrastructure, and resources for FSP services.

• Collaborate with Clients to develop and implement short- and long-term strategies.

• Create and manage communication and escalation plans.

• Supervise Client governance, performance management, KPIs, meetings, and contractual obligations.

• Manage issue escalation and resolution, including the development of CAPAs as needed.

• Coordinate hiring, selection, onboarding, offboarding, and resource planning processes.

• Lead, manage, coach, mentor, and conduct performance evaluations for direct reports.

• Provide technical support and supervise staff training and compliance efforts.

• Collaborate with Training, Quality, Contracts, Recruiting, Finance, Human Resources, Clients, and additional departments.

• Serve as a subject matter expert during audits and inspections.

• Identify and implement process improvements and engage in SOP and industry initiatives.

• Develop business proposals, RFIs, and RFPs.

• Maintain productivity, billability, employee turnover, departmental metrics, and administrative compliance.

• Establish FSP solutions and market positioning for both prospective and existing Clients.

• Develop and manage Client work orders and service orders.

• Manage Client relationships and standardize clinical trial processes across initiatives.

• Ensure that contracted services align with time, quality, cost, and regulatory requirements.

⛳️ Requirements

• At least 5+ years of experience in FSP Clinical Operations within a CRO environment.

• A minimum of 3 years of prior line management experience.

• Direct experience in FSP Program Leadership specifically within the Data Management function.

• Proven experience with FSP resourcing projections, billing, and financial tracking.

• Familiarity with workforce forecasting, billing processes, and financial tracking in an FSP setting.

• Extensive knowledge of drug development and clinical trial operations.

• Thorough understanding of local regulations, including FDA and EMA, as well as ICH/GCP guidelines.

• Experience with regional and country-specific talent acquisition, labor practices, retention strategies, and cultural nuances.

• Experience in remote working and managing remote staff within a matrix organization.

• Background in customer service/FSP outsourcing models and resource allocation forecasting.

• Outstanding written and verbal communication, interpersonal, persuasion, negotiation, and conflict resolution skills.

• Capable of interacting effectively with all levels of management and organizational functions.

• Proven leadership ability to manage and motivate direct reports and larger teams.

• Proficient in managing multiple programs, projects, and tasks while prioritizing effectively.

• Strong planning, observation, analytical, problem-solving, judgment, and decision-making skills.

• Self-motivated, detail-oriented, and adaptable.

• Proficient in computer skills, including Microsoft Excel, Word, and PowerPoint.

• Proficiency in written and spoken English.

• Degree-level education in biological science, pharmacy, or a related health discipline, or an equivalent nursing qualification or relevant clinical experience.

🏝️ Benefits

• Opportunities for professional development.

• Training for staff and development of soft skills.

• Career advancement opportunities and management pipeline development.

• Work environment that supports remote work.

• Opportunities for global and cross-functional collaboration.

• Travel as required.