Associate Director, FSP Clinical Operations / FSP Program Lead

Responsibilities

• Direct line management of FSP Clinical Operations managers and staff, and oversight of Client accounts.
• Supporting FSP Clinical Operations business objectives, ensuring on-time/high quality deliverables.
• Resourcing Client projects with qualified staff, and working to retain and develop staff.
• Promoting new business by participating in project bids and Client presentations as appropriate.
• Responsible for execution and oversight of Program Management activities related to one or more programs.
• May serve as central point of contact (POC) for and between Senior Management and key Client personnel for contracted FSP Clinical Operations activities.
• Plans and manages logistics, infrastructure, and resources related to FSP services to meet Client needs/timelines/ deliverables.
• Collaborates with Client to implement and operationalize short- and long-term strategies.
• Develops and manages Communication and Escalation plans/processes, as applicable.
• Oversees Client Governance as required; prepares/presents at meetings as applicable.
• Oversees performance management of staff who support contracted FSP activities and collaborates with FSP Clinical Operations Management to ensure staff are technically proficient and able to satisfy Client expectations and deliverables.
• Manages compliance with Client Key Performance Indicators (KPIs), utilizing applicable tools and systems to collect, track, and analyze associated data.
• Leads Client-specific FSP meetings with internal program team, ensuring that contractual requirements related to FSP Clinical Operations activities are met and monitored on an ongoing basis.
• Oversees and/or manages issue escalation and resolution, including corrective and Preventive Actions (CAPA) development when necessary.
• Manages and oversees FSP Clinical Operations functional and associated management staff dependent upon Client structure and services.
• Coordinates and manages resourcing process including hiring, selection, and onboarding/offboarding of staff which may include development of interview tools, as well as conducting interviews with potential candidates.

Requirements

• Minimum 5+ years of FSP Clinical Operations experience; and a minimum 3 years of previous line management experience.
• Direct experience with Full Hybrid FSP Flex Model & Staff Augmentation Experience – delivery oversight and resourcing responsibilities across hybrid FSP Flex Monitoring models and Staff Augmentation roles.
• Direct experience with FSP Resourcing Projections, Billing & Financial Tracking – experience with workforce forecasting, billing processes, and financial tracking in an FSP context.
• In-depth knowledge of overall drug development process and clinical trial operations with a comprehensive understanding of local regulations (i. e., FDA, EMA, etc.) and ICH/GCP guidelines.
• Knowledge of and demonstrated experience with application of regional (including country specifications) talent acquisition, labor/working practices, retention strategies, and cultural differences, as applicable.
• Previous experience working in a remote office environment and independently managing remote staff, with ability to effectively oversee/lead a team and promote collaboration in a matrix organization.
• Experience working in customer service/FSP outsourcing model with experience managing and forecasting resource allocation.
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