Associate Director, FSP Clinical Operations / FSP Program Lead

Job Summary Direct line management of FSP Clinical Operations managers and staff, and oversight of Client accounts. Supporting FSP Clinical Operations business objectives, including ensuring on‑time and 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. Key Accountabilities Program Management 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 and 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, preparing and presenting at meetings as applicable. Oversees performance management of staff who support contracted FSP activities, collaborating with FSP Clinical Operations management to ensure technical competence and client satisfaction. 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 contractual requirements related to FSP Clinical Operations activities are met and monitored. Oversees and/or manages issue escalation and resolution, including corrective and preventive actions (CAPA) development when necessary. Line Management Manages and oversees FSP Clinical Operations functional or associated management staff dependent upon Client structure and services. Coordinates and manages resourcing process including hiring, selection, onboarding/offboarding of staff, and developing interview tools and conducting interviews. Leads, manages, and develops direct reports to improve efficiency and effectiveness at prioritizing work, ensuring performance meets or exceeds business and personal goals, departmental, project, and program productivity and quality metrics. Facilitates, communicates, and addresses operational and performance issues through problem identification and resolution, coaching/mentoring assigned staff, and escalating as appropriate to senior management and Client. Hires, retains, and develops a skilled, experienced, and motivated team. Minimizes regrettable turnover. Provides technical support to team members and managers to ensure they have required knowledge to fulfill duties. Supports and promotes staff professional development, assessing and providing opportunities for soft‑skills development. Conducts one‑on‑one meetings with direct reports based on program requirements. Observes, collects, analyzes, and communicates FSP Clinical Operations problems/issues, develops action plans or alternatives for resolution, and escalates as appropriate. Conducts formal performance reviews. Works with senior management to develop managers and ensures a talented pipeline of management staff within the department or function. Oversees onboarding and orientation of staff, as applicable. Reviews and approves content of CVs, and conducts job description reviews for staff. Oversees training compliance of staff related to SOPs, systems, and processes. Collaboration Collaborates with interdepartmental functions (e.g., Training, Quality, Contracts, Recruiting, Finance, Human Resources) and Client representatives for initiatives and deliverables. Supports execution of FSP Clinical Operations goals as required. May serve as FSP Clinical Operations subject matter expert (SME) during audits and inspections. Identifies and implements applicable process improvements as appropriate. Participates in cross‑industry initiatives/working groups, preparing and presenting at industry meetings as applicable. May serve as a working group member in SOP reviews or process‑related initiatives. Collaborates with interdepartmental functions to create business proposals including requests for information and proposals (RFIs/RFPs) to meet each Client’s specifications. General Operations and Functional/Business Unit Management Participates in, champions or leads Parexel and department system/standards improvement activities or committees, task force groups as needed, including change management. Maintains an agreed level of productivity, billability and staff turnover. Completes routine administrative tasks in a timely manner (e.g., timesheets, training, travel expense claims). Manages compliance with travel and billability guidelines for the department, region or function, where appropriate. Travel as needed. Ensures client and business needs are met and that all projects are optimally resourced with suitably experienced staff. Implements process improvements, in conjunction with management team and Quality Management Group, in response to client and team feedback and quality audits. Encourages teamwork, quality and productivity efforts to the benefit of CRS and Parexel. May manage multiple countries, sub‑regions and/or subcontractors. Follows up departmental metrics, driving team members to meet departmental goals. Participates in departmental meetings and training initiatives, project team meetings, and maintains relationships with other departments, clients, and regulatory agencies as necessary. Serves as a key communication liaison between FSP Operations Management and staff. Regional Management Establishes FSP Clinical Operations solutions for prospective, newly established, and existing Clients specializing in various outsourcing and insourcing models. Works with senior leadership and FSP Sales to develop market positioning and key messaging. Identifies potential opportunities for additional business with existing Clients. Develops work orders and service orders for Client work and ensures continued maintenance for assigned Clients. Manages Client‑driven initiatives to standardize all phases of the clinical trials process, including developing metrics to measure performance and enhance productivity and effectiveness. Collaborates with applicable departments and appropriate Client personnel, on a strategic level, to ensure all operational aspects of contracted services meet time, quality, and cost targets, and monitors contractual requirements on an ongoing basis. Manages Client relationships. Skills Exceptional interpersonal skills and communication skills, both written and verbal, with the ability to persuade, negotiate, and moderate conflicts, and communicate problems/issues along with action plans or alternatives for resolution. Demonstrated ability to effectively interact with all levels of management and other functions within an organization. Demonstrated leadership in ensuring direct reports are communicating and coordinating efforts to provide superior services to the Client; strong ability to manage and motivate direct reports and the wider team. Ability to work across multiple and varied programs, projects, and tasks and prioritize workload effectively with attention to detail. Well‑developed planning, observation, analytical, and problem‑solving skills. Independent judgment and decision‑making skills with respect to functional responsibilities, including innovation, originality, and creativity. Self‑motivated, detail‑oriented, and flexible. Strong computer skills with MS‑Office products such as, but not limited to, Excel, Word and PowerPoint. Proficient in written and spoken English. Knowledge and Experience 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, overseeing delivery and resourcing responsibilities across hybrid FSP Flex and 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 the overall drug development process and clinical trial operations with a comprehensive understanding of local regulations (e.g., FDA, EMA) and ICH/GCP guidelines. Knowledge of and demonstrated experience with the application of regional 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 and 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. Education Educated to degree level (biological science, pharmacy, or other health‑related discipline preferred) or equivalent nursing qualification or other relevant clinical experience. EEO Disclaimer Parexel is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to legally protected status, which in the US includes race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status. #J-18808-Ljbffr