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Associate Director, FSP Clinical Operations / FSP Program Lead

External
Parexel logoParexel · Remote
Full-timeRemoteToday
Clinical TrialsComplianceMentoring
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Benefits

Health insurance

Additional Information

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. Job Summary: The Associate Director, FSP Clinical Operations is responsible for the following: 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/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/ 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 Line Management 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 Leads, manages, and develops direct reports to improve efficiency and effectiveness at prioritizing work and to ensure performance meets or exceeds business and personal goals/objectives, as well as departmental and project and/or program productivity and quality metrics Facilitates, communicates, and addresses operational and/or performance issues including problem identification and resolution, coaching/mentoring of assigned staff, and escalation 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 the required knowledge to fulfill duties 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 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 in developing managers and ensures a talented pipeline of management staff within the department or function Oversees onboarding and onboarding 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 Collaboration Collaborates with interdepartmental functions (e.g., Training, Quality, Contracts, Recruiting, Finance, Human Resources, etc.), as well as Client representatives, for initiatives and/or deliverables Supports execution of FSP Clinical Operations goals as required May serve as FSP Clinical Operations subject matter expert (SME) during audits and/or inspections Identifies and implements applicable process improvements as appropriate Participates in cross-industry initiatives/working groups which may include preparing and presenting at industry meetings, as applicable May serve as a working group member in SOP reviews or process rel


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