[Remote] Associate Director, FSP Clinical Operations / FSP Program Lead

Note: The job is a remote job and is open to candidates in USA. Parexel is a global leader in the clinical research industry, dedicated to improving the world's health. The Associate Director, FSP Clinical Operations is responsible for managing FSP Clinical Operations staff, ensuring high-quality deliverables for client projects, and promoting new business opportunities.ResponsibilitiesDirect line management of FSP Clinical Operations managers and staff, and oversight of Client accountsSupporting FSP Clinical Operations business objectives, including ensuring on-time/high quality deliverablesResourcing Client projects with qualified staff, and working to retain and develop staffPromoting new business by participating in project bids and Client presentations as appropriateResponsible for execution and oversight of Program Management activities related to one or more programsMay serve as central point of contact (POC) for and between Senior Management and key Client personnel for contracted FSP Clinical Operations activitiesPlans and manages logistics, infrastructure, and resources related to FSP services to meet Client needs/timelines/ deliverablesCollaborates with Client to implement and operationalize short- and long-term strategiesDevelops and manages Communication and Escalation plans/processes, as applicableOversees Client Governance as required; prepares/presents at meetings as applicableOversees 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 deliverablesManages compliance with Client Key Performance Indicators (KPIs), utilizing applicable tools and systems to collect, track, and analyze associated dataLeads 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 basisOversees and/or manages issue escalation and resolution, including corrective and Preventive Actions (CAPA) development when necessaryManages and oversees FSP Clinical Operations functional and associated management staff dependent upon Client structure and servicesCoordinates 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 candidatesLeads, 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 metricsFacilitates, 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 ClientHires, retains, and develops a skilled, experienced, and motivated teamMinimizes regrettable turnoverProvides technical support to team members and managers to ensure they have the required knowledge to fulfill dutiesSupports and promotes staff professional development; assesses and provides opportunities for soft skills developmentConducts one on one meetings with direct reports, based on program requirementsObserves, collects, analyzes, and communicates FSP Clinical Operations problems/issues, develops action plans or alternatives for resolution, and escalates as appropriateConducts formal performance reviewsWorks with Senior Management in developing managers and ensures a talented pipeline of management staff within the department or functionOversees onboarding and onboarding of staff, as applicableReviews and approves content of curriculum vitaes (CVs), and conducts job description reviews for staffOversees training compliance of staff related to SOPs, systems, and processesCollaborates with interdepartmental functions (e.g., Training, Quality, Contracts, Recruiting, Finance, Human Resources, etc.), as well as Client representatives, for initiatives and/or deliverablesSupports execution of FSP Clinical Operations goals as requiredMay serve as FSP Clinical Operations subject matter expert (SME) during audits and/or inspectionsIdentifies and implements applicable process improvements as appropriateParticipates in cross-industry initiatives/working groups which may include preparing and presenting at industry meetings, as applicableMay serve as a working group member in SOP reviews or process related initiativesCollaborate with interdepartmental functions to create business proposals including Requests for Information/Requests for Proposal (RFIs/RFPs) to meet each Client's specificationsParticipate in, champion or lead Parexel and department system/standards improvement activities or committees, task force groups as needed, including change managementMaintain an agreed level of productivity/billability and staff turnoverComplete routine administrative tasks in a timely manner (e.g. timesheets, training, travel expense claims). Manage compliance with travel and billability guidelines for department, region or function, where appropriate. Travel as neededEnsure client and business needs are met and that all projects are optimally resourced with suitably experienced staffImplement process improvements, in conjunction with Management team and Quality Management Group, in response to client and team feedback and quality auditsLook within and beyond CRS to encourage teamwork, quality and productivity efforts to the benefit of CRS and ParexelMay manage multiple countries, sub-region/s and/or subcontractorsFollow up departmental metrics, drive team members to meet departmental goalsParticipate in departmental meetings and training initiatives, project team meetings, and maintain relationships with other departments, clients, and regulatory agencies as necessaryImplement process improvements, in conjunction with Senior Management and Quality, in response to Client and team feedback and/or audits Serves as a key communication liaison between FSP Operations Management and staffEstablishes FSP Clinical Operations solutions for prospective, newly established, and existing Clients specializing in various outsourcing and insourcing modelsWorks with Senior Leadership and FSP Sales to develop market positioning and key messagingIdentifies potential opportunities for additional business with existing ClientsDevelops work orders/service orders for Client work and ensures continued maintenance for assigned ClientsManages Client-driven initiatives to standardize all phases of the clinical trials process, including the development of metrics to measure performance and enhance productivity and effectivenessCollaborates 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 are met and monitored on an ongoing basisManages Client relationshipsSkillsMinimum 5+ years of FSP Clinical Operations experience; and a minimum 3 years of previous line management experienceDirect experience with Full Hybrid FSP Flex Model & Staff Augmentation Experience - delivery oversight and resourcing responsibilities across hybrid FSP Flex Monitoring models and Staff Augmentation rolesDirect experience with FSP Resourcing Projections, Billing & Financial Tracking - experience with workforce forecasting, billing processes, and financial tracking in an FSP contextIn-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 guidelinesKnowledge of and demonstrated experience with application of regional (including country specifications) talent acquisition, labor/working practices, retention strategies, and cultural differences, as applicablePrevious 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 organizationExperience working in customer service/FSP outsourcing model with experience managing and forecasting resource allocationEducated to degree level (biological science, pharmacy, or other health-related discipline preferred) or equivalent nursing qualification or relevant clinical other equivalent experienceExceptional 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 resolutionDemonstrated ability to effectively interact with all levels of management and other functions within an organizationDemonstrated 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 wider teamAbility to work across multiple and varied programs projects/tasks and prioritize workload effectively with attention to detailWell-developed planning, observation, analytical, and problem-solving skillsIndependent judgment and decision-making skills with respect to functional responsibilities including innovation, originality, and creativitySelf-motivated, detail-oriented, and flexibleStrong computer skills with MS-Office products such as, but not limited to, Excel, Word, and PowerPointProficient in written and spoken English requiredCompany OverviewPAREXEL is a biopharmaceutical services company that focuses on the development and commercialization of new medical therapies worldwide. It is a sub-organization of EQT. It was founded in 1983, and is headquartered in Waltham, Massachusetts, USA, with a workforce of 10001+ employees. Its website is http://www.parexel.com.Company H1B SponsorshipParexel has a track record of offering H1B sponsorships, with 14 in 2026, 32 in 2025, 46 in 2024, 41 in 2023, 51 in 2022, 54 in 2021, 33 in 2020. Please note that this does not guarantee sponsorship for this specific role.