Job Opportunities API

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 FSP Program Lead, Data Management is responsible for the following: • Direct line management of FSP Data Management Operations managers and staff, and oversight of Client accounts. • Supporting FSP Data Management 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 Data Management 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 Data Management 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 Data Management 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 Data Managemnt 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 related initiatives • Collaborate with interdepartmental functions to create business proposals including Requests for Information/Requests for Proposal (RFIs/RFPs) to meet each Client's specifications General Operations and Functional/Business Unit Management • Participate in, champion or lead Parexel and department system/standards improvement activities or committees, task force groups as needed, including change management • Maintain an agreed level of productivity/billability and staff turnover • Complete 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 needed. • Ensure client and business needs are met and that all projects are optimally resourced with suitably experienced staff • Implement process improvements, in conjunction with Management team and Quality Management Group, in response to client and team feedback and quality audits • Look within and beyond CRS to encourage teamwork, quality and productivity efforts to the benefit of CRS and Parexel • May manage multiple countries, sub-region/s and/or subcontractors • Follow up departmental metrics, drive team members to meet departmental goals • Participate in departmental meetings and training initiatives, project team meetings, and maintain relationships with other departments, clients, and regulatory agencies as necessary • Implement 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 staff Regional Management • Establishes FSP Data Management 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/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 the development of 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 are met and monitored 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 wider team • Ability to work across multiple and varied programs projects/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 required Knowledge and Experience : • Minimum 5+ years of FSP Data Management Leadership experience in a CRO setting; and a minimum 3 years of previous line management experience • Direct experience with FSP Program Leadership in the Data Management function • 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 Education: • Educated to degree level (biological science, pharmacy, or other health-related discipline preferred) or equivalent nursing qualification or relevant clinical other equivalent experience.