Are you a strategic FSP Data Management leader who thrives at the intersection of people leadership, client partnership, and operational excellence?
Join our growing FSP team and play a critical role in delivering innovative clinical trial solutions that help bring life-changing therapies to patients worldwide.
Experience and knowledge working in a FSP environment, specifically overseeing the Data Management function is required.
Job Summary:
The FSP Program Lead - Data Management is responsible for the following: + Direct line management of FSP Data Management 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.

\\#LI-CF1 \\#LI-REMOTEEEO Disclaimer Parexel is an equal opportunity employer. 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FSP Program Lead/FSP Leadership - Data Management