FSP Program Lead, Data Management

FSP Program Lead, Data Management

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.

Experience Level

Senior Level