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.
Are you a strategic FSP clinical operations 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 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 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 Clinical Operations 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 Clinical Operations 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.
EEO Disclaimer
is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to legally protected status, which in the US includes race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.
Originally posted on