Job Summary:The Associate Director, FSP Clinical Operations 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; and a minimum 3 years of previous line management experience
- Direct experience with Full Hybrid FSP Flex Model & Staff Augmentation Experience - delivery oversight and resourcing responsibilities across hybrid FSP Fllex Monitoring models and Staff Augmentation roles.
- 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.
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