Associate Director, FSP Clinical Operations / FSP Program Lead

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.