Associate Director, FSP Clinical Operations / FSP Program Lead
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 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.
#LI-CF1
EEO Disclaimer
Parexel 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.
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 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.
#LI-CF1
EEO Disclaimer
Parexel 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.