Associate Director, FSP Clinical Operations / FSP Program Lead

About this role

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 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 is required.
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.

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…