Senior Manager, FSP Clinical Operations

When our values align theres no limit to what we can achieve.

At Parexel we all share the same goal - to improve the worlds 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 were committed to making a difference.

Key Accountabilities:

Program Management

• May serve as a central Point of Contact (POC) between Senior Management and key Client personnel for contracted FSP Clinical Operations activities

• May serve as a liaison to one or more Clients

• May be responsible for Program Management activities related to one or more programs:

• May assist with the implementation management and closeout of Client programs as required

• May develop interview tools and conduct interviews with potential candidates based on Client requirements and selects staff for hire (with/without Client input)

• Evaluates and deploys resources based on Client need experience and availability (workload capacity management contingency planning) and manages/analyzes resource utilization to ensure cost effectiveness

• May lead/contribute to Client-specific Operations meetings with Operations internal staff o Manages program issues including problem identification resolution and escalation as appropriate to FSP Clinical Operations and Client

• Proactively manages program-level expectations Key Performance Indicators (KPIs) and metrics

• Oversees program transitions to ensure proper training adequate project support and to ensure the resource is aware of program expectations

• Utilizes tools and systems to proactively collect track and analyze compliance/performance metrics

• Adheres to quality standards and timelines within assigned areas in compliance with local regulations (i.e. FDA EMA etc.) ICH/GCPs and SOPs

Line Management

• Manages FSP Clinical Operations assigned staff dependent upon Client structure and services

• Oversees/Manages personnel and administrative issues for assigned FSP Clinical Operations staff (direct reports):

• Provides staff with appropriate orientation integration guidance and training on Client and FSP Clinical Operations systems and processes

• Provides ongoing oversight of individual FSP Clinical Operations staff (collaborating with Client as required)

• Facilitates communicates and addresses operational and/or performance issues including problem identification and resolution coaching/mentoring of assigned staff and escalation as appropriate to FSP Clinical Operations and Client

• 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

• Reviews and approves time and expenses in the applicable Time Management System

• Conducts annual and ad hoc performance evaluations for all direct reports as applicable

• Hires retains and develops a skilled experienced and motivated team o Minimizes regrettable turnover

• Supports implementation of retention strategies for assigned staff

• Oversees onboarding and offboarding 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

• Serves as a key communication liaison between FSP Clinical Operations Management and staff

Collaboration

• Interacts closely with interdepartmental functions (e.g. Training Quality Contracts Recruiting Finance etc.) as well as Client representatives depending upon scope of services and structure

• Collaborates with Quality to ensure adherence to ICH/GCP guidelines

• Observes collects and analyzes FSP Clinical Operational issues to discuss with/resolve on behalf of FSP Clinical Operations management

• Assists FSP Clinical Operations management with program/projects as necessary

• May collaborate with interdepartmental functions to create business proposals including Request for Information/Request for Proposals (RFI/RFPs) to meet each Clients specifications

• Supports efforts to identify opportunities for increased quality and efficiency

Compliance with Parexel Standards

• Complies with required training curriculum

• Completes timesheets accurately as required

• Submits expense reports as required

• Updates CV as required

• Maintains a working knowledge of and complies with Parexel processes ICH-GCPs and other applicable requirements

Skills:

• Ability to motivate direct reports

• Effective interpersonal and communication skills both written and verbal

• Self-motivated detail-oriented and flexible

• Well-developed planning observation prioritization analytical and problem-solving skills

• Demonstrated independent judgment and decision-making skills with respect to functional responsibilities including innovation originality and creativity

• Strong computer skills with MS-Office products such as but not limited to Excel Word and PowerPoint

• Proficient in written and spoken English required

• Proficient in local language (as applicable) preferred

Knowledge and Experience:

• Minimum 4 years of clinical operations experience; demonstrated leadership coaching or mentoring experience preferred; FSP Clinical Operations experience preferred

• Comprehensive knowledge of FDA and/or local regulations and ICH/GCP guidelines and strong working knowledge of the drug development process and clinical trial operations

• Previous experience working in a remote office environment and managing remote staff preferred

Education:

• Bachelors Degree or equivalent or other required experience confirmed to be equivalent during the hiring process