Job Description
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.
The Associate Manager, FSP Clinical Operations is responsible for the following:
• Assists FSP Clinical Operations Management with activities in support of contracted services
• Conducts direct performance management of assigned staff to support Client FSP Clinical Operations activities
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:
o May assist with the implementation, management, and closeout of Client programs, as required
o May develop interview tools and conduct interviews with potential candidates based on Client requirements and selects staff for hire (with/without Client input)
o 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
o 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
o Proactively manages program-level expectations, Key Performance Indicators (KPIs), and metrics
o Oversees program transitions to ensure proper training, adequate project support, and to ensure the resource is aware of program expectations
o Utilizes tools and systems to proactively collect, track, and analyze compliance/performance metrics
o 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):
o Provides staff with appropriate orientation, integration, guidance, and training on Client and FSP Clinical Operations systems and processes
o Provides ongoing oversight of individual FSP Clinical Operations staff (collaborating with Client as required)
o 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
o Supports and promotes staff professional development; assesses and provides opportunities for soft skills development
o Conducts one on one meetings with direct reports, based on program requirements
o Reviews and approves time and expenses in the applicable Time Management System
o Conducts annual and ad hoc performance evaluations for all direct reports, as applicable
o Hires, retains and develops a skilled, experienced, and motivated team o Minimizes regrettable turnover
o Supports implementation of retention strategies for assigned staff
o Oversees onboarding and offboarding of staff, as applicable o Reviews and approves content of curriculum vitaes (CVs), and conducts job description reviews for staff
o Oversees training compliance of staff related to SOPs, systems, and processes
o 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 Client’s 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:
Previous experience working in a remote office environment and managing remote staff preferred
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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.