Syneos Health

Manager, TMF Operations

Farnborough-1-Pinehurst, GBR
13 Apr 2021
26 Apr 2021
Full Time
Contract Type
Experience Level
Experienced (non-manager)
Manager, Trial Master File (TMF) Operations

Come discover what our 25,000+ employees already know: work here matters everywhere. We're a growing and evolving biopharmaceutical industry leader, which means you'll have endless opportunities to work with experts around the world and build the career you've dreamed of.
As a part of the Syneos Health team, you'll help us deliver results for a rewarding reason - we improve patients' lives around the world. Because to us, a patient isn't just a number, they're our family, friends, and neighbors.

Why Syneos Health
• #SyneosHealthLife means we're committed to our Total Self culture - where everyone can authentically be themselves. Our Total Self culture is what unites us globally, and we know every person's unique contributions make a difference.
• We believe our success is a direct result of the people who are driving it - you! We value your dedication to care for our customers and patients, so we want to focus on taking care of you. That's why we offer a comprehensive benefits program encompassing your total health - physical, mental and financial.
• We are continuously building the company we all want to work for and our customers want to work with. Why? Because when we bring together diversity of thoughts, backgrounds, cultures, and perspectives - we're able to create a place where everyone feels like they belong.

Job responsibilities
• Participates in and directs activities related to department staff operations such as interviewing and selection, professional development, training, performance management, and employee counseling and separations.
• Conducts courses of action on interviewing and selection, terminations, professional development, performance appraisals and employee counseling.

• Works with and advises staff on administrative policies and procedures, technical problems, priorities and methods.
• Assigns resources and manages transitions of ongoing studies/processes/workflows.
• Manages periodic and ongoing compliance to quality and performance standards of direct reports.
• Ensures successful delivery of the TMF Operations Key Performance Indicators for direct reports.
• Ensures staff utilization meets department goal, reviews and approves timecards/expenses by established deadline and reviews and ensures staff training compliance.
• Prepares and participates in audits/inspections to ensure ongoing readiness of the TMF.
• Designs and/or delivers TMF training in various formats via teleconference, video conference, and/or in person.
• Actively involved and/or leads department and business unit improvement initiatives.
• Coordinates with staffing vendor to manage temporary and/or flexible workforce, as applicable.
• Controls access to the Document Control Room according to applicable Standard Operating Procedures (SOPs) and Work Instructions (WIs). Responsible for maintenance of the physical space in the Document Control work area, as applicable.
• Performs other work-related duties as assigned. Minimal travel may be required (up to 25%).What we're looking for
• Undergraduate degree. Moderate experience in a clinical and/or medical environment that includes working with regulatory records.
• Experience with direct line management of staff highly preferred.
• Strong knowledge of appropriate regulations and guidelines with respect to regulatory documents and familiarity with medical terminology.
• Demonstrated leadership skills.
• Strong verbal, written, and organizational skills with a team-oriented approach.
• Proficiency in Electronic Document Management Systems, web-based systems, Microsoft Office Suite (Word, Excel, and PowerPoint), email, and voicemail.
• Ability to handle multiple tasks to meet deadlines in a dynamic environment.

Get to know Syneos Health
We are the only full-service biopharmaceutical solutions company in the world. That means we bring together the best clinical and commercial minds to create a better, smarter, faster way to get medicines into the hands of patients who need it most. Learn more about Syneos Health.

Additional Information:
Tasks, duties, and responsibilities as listed in this job description are not exhaustive. The Company, at its sole discretion and with no prior notice, may assign other tasks, duties, and job responsibilities. Equivalent experience, skills, and/or education will also be considered so qualifications of incumbents may differ from those listed in the Job Description. The Company, at its sole discretion, will determine what constitutes as equivalent to the qualifications described above. Further, nothing contained herein should be construed to create an employment contract. Occasionally, required skills/experiences for jobs are expressed in brief terms. Any language contained herein is intended to fully comply with all obligations imposed by the legislation of each country in which it operates, including the implementation of the EU Equality Directive, in relation to the recruitment and employment of its employees. The Company is committed to compliance with the Americans with Disabilities Act, including the provision of reasonable accommodations, when appropriate, to assist employees or applicants to perform the essential functions of the job.

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