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Assoc Dir, TMF Operations

Syneos Health/ inVentiv Health Commercial LLC
United States
May 15, 2022

Associate Director, Trial Master File (TMF) Operations (Fully Remote - US/Canada)

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

* #Syneos Health Life 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

* Oversees and approves courses action for staff members on salary administration, interviewing and selection, terminations, professional development, performance appraisals, job description preparation, and employee counseling. Works with and advises staff on administrative policies and procedures, technical problems, priorities, and methods. Supports team managers on all administrative or departmental activities.

* Facilitates processes, resourcing, and communications within a department or across departments. Plans and negotiates resources with line management of functional areas. Serves as a departmental point of escalation for internal and external customers.

* Supports management in reviewing, approving, and presenting prepared information at project or departmental review meetings. Develops and implements training programs for appropriate departmental teams.

* Supports with financial management tasks of projects, as well as strategy development for process improvement. Facilitates and supports project reviews with Clinical Operations staff, focusing on budget, schedule, and risk analysis.

* Assists in the collection of operational metrics to Senior Management for TMF Operations.

* Leads teams of subject matter experts in the development and review of Standard Operating Procedures (SOPs) and Work Instructions (WI) to support new or existing processes. Develops and implements strategies and tools for tracking contract management team metrics/cycle times. Oversees all quality control efforts of individual departmental teams.

* Set priorities, decide work load distribution, forecast demand and drive resource / budget planning to ensure adequate delivery of document management services.

* Supports business development efforts and contributes to the generation of new business for TMF Operations, as applicable.

* Assists in maintaining paper and electronic clinical document technical standards to meet internal and external requirements.

* Establishes and maintains training materials for assigned area.

* Represents the Company at professional meetings or seminars.

Other Responsibilities:

* Performs other work-related duties as assigned. Moderate travel may be required (up to 50%).


What we're looking for

* Graduate degree preferred and 10 years related experience with degree in the science/health care field, plus extensive experience in an operational clinical trials environment, or equivalent combination of education and experience that provide the skills and knowledge necessary to perform the job.

* Some experience in a management position.

* Experience in a Contract Research Organization or Pharmaceutical/Biotechnology company is preferred.

* Experience working in a matrix-structured environment with multiple product lines is essential.

* Requires in-depth knowledge of relevant regulatory agencies and strong understanding and usage of medical terminology.

* Ability to handle multiple tasks to meet deadlines in a high stress environment is essential.

* Requires effective organizational, presentation, documentation, analytical and interpersonal skills with demonstrated ability to lead and motivate a matrix team.

* The ability to implement, control and understand productivity measures is essential and a good understanding of financial control is deemed a strong requirement.

* Proficiency in Microsoft Office Suite (Word, Excel, and Power Point), email, and voicemail.

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.

Primary Location

North America - US Home-Based


Clinical Monitoring





Employee Status