Trial Master File Operations Manager

Manager, TMF Operations

Manager, TMF Operations

Syneos Health® is a leading fully-integrated life sciences services organization built to accelerate customer success. We partner with innovators at every point across the drug development and commercialization continuum, helping them navigate complexity, anticipate change and accelerate progress.

Our Clinical Solutions team members act with a drug development mindset, applying their years of experience and deep expertise to truly understand customer needs and represent those in the solutions we shape.

Whether you join us in a Functional Service Provider partnership or a Full-Service environment, you’ll collaborate with passionate problem solvers, innovating as a team to help our customers achieve their goals. We are agile and driven to deliver – for one another, our customers, and, most importantly, for those in need.

Discover what your 25,000 future colleagues already know:

Why Syneos Health
• We are passionate about developing our people, through career development and progression; supportive and engaged line management; technical and therapeutic area training; peer recognition and total rewards program.
• We are committed to building an inclusive culture – where you can authentically be yourself. Central to this is our purpose – Driven to Deliver – which captures the passion of our colleagues to show up each day and shape solutions that have the ability to dramatically impact someone’s life. 
• We are continuously building the company we all want to work for and our customers want to work with. Why? Because we know that when we bring together smart colleagues from across the world, we can shape the future of healthcare, driving impact for customers and defining the pace of patient progress. 

Job Responsibilities

JOB TITLE: Manager, Trial Master File (TMF) Operations
Clinical Solutions

Location - IND - Hyderabad - Hybrid

Experience 
08 years of must eTMF experience
At least 3 years in senior role managing New Hires onboarding, training, mentoring, and improving performance of junior roles
SME for TMF 
Managing New Hires onboarding, training, mentoring, and improving performance of junior roles
Stakeholder management outside of function / TMF (could be project teams, clients, vendors etc.) e.g.- SME  

Qualification 
Graduate degree. (Any Degree from Life sciences, background 
BSC / MSC / B. Pharm / M. Pharm /BDS / Biotech)

JOB SUMMARY
Manages TMF Operations staff including TMF Document Assistants, TMF Document Specialists, TMF 
Compliance Specialists TMF Analysts and/or TMF Leads. Oversees study assignments for TMF 
Operations staff. 
Monitors staff performance and regularly meets with employees to discuss 
performance. Conducts performance appraisals at designated time points throughout the year and 
directly supports staff professional development. Participates in the interviewing and selection process 
and provides ongoing support during the onboarding phase. Ensures staff adhere to the quality 
expectation and participates in process improvement efforts for the department.    
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%).

Job specification

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

Over the past 5 years, we have worked with 94% of all Novel FDA Approved Drugs, 95% of EMA Authorized Products and over 200 Studies across 73,000 Sites and 675,000+ Trial patients.

No matter what your role is, you’ll take the initiative and challenge the status quo with us in a highly competitive and ever-changing environment. Learn more about Syneos Health.

http://www.syneoshealth.com

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.

Experience Level

Mid Level