TMF Study Owner

TransPerfect Is More Than Just a Job…
Our greatest asset is our people, and nothing is more important to us than ensuring that everyone knows that. Each of our 100+ offices has its own individual identity, and each also has its own unique rewards.

Who We Are:

TransPerfect is the world's largest provider of language services and technology solutions for global business. From offices in over 120 cities on six continents, TransPerfect offers a full range of services in 170+ languages to clients worldwide. More than 5,000 global organizations employ TransPerfect's GlobalLink® technology to simplify management of multilingual content. TransPerfect has global headquarters in New York, with regional headquarters in London and Hong Kong.

What You Will Be Doing:

The Study Owner (SO) works on behalf of clients as an extension to their study team. The Study Owner ensures a complete, contemporaneous and accurate Trial Master File (TMF) and electronic TMF (eTMF) across our clients’ clinical programs. Working with client study teams and functional leads, they assume a key role in the management of a study with a focus on study start up and the TMF with the goal of supporting inspection readiness.

• Participate in client Study Owner engagements and consistently deliver quality customer success
• Own and account for the TMF on behalf of our clients, across multiple studies and programs
• Support inspection readiness as a culture, and compliance with Good Clinical Practices (GCP) regulatory requirements
• Assist study teams with all study start-up activities utilizing Study Start Up, Clinical Trial Management Systems (CTMS) and eTMF systems
• Assist study teams with all maintenance and close out activities utilizing systems such as, but not limited to, CTMS and eTMF systems
• Create study-specific TMF Plans on behalf of clients
• Help ensure TMF plan compliance
• Ensure compliance with client Standard Operating Procedures (SOPs) and work instructions
• Meet with study teams to understand events/activities that would impact the TMF
• eTMF ongoing user management
• May be responsible for creation and or maintenance of events/placeholders or equivalent in the eTMF
• Resolve outstanding TMF queries on behalf of clients
• Complete periodic TMF quality reviews, at agreed intervals, and ensure documentation is present/complete in the TMF
• Identify and report to study leads on TMF trending issues/concerns, determining resolutions and course of actions
• Identify continuous improvement opportunities to enhance TMF operational efficiencies
• Monitor and assess the overall health of the TMF
• Storyboard creation and maintenance to assist with inspection readiness
• Support Audits/Inspections as needed
• Complete all other tasks that are deemed appropriate for this role and assigned by the manager/supervisor

Who We Are Looking For:

Your experience includes:

• Bachelor’s degree or its equivalent
• 3 years+ of experience in the Life Sciences industry (pharmaceutical, biotechnology or CRO experience preferred)
• Document management/TMF related industry experience in order to have a thorough understanding of the processes associated with the conduct of clinical trials and document management operations
• International Council for Harmonization (ICH)/GCP knowledge and understanding
• Experience working with eTMF or other eClinical systems such as Veeva Vault or Wingspan IQVIA TMF

Desired Skills & Experience

• Good interpersonal skills
• Ability to build relationships with clients and co-workers

Where Your Career Is Going:

At TransPerfect, there are a lot of growth opportunities. All departments offer career growth and development that can combine your skills, interest and experience. We encourage our employees to have a continuous dialogue with management about growth oppportuinties throughout your tenure with the company.

End your job search and find your career at TransPerfect #careersNOTjobs.

Why TransPerfect:

For more than 25 years, we have honed a culture where all kinds of ideas are shared and new ventures are not only welcomed, but also encouraged. In this fast-paced environment, employees are intellectually stimulated so they can grow alongside the organization. From Intern to President, we believe that every single employee should have a voice and contribute to the amazing services we offer our clients.

We also offer a comprehensive benefits package including medical, dental, and vision insurance, 401k matching, membership to child-care providers, and other TransPerks. You even get your birthday off because let's face it, we're stoked that you were born.

TransPerfect provides equal employment opportunity to all individuals regardless of their race, color, creed, religion, gender, age, sexual orientation, national origin, disability, veteran status, or any other characteristic protected by state, federal, or local law

For more information on the TransPerfect Family of Companies, please visit our website at www.transperfect.com.