Jobs at Parexel
Are you ready to make your mark in the healthcare industry using your ingenuity and technical expertise? At Parexel, there's no limit to what you can accomplish. We work with the top 50 global pharmaceutical companies, the top global biotech companies, and hundreds of small and emerging companies. We've supported the development of some of the most important treatments of our time, including nearly all of the 50 top selling drugs currently on the market. Join us and you'll make a profound difference in millions of lives. With a role in our Information Technology group, you'll work with cutting-edge technology on internal and client-facing projects. Collaborating with people from all over the world and touching everything from enterprise systems and clinical applications to infrastructure and networking, you'll keep our data safe and confidential. You'll have the chance to develop your skills and pursue advancement opportunities that include managerial and technical tracks. If you have stellar coding and design experience and a passion to learn more about healthcare, Parexel invites you to discover our rewarding opportunities in Enterprise Architecture, Software Development, Project Management and Business Analysis, and more. In a global clinical trial environment, business-focused applications, connectivity, and data security are critical to a trial's outcome. Find out how you can be an invaluable part of our success story.
TMF Specialist - Remote - FSP
Job ID R0000034171 , ItalyParexel are currently recruiting for multiple Trial Master File Specialists (TMF Specialists) to support a key sponsor in EMEA, we are recruiting both Junior and Senior TMF Specialists.
In this position you will be an invaluable resource, providing support to colleagues cross functionally within the clinical study teams to maintain a complete and contemporaneous and high quality TMF.
Some specifics about this advertised role
- Perform Quality control activities process for TMF submissions to Veeva Vault eTMF in accordance with the documented process
- Carry out required activities in eTMF for all Clinical Vault/eTMF user access requests in accordance with the documented process
- Carry out required activities in eTMF for all requests for changes to be made to TMF documents in accordance with the documented process
- Support TMF health activities at a global level including generating TMF-relevant metrics from the eTMF system and escalating as necessary
- Support the development and delivery of a high standard training for the eTMF system and documented TMF process
Who are Parexel
Parexel supports clinical studies across the full range of therapeutic areas, and we have longstanding partnerships with a vast client base.
We supported the trials of most of today’s top 50 best-selling drugs, but equally we enable more niche drug developments that are critical to the well-being of many patients.
You’ll be an influential member of the wider team.
What we are looking for in this role
For every role, we look for professionals who have the determination and courage always to put patient well-being first.
That to us is working with heart.
Here are a few requirements specific to this advertised role.
- BS/ BA degree is preferred.
- Experience working in a TMF environment at a Sponsor or CRO company
- Current knowledge of Trial Master File Regulations and TMF Reference Model
- Previous experience working in an eTMF system (preferably Veeva Clinical Vault) as an end user, business, or system administrator
- TMF Specialists can be staffed at Junior or Senior level
- Senior level positions require five or more years of relevant experience as assessed by the client
#LI-REMOTE
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