TMF Specialist - Remote - FSP

When our values align, there's no limit to what we can achieve.
 
At Parexel, we all share the same goal - to improve the world's health. From clinical trials to regulatory, consulting, and market access, every clinical development solution we provide is underpinned by something special - a deep conviction in what we do.

Each of us, no matter what we do at Parexel, contributes to the development of a therapy that ultimately will benefit a patient. We take our work personally, we do it with empathy and we're committed to making a difference.

Parexel 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