Trial Master File Specialist - Junior / Senior - Poland - FSP

ABOUT THIS ROLE

At Parexel FSP, you will be joining a team with a wide variety of experiences and knowledge. We’re looking for people like you to take the initiative to do things better and smarter people who want to grow personally and professionally. We recognize and uphold the importance of all people, the way we do things, our quest for innovation, and most importantly, our patients.

We are looking for a TMF Specialist 100% home based in Poland.

Your tasks will be

• Perform Quality control activities process for TMF submissions to Veeva Vault (JV) eTMF in accordance with the documented process

• Carry out required activities in JV eTMF for all Clinical Vault/eTMF user access requests in accordance with the documented process

• Carry out required activities in JV eTMF for all requests for changes to be made to TMF documents in accordance with the documented process

• Member of the TMF Ops team that oversees the TMF Ops mailbox for all new TMF specific questions and requests, ensuring all requests are triaged to appropriate TMF Ops team members

• Support the development of study-specific, cross-departmental TMF Plans and TMF Indexes

• 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

• Support TMF process improvement activities as required

• Promote the use of eTMF with cross functional teams by building strong professional relationships and networks among peers and colleagues
• Support TMF Ops team activities in required TMF preparation for internal audits and/or Regulatory inspections
• Assist in mentoring and training of new staff and contractors as relevant to their role
• Support any other Business & Technology Capabilities project activities as required

Skills:

• Good communication skills

• Quality driven with a focus on attention to detail

• Flexible and adaptable to a fast-changing environment

• Good time management and organizational skills

• Good computer skills (Microsoft Office suite, SharePoint use)

• Ability to work independently and in a global team environment to support overarching TMF Ops team deliverables

Knowledge and Experience:

• Experience working in a TMF environment at a Sponsor or CRO company - at least 12 months.

• 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

Education:

• Educated to degree level or equivalent

Send your CV to [email protected]