TMF Inspection Readiness Specialist - FSP

Key Accountabilities:

 Oversight of activities

• Perform Quality control activities process for TMF submissions to Jazz 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 Jazz 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  

Collaborative relationships 

• Supports multiple TMF Operations activities and projects and will identify issues and escalate as needed to TMF Ops leads, promoting TMF inspection readiness and TMF best practices.  

Compliance with Parexel standards 

• Complies with required training curriculum   

• Completes timesheets accurately as required   

• Submits expense reports as required   

• Updates CV as required   

• Maintains a working knowledge of and complies with Parexel processes, ICH-GCPs and other applicable requirements   

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   

• 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  

Parexel are currently recruiting a Trial Master File (TMF) specialist. This role can be based in Poland, Czech Republic, Hungary, Spain or South Africa.

In this role, the TMF Specialist works closely with Business & Technology Capabilities colleagues to support cross functional clinical study teams to maintain a complete and contemporaneous and high quality TMF. The TMF Specialist will demonstrate a good understanding of TMF processes and awareness of evolving regulatory requirements related to records management to support the development and delivery of TMF Operations strategy.

This will be a fully remote home-based position.

Key Accountabilities:

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

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

• Carry out required activities in VV 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 VV 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 new staff and contractors as relevant to their role.

• Support any other Business & Technology Capabilities project activities as required.

• Supports multiple TMF Operations activities and projects and will identify issues and escalate as needed to TMF Ops leads, promoting TMF inspection readiness and TMF best practices.

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.

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.

• Strong IT skills (Microsoft Office suite, SharePoint).

• 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 in a pharmaceutical company or CRO.

• 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.

Education:

• Bachelor’s degree or equivalent.