Study Owner, eClinical Solutions

TransPerfect; City of London; On-site; GBP 35,000 - 50,000; Full time

Job summary

A leading clinical solutions company in the UK is seeking a Study Owner to manage Trial Master Files and ensure compliance with Good Clinical Practices. The ideal candidate will have a Bachelor's degree, 3+ years in the Life Sciences industry, and familiarity with electronic TMF systems. This is a full-time position with responsibilities across multiple studies to support clients and improve TMF operational efficiencies.

Qualifications

• 3 years+ of experience in Life Sciences industry.
• Document management/TMF related experience.
• Knowledge of ICH/GCP processes.

Responsibilities

• Manage TMF across multiple studies and programs.
• Support inspection readiness and compliance.
• Create study-specific TMF Plans.

Skills

Superior written and spoken communication skills in English

Ability to multitask

Proactive and self-initiated

Exceptional problem-solving skills

Detail-oriented and organized

Education

Bachelor’s degree or equivalent

Tools

Veeva Vault

Wingspan IQVIA TMF

Job description

Apply for the Study Owner, eClinical Solutions role at TransPerfect.

The Study Owner (SO) is part of TransPerfect’s Trial Interactive division within the Client Services team, serving as an extension to clients’ study teams. The SO ensures a complete, contemporary, and accurate Trial Master File (TMF) and electronic TMF (eTMF) across clients’ clinical programs, focusing on study start‑up and TMF management to support inspection readiness.

Responsibilities

• 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
• Ensure compliance with client Standard Operating Procedures (SOPs) and work instructions
• Meet with study teams to understand events/activities that would impact the TMF
• 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

Essential skills required

• Superior written and spoken communication skills in English (written and verbal)
• Ability to effectively multitask in order to simultaneously execute multiple projects
• Proactive and able to work on own initiative
• Exceptional problem‑solving/critical‑thinking skills
• Detail‑orientated and well organized

Required experience and qualifications

• Bachelor’s degree or 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 Harmonisation (ICH)/GCP knowledge and understanding
• Experience working with eTMF or other eClinical systems such as Veeva Vault or Wingspan IQVIA TMF

Desired skills and experience

• Good interpersonal skills
• Ability to build relationships with clients and co‑workers
• Knowledge of additional languages at professional working proficiency

Seniority level

• Associate

Employment type

• Full‑time

Job function

• Consulting, Information Technology, and Strategy/Planning

Industries

• Translation and Localization, Technology, Information and Media, and Business Consulting and Services

TransPerfect provides equal employment opportunities 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 local law.

We celebrate diversity as one of our core values and we have a clear goal: to be an inclusive workplace where a diverse mix of talented people want to come, stay and do their best work. Together with passionate, creative and collaborative colleagues, we are working to ensure accessibility is for everyone.

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