At a Glance
- Tasks: Manage clinical trial documentation and ensure compliance for multiple studies.
- Company: Join TransPerfect’s innovative Trial Interactive division, part of a dynamic Client Services team.
- Benefits: Competitive salary, professional development, and opportunities to work on impactful projects.
- Other info: Collaborative environment with opportunities for growth and learning.
- Why this job: Be at the forefront of clinical trials and make a difference in healthcare.
- Qualifications: Bachelor’s degree and 3+ years in Life Sciences or document management experience.
The predicted salary is between 40000 - 50000 £ per year.
The Study Owner (SO) forms part of the Client Services team within TransPerfect’s Trial Interactive division, working on behalf of clients as an extension to their study team. The Study Owner ensures a complete, contemporaneous and accurate Trial Master File (TMF) and electronic TMF (eTMF) across our clients’ clinical programs. Working with client study teams and functional leads, they assume a key role in the management of a study with a focus on study start up and the TMF with the goal of supporting inspection readiness.
Position 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.
- Help ensure TMF plan compliance.
- Ensure compliance with client Standard Operating Procedures (SOPs) and work instructions.
- Meet with study teams to understand events/activities that would impact the TMF.
- eTMF ongoing user management.
- 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).
- Strong presentation skills.
- 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 organised.
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.
Study Owner, eClinical Services employer: TransPerfect
TransPerfect’s Trial Interactive division is an exceptional employer, offering a dynamic work culture that prioritises collaboration and innovation in the Life Sciences sector. Employees benefit from comprehensive training and development opportunities, ensuring continuous professional growth while working in a supportive environment that values compliance and quality. Located in a vibrant area, the company fosters a strong sense of community and encourages a proactive approach to career advancement, making it an ideal place for those seeking meaningful and rewarding employment.
StudySmarter Expert Advice🤫
We think this is how you could land Study Owner, eClinical Services
✨Tip Number 1
Network like a pro! Reach out to people in the industry, especially those who work at TransPerfect or similar companies. A friendly chat can open doors and give you insights that job descriptions just can't.
✨Tip Number 2
Prepare for interviews by practising common questions related to TMF and eClinical services. We recommend role-playing with a friend or using online resources to get comfortable with your answers.
✨Tip Number 3
Showcase your problem-solving skills during interviews. Think of examples from your past experience where you tackled challenges in clinical trials or document management. This will demonstrate your critical thinking abilities!
✨Tip Number 4
Don’t forget to apply through our website! It’s the best way to ensure your application gets noticed. Plus, it shows you're genuinely interested in joining our team at StudySmarter.
We think you need these skills to ace Study Owner, eClinical Services
Some tips for your application 🫡
Tailor Your CV:Make sure your CV is tailored to the Study Owner role. Highlight your experience in document management and clinical trials, and don’t forget to showcase your communication skills – they’re key for this position!
Craft a Compelling Cover Letter:Your cover letter is your chance to shine! Use it to explain why you’re passionate about the role and how your background aligns with the responsibilities listed. Be genuine and let your personality come through.
Showcase Relevant Experience:When filling out your application, focus on your relevant experience in the Life Sciences industry. Mention specific projects or roles where you’ve managed TMFs or worked with eClinical systems – this will grab our attention!
Apply Through Our Website:We encourage you to apply directly through our website. It’s the best way to ensure your application gets into the right hands. Plus, it shows you’re proactive and keen to join our team!
How to prepare for a job interview at TransPerfect
✨Know Your TMF Inside Out
Make sure you understand the Trial Master File (TMF) and electronic TMF (eTMF) processes thoroughly. Brush up on your knowledge of Good Clinical Practices (GCP) and be ready to discuss how you’ve managed TMFs in previous roles. This will show that you’re not just familiar with the terms, but you can also apply them effectively.
✨Showcase Your Communication Skills
Since this role requires superior written and spoken communication skills, prepare to demonstrate these during the interview. Think of examples where you’ve successfully communicated complex information to clients or team members. Practising your responses out loud can help you articulate your thoughts clearly.
✨Be Ready to Multitask
The ability to multitask is crucial for this position. Prepare to discuss specific instances where you’ve juggled multiple projects or responsibilities. Highlight your organisational skills and any tools or methods you use to keep everything on track, as this will resonate well with the interviewers.
✨Emphasise Problem-Solving Skills
This role involves identifying and resolving TMF issues, so be prepared to share examples of challenges you’ve faced in past positions and how you overcame them. Focus on your critical thinking abilities and how you approach problem-solving, as this will demonstrate your proactive nature and readiness for the role.
