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- Tasks: Manage clinical study documentation and ensure compliance for successful trials.
- Company: Join TransPerfect, a leader in eClinical solutions with a focus on innovation.
- Benefits: Competitive salary, diverse workplace, and opportunities for professional growth.
- Why this job: Be part of impactful clinical research and support life-changing medical advancements.
- Qualifications: Bachelor's degree and 3+ years in Life Sciences or related fields.
- Other info: Dynamic team environment that values diversity and inclusion.
The predicted salary is between 36000 - 60000 £ 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 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 Harmonization (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
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.
By applying, I confirm I have read and accept TransPerfect's Privacy Policy: Privacy Policy
Study Owner, eClinical Solutions in London employer: TransPerfect
Contact Detail:
TransPerfect Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land Study Owner, eClinical Solutions in London
✨Tip Number 1
Network like a pro! Reach out to your connections in the Life Sciences industry and let them know you're on the hunt for a Study Owner role. You never know who might have the inside scoop on job openings or can put in a good word for you.
✨Tip Number 2
Prepare for interviews by brushing up on your knowledge of TMF and eTMF systems. Be ready to discuss how your experience aligns with the responsibilities listed in the job description, especially around study start-up and compliance with GCP.
✨Tip Number 3
Showcase your problem-solving skills during interviews. Think of specific examples where you've tackled challenges in document management or clinical trials, and be prepared to share how you ensured inspection readiness.
✨Tip Number 4
Don't forget to apply through our website! It’s the best way to ensure your application gets seen by the right people. Plus, it shows you're serious about joining our team at TransPerfect.
We think you need these skills to ace Study Owner, eClinical Solutions in London
Some tips for your application 🫡
Tailor Your Application: Make sure to customise your CV and cover letter for the Study Owner role. Highlight your experience in document management and clinical trials, as well as your understanding of GCP regulations. We want to see how your skills align with what we're looking for!
Show Off Your Communication Skills: Since this role requires superior written and spoken communication, don’t hold back! Use clear and concise language in your application. We love seeing candidates who can express their thoughts effectively, so let your personality shine through!
Highlight Your Problem-Solving Abilities: We’re on the lookout for proactive individuals who can tackle challenges head-on. In your application, share examples of how you've resolved issues in past roles, especially in relation to TMF or eClinical systems. This will show us you’re ready to take on the responsibilities of the Study Owner.
Apply Through Our Website: We encourage you to submit your application directly through our website. It’s the best way to ensure it gets into the right hands. Plus, you’ll find all the details about the role and our company culture there, which can help you tailor your application even further!
How to prepare for a job interview at TransPerfect
✨Know Your TMF Inside Out
Make sure you have a solid understanding of the Trial Master File (TMF) and electronic TMF (eTMF) processes. Brush up on your knowledge of Good Clinical Practices (GCP) and be ready to discuss how you've applied these in previous roles.
✨Showcase Your Communication Skills
As a Study Owner, you'll need to communicate effectively with clients and study teams. Prepare examples of how you've successfully managed client relationships or resolved issues through clear communication. Practice articulating your thoughts clearly and confidently.
✨Demonstrate Problem-Solving Prowess
Be ready to share specific instances where you've identified and resolved TMF-related issues. Highlight your critical thinking skills and how you've contributed to continuous improvement in past roles. This will show that you're proactive and detail-oriented.
✨Prepare for Scenario-Based Questions
Expect questions that assess your ability to multitask and manage multiple projects simultaneously. Think of scenarios from your experience where you had to juggle various responsibilities and how you ensured compliance with SOPs and TMF plans.
