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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 global health 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 Slough employer: TransPerfect
Contact Detail:
TransPerfect Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land Study Owner, eClinical Solutions in Slough
✨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 processes and GCP regulations. Be ready to discuss how your experience aligns with the responsibilities of the role, especially around study start-up and compliance.
✨Tip Number 3
Showcase your problem-solving skills during interviews. Think of specific examples where you've tackled challenges in document management or improved operational efficiencies. This will demonstrate your proactive approach and 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 TransPerfect and contributing to our mission.
We think you need these skills to ace Study Owner, eClinical Solutions in Slough
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 any relevant skills that match the job description. We want to see how you fit into our team!
Show Off Your Communication Skills: Since this role requires superior written and spoken communication skills, don’t hold back! Use clear and concise language in your application. We love a good story, so feel free to share examples of how you've effectively communicated in past roles.
Highlight Your Problem-Solving Abilities: We’re looking for someone who can think critically and solve problems. In your application, mention specific instances where you’ve tackled challenges in your previous roles, especially related to TMF or clinical trials. This will show us you’re proactive and ready to take initiative!
Apply Through Our Website: Don’t forget to submit your application through our website! It’s the best way for us to receive your details and ensures you’re considered for the role. Plus, it shows you’re keen on joining our awesome team at TransPerfect!
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 managed TMFs 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 navigated complex conversations or resolved issues in the past. Practice articulating your thoughts clearly and confidently.
✨Demonstrate Problem-Solving Prowess
Be ready to tackle hypothetical scenarios related to TMF management or study start-up activities. Think about challenges you've faced and how you approached them. Highlight your critical thinking skills and your ability to find solutions under pressure.
✨Prepare for Questions on Compliance and Quality
Expect questions about compliance with client Standard Operating Procedures (SOPs) and how you ensure quality in your work. Have specific examples ready that illustrate your attention to detail and your commitment to maintaining high standards in clinical trials.
