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Experience Level
Experience
Qualifications
To excel in this role, candidates should have a background in clinical project management or a related field, with a strong understanding of TMF and eTMF systems. Attention to detail, excellent organizational skills, and the ability to work collaboratively are essential. Familiarity with GCP regulations and inspection readiness practices will be advantageous.
About the job
As a Study Owner (SO) within the Client Services team at TransPerfect's Trial Interactive division, you will act as an integral part of our clients' study teams. Your primary responsibility is to ensure the integrity, accuracy, and contemporaneity of the Trial Master File (TMF) and electronic TMF (eTMF) for our clients' clinical initiatives. Collaborating closely with client study teams and functional leads, you will play a critical role in managing studies with a strong emphasis on study start-up and TMF management to ensure readiness for inspections.
Key Responsibilities:
Engage with clients as a Study Owner, consistently delivering exceptional customer satisfaction.
Take ownership of the TMF on behalf of clients across multiple studies and programs.
Foster a culture of inspection readiness and ensure compliance with Good Clinical Practices (GCP).
Support study teams in maintenance and close-out activities using systems such as CTMS and eTMF.
Develop study-specific TMF Plans for clients.
Ensure compliance with TMF plans and client Standard Operating Procedures (SOPs).
Coordinate meetings with study teams to identify events and activities that may impact the TMF.
Manage eTMF user access and permissions continuously.
About TransPerfect
TransPerfect is a leading provider of globalization services, offering a comprehensive range of solutions to help clients navigate the complexities of clinical trials. Our Trial Interactive division is dedicated to supporting clients in achieving their research goals with high-quality, efficient processes.
Study Owner in eClinical Services
TransPerfectLondon, Greater London, United KingdomNew
Clicking Apply Now takes you to AutoApply where you can tailor your resume and apply.
Unlock Your Potential
Generate Job-Optimized Resume
One Click And Our AI Optimizes Your Resume to Match The Job Description.
Is Your Resume Optimized For This Role?
Find Out If You're Highlighting The Right Skills And Fix What's Missing
Experience Level
Experience
Qualifications
To excel in this role, candidates should have a background in clinical project management or a related field, with a strong understanding of TMF and eTMF systems. Attention to detail, excellent organizational skills, and the ability to work collaboratively are essential. Familiarity with GCP regulations and inspection readiness practices will be advantageous.
About the job
As a Study Owner (SO) within the Client Services team at TransPerfect's Trial Interactive division, you will act as an integral part of our clients' study teams. Your primary responsibility is to ensure the integrity, accuracy, and contemporaneity of the Trial Master File (TMF) and electronic TMF (eTMF) for our clients' clinical initiatives. Collaborating closely with client study teams and functional leads, you will play a critical role in managing studies with a strong emphasis on study start-up and TMF management to ensure readiness for inspections.
Key Responsibilities:
Engage with clients as a Study Owner, consistently delivering exceptional customer satisfaction.
Take ownership of the TMF on behalf of clients across multiple studies and programs.
Foster a culture of inspection readiness and ensure compliance with Good Clinical Practices (GCP).
Support study teams in maintenance and close-out activities using systems such as CTMS and eTMF.
Develop study-specific TMF Plans for clients.
Ensure compliance with TMF plans and client Standard Operating Procedures (SOPs).
Coordinate meetings with study teams to identify events and activities that may impact the TMF.
Manage eTMF user access and permissions continuously.
About TransPerfect
TransPerfect is a leading provider of globalization services, offering a comprehensive range of solutions to help clients navigate the complexities of clinical trials. Our Trial Interactive division is dedicated to supporting clients in achieving their research goals with high-quality, efficient processes.