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Associate Clinical Data Manager - Early Phase

Employer
Labcorp
Location
Leeds, United Kingdom
Salary
Competitive
Start date
24 Sep 2022
Closing date
26 Sep 2022

View more

Discipline
R & D , Bioinformatics
Hours
Full Time
Contract Type
Permanent
Experience Level
Experienced (non-manager)

Job Details

Associate Clinical Data Manager - Early Phase

Description
  • You will be permanently employed by Labcorp Drug Development working in our Clinical Development Services (CDS) division working across a wide range of Sponsors and multiple therapeutic areas in Phases I to IIa.
  • Office based or home based anywhere in Europe or South Africa.
  • You must have previous experience of working in a clinical data management role within clinical research and ideally demonstrate some lead experience.
  • Candidates must be fluent in English language (both verbal and written).


Join our growing team and discover your extraordinary potential by working as an Associate Clinical Data Manager within our Global Early Development department. The CDS department works across multiple therapeutic areas in Phases I to IIa with multiple Sponsors. The position offers a strong support network, flexible working solutions and the opportunity to progress your career.

If you are looking to strengthen your expertise within a varied and dynamic environment, then this is a fantastic opportunity.

In this role, you will:
  • Assist and lead operations team alongside Senior CDM, develop project documentation, system setup, data validation processes and procedures assigned to junior staff.
  • As a lead data reviewer, you will perform all data operational tasks, ensuring quality standards are maintained.
  • Work with Senior CDM to build study milestone timelines and be able to read and follow study timelines for on-time deliverables.
  • Assist or lead internal and external DM meetings.
  • Assist or lead to write, update/review and approve all required trial data documentation, including: Study-specific case report forms, CRF completion guidelines, DMP and Data Quality checks.
  • Ensures study specific data transfer agreements are in place for all data vendors involved.
  • Track scope changes and work with Senior CDM to ensure Sponsor approval is received and the scope change processed.
  • Assist in the training of new staff on project specific DM processes.
  • Coordinate with the DM study team to ensure all data related information is delivered within agreed timelines.
  • Ensure all appropriate documentation and procedures are performed upon project completion for operations team.
  • Attend client or internal audits as required and address client comments with the study team.
  • Assist with the completion of Database Lock and Unlock activities with the Senior CDM.


Education
  • University/college degree (life science, pharmacy or related subject preferred), or certification in a related allied health profession from an appropriately accredited institution (e.g., nursing certification, medical or laboratory technology).
  • Additional relevant work experience will be considered in lieu of formal qualifications.

Experience
  • Experience in clinical data management as a Lead DM or Senior CDA or similar within early phase trials.
  • Excellent oral and written communication and presentation skills.
  • In depth knowledge of clinical trial process and data management, clinical operations, biometrics, quality management, and systems applications to support operations.
  • Working knowledge of the relationship and regulatory obligation of the CRO industry with pharmaceutical / biotechnological companies.


MORE INFORMATION AVAILABLE ON REQUEST

Keywords:

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Labcorp is proud to be an Equal Opportunity Employer:

As an EOE/AA employer, the organization will not discriminate in its employment practices due to an applicant's race, age, color, religion, sex, national origin, sexual orientation, gender identity, disability or veteran status.

For more information about how we collect and store your personal data, please see our Privacy Statement .

Company

At Labcorp, we believe in the power of science to change lives. We are a leading global life sciences company that delivers answers for crucial health questions —because we know that knowledge has the potential to make life better for all. Through our unparalleled diagnostics and drug development capabilities, we provide insights and accelerate innovations that not only empower patients and providers but help medical, biotech, and pharmaceutical companies transform ideas into innovations. Here, you can join our more than 70,000 employees, serving clients in more than 100 countries, as we work together to make a real impact on people’s lives. Join us in our pursuit of answers.

 

 

 

 

Company info
Website
Location
Maidenhead Office Park
Westacott Way
Littlewick Green
Maidenhead
SL6 3QH
United Kingdom

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