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, this role will offer a fast-track route to becoming a Lead Data Manager.
  
• 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.
  

As a leading contract research organization (CRO), Labcorp Drug Development provides comprehensive drug development solutions for a range of industries. Our services cover the preclinical, clinical and post-market phases of drug development, the product life cycles for medical device and diagnostics and development services paired with regulatory support for the chemical testing and crop protection industries.

Labcorp Drug Development is a global leader in nonclinical safety assessment, clinical trial testing and clinical trial management services. Our unique perspectives are based on decades of scientific, medical and regulatory expertise.

Did you know?

In July 2022, Labcorp announced its intention to spin off its clinical development business as a separate public company, subject to the satisfaction of certain customary conditions. Fortrea will become the new brand identity for our Clinical Development business in connection with the spin-off, which is expected in mid-2023.

We believe that the exceptional is possible when you have the right partner, so we are looking for the right people to help build a transformative force in Clinical Development. www.fortrea.com

Labcorp is proud to be an Equal Opportunity Employer:

As an EOE/AA employer, Labcorp strives for diversity and inclusion in the workforce and does not tolerate harassment or discrimination of any kind. We make employment decisions based on the needs of our business and the qualifications of the individual and do not discriminate based upon race, religion, color, national origin, gender (including pregnancy or other medical conditions/needs), family or parental status, marital, civil union or domestic partnership status, sexual orientation, gender identity, gender expression, personal appearance, age, veteran status, disability, genetic information, or any other legally protected characteristic. We encourage all to apply.

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