Associate Clinical Data Manager at Labcorp Drug Development

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.