Data Management Lead

Job Description

The Data Management Lead is responsible for monitoring study status, presenting deliverables to clients, gathering feedback, and proposing solutions. The role includes providing regular data status reports to the project team, overseeing the work of the Clinical Data Coordinator, and ensuring quality and timeliness of deliverables. The Data Management Lead will also oversee vendors to ensure timelines and deliverables meet sponsor and protocol requirements.

Key Responsibilities

• Ongoing maintenance of the clinical database, including data review and cleaning during study conduct and preparation for database lock/close.
• Conduct reconciliation between external data and data in the EDC system to ensure consistency, including reconciliation with sponsor safety databases for adverse events and serious adverse events (SAE) data.

Study Setup & Technical

• Develop the data management plan (DMP).
• Build a study-specific clinical database using the EDC system:
  • Design the electronic case report form (eCRF).
  • Build the clinical database independently or with the support of an EDC programmer.
• Coordinate the validation and user acceptance testing (UAT) of the clinical database.
• Support the study team with the development of external systems capturing clinical data (ePRO or IWRS), ensuring data transfer requirements are documented and tested.

User Training and Support

• Develop eCRF completion guidelines and other training materials.
• Conduct training for site users and monitors on the clinical database.
• Activate or deactivate new users in the clinical database upon request and maintain records.
• Respond to users requiring assistance with the EDC system.

Database Close/Lock

• Generate data listings and reports needed for data review in preparation for database close/lock.
• Ensure data management documentation is complete and up to date in the trial master file (TMF).
• Archive the clinical database and related documents.

Requirements

Education

B.Sc. or M.Sc. in a related field of study.

Experience

• 10 years of clinical data management experience in the pharmaceutical industry or a CRO environment.
• 5 years of experience as a lead data manager.
• Extensive experience working with EDC systems (experience with Medrio and Medidata Rave preferred).

Knowledge and Skills

• Highly organized and detail-oriented.
• Project planning and time management skills.
• Strong verbal and written communication skills in English.
• Understanding of the drug development process and applicable regulations, including Good Clinical Practices (GCP) and ICH Guidelines.
• Good understanding of CDISC SDTM/CDASH standards and knowledge of MedDRA and WHODrug dictionaries.

Please apply on the Lifelancer platform at the following link for screening steps and quicker responses:

Additional Information

Company Name: Lifelancer

Job Title: Clinical Data Manager - REMOTE