Senior Clinical Data Manager — Lead Data & Study Delivery

BeOne Medicines; Emeryville (CA); On-site; USD 120,000 - 180,000; Full time

Job summary

BeOne Medicines is seeking a Senior Clinical Data Manager to lead and drive all data management activities from study start-up through database lock, ensuring the quality of all data reviewers’ deliverables. Responsibilities include supporting study leads, data cleaning, managing queries, generating reports, and maintaining DM documentation such as Data Management Plans and eCRF guidelines.

Travel may be required domestically and internationally.

Qualifications

• 5+ years of experience in clinical data management in the pharmaceutical/biotechnology industry
• Oncology experience preferred
• Ability to work in cross-functional team-oriented environments
• Understanding of ICH and regulatory environment as it pertains to data management
• Strong communications skills and project management

Responsibilities

• Supports and works closely with study lead data manager(s) for assigned clinical studies.
• Performs data cleaning/reconciliation activities per DM documents.
• Manages queries on assigned clinical studies.
• Generates and delivers reports to study team members.
• Supports external data reconciliation including SAE reconciliation.
• Ensures laboratory data, if applicable, is reviewed and reconciled.
• Maintains DM documentation (Data Management Plans, eCRF Completion Guidelines).
• Helps ensure DM documents are filed per SOPs and WI.
• Supports eCRF and edit check specs development for data collection and analyses.
• May work with database builders during clinical database build and UAT.
• Assists with Site and User management in clinical database of studies.
• May lead Phase I to Phase II studies under supervision.
• Mentors other team members on eCRFs and EDC.
• May help develop and maintain SOP/WI related to data management.

Job description

BeOne Medicines is seeking a Senior Clinical Data Manager to lead and drive all data management activities from study start-up through database lock, ensuring the quality of all data reviewers’ deliverables. Responsibilities include supporting study leads, data cleaning, managing queries, generating reports, and maintaining DM documentation such as Data Management Plans and eCRF guidelines.

Travel may be required domestically and internationally.