[Hiring] Senior Clinical Data Manager @BeiGene

Role Description

The Senior Clinical Data Manager’s role is responsible for assigning and/or driving all aspects of the clinical trial data management activities, from study start up through database lock, and is responsible for the quality of all data reviewers’ deliverables.

• Supports and works closely with study lead data manager(s) for assigned clinical studies.
• Performs data cleaning/reconciliation activities as specified in company procedural documents and study-specific Data Management (DM) documents.
• Manages queries on assigned clinical studies.
• Generates and delivers reports to study team members.
• Supports external data reconciliation, in addition to serious adverse event reconciliation.
• Ensures laboratory data, if applicable, and associated lab normal ranges are reviewed and reconciled.
• Supports the creation and maintenance of DM documentation (e.g., Data Management Plans, eCRF Completion Guidelines).
• Helps to ensure DM documents are filed per company Standard Operating Procedures (SOP) and Work Instructions (WI).
• Supports eCRF and edit check specifications development as necessary to support data collection and analyses required by the protocol.
• May work closely with database builders during clinical database build and programming of eCRF, edit checks, and reports.
• Participates in User Acceptance Testing (UAT) activities for clinical database build and modifications.
• Participates in UAT activities for data transfers and programmed report outputs.
• Assists with Site and User management in clinical database of assigned clinical studies.
• May lead one or more Phase I to Phase II studies under supervision of manager.
• Will have the opportunity to drive all data review related activities, including identifying and escalating potential data issues to the Data Management Team when issues arise.
• May work with vendors such as central laboratories in support of timelines and data-related deliverables.
• May help identify and troubleshoot operational problems, issues, obstacles, and barriers for studies based on metrics data, audit reports, and input from other project team members.
• May help train other personnel on eCRFs and EDC.
• May help support development and maintenance of SOP and WI related to data management activities.
• Other duties as assigned.

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 for ICH and regulatory environment as it pertains to data management.
• Good understanding of data management knowledge and phases of clinical trials.
• Strong communications skills and capable of solving issues independently.
• Strong project management skills.
• Excellent written, verbal and organizational skills.
• Good interpersonal skills and have the capability to lead studies DR(s) and prioritize DM activities.
• Must be detail-oriented.

Requirements

• Proficient computer skills, including Microsoft Office applications.
• Working knowledge of at least one EDC system, Medidata Rave is preferred.

Travel

• Travel may be required as per business need, ability to travel domestically and internationally.

Education Required

• Bachelor’s degree or equivalent in a health-related field preferred.

Benefits

• Comprehensive benefits package includes Medical, Dental, Vision, 401(k), FSA/HSA, Life Insurance, Paid Time Off, and Wellness.
• Eligible for discretionary equity awards and to voluntarily participate in the Employee Stock Purchase Plan.

Salary Range

$108,700.00 - $143,700.00 annually. Actual compensation packages are determined by several factors unique to each candidate.