Senior Clinical Data Manager

BeOne Medicines; San Mateo (CA); On-site; USD 120,000 - 160,000; Full time

Job summary

BeOne Medicines seeks a Senior Clinical Data Manager to lead data management activities from study start-up to database lock, ensuring quality of all data reviewer deliverables.

The role partners with study leads, handles data reconciliation, manages DM documentation, and supports UAT and data transfers across trials, with travel as needed.

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
• Understanding of data management 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 ability to lead studies DRs and prioritize DM activities
• Detail-oriented

Responsibilities

• 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 studyspecific 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 review and reconciliation where applicable.
• Supports the creation and maintenance of DM documentation (e.g., Data Management Plans, eCRF Completion Guidelines).
• Helps to ensure DM documents are filed per SOPs and WI.
• Supports eCRF and edit check specifications development to support data collection and analyses.
• May work with database builders during clinical database build and programming of eCRF, edit checks, and reports.
• Participates in UAT for clinical database build, modifications, data transfers, and programmed outputs.
• Assists with Site and User management in clinical databases.
• May lead Phase I to Phase II studies under supervision.
• May train personnel on eCRFs and EDC and support SOP/WI development related to DM activities
• Other duties as assigned.

Skills

Communication skills

Project management

Written communication

Interpersonal skills

Cross-functional teamwork

Education

Bachelor’s degree or equivalent in health-related field

Tools

Microsoft Office

Medidata Rave

Job description

General 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.

Essential Functions of the job:

• 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 studyspecific 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. This will also include 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. This also includes mentoring other study team members when opportunities arise.
• 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.

Supervisory Responsibilities:

NA

Computer Skills:

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

Other 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 and good
• understanding of data management and phases of clinical trials
• Have a good understanding of data management knowledge and understands the 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

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

All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.