Project Data Manager

BeOne Medicines; San Mateo (CA); On-site; USD 110,000 - 170,000; Full time

Job summary

BeOne Medicines seeks a Clinical Data Manager to oversee data management for multiple oncology studies from startup to database lock, ensuring high quality deliverables and resource efficiency.

You will lead data managers, coordinate with CROs/FSPs, develop eCRF/edit-check specifications, drive UAT, create data management plans, and ensure regulatory compliance and timely data delivery. This role also involves mentoring junior staff and collaborating across cross-functional teams.

Qualifications

• 6+ years of experience in clinical data management in the pharmaceutical/biotech industry.
• Oncology experience preferred.
• Experience with SDTM/CDASH.
• Understanding of ICH and regulatory environment as it pertains to data management.
• Strong project management skills.
• Excellent written, verbal and organizational skills.
• Must be detail-oriented.

Responsibilities

• Lead studies within a program.
• Oversee data managers on studies in-house or CRO/FSP resources.
• Serves as active member of Clinical Study Teams.
• Collaborates with other functions to develop timelines and ensure deadlines are met.
• Defines external data transfer specifications and works with external vendors.
• Ensures process to review and reconcile lab data with lab normal ranges.
• Develops eCRF and edit check specifications to support data collection and analyses.
• Works with database builders during programming of EDC databases, edit checks and reports.
• Drives User Acceptance Testing (UAT) for database builds and modifications.
• Develops or oversees study-specific eCRF Completion Guidelines and Data Management Plans.
• Creates and maintains data management documentation.
• Ensure data cleaning activities as specified in the Data Validation Specifications and Data Management Plan.
• Collaborates with coding group to ensure coding is applied to studies.
• Defines listings to support data management and reviews.
• Identifies and troubleshoots operational problems for studies.

Skills

Project management

Detail-oriented

Cross-functional teamwork

Communication skills

Education

Bachelor's degree in health-related field

Tools

Medidata Rave

Job description

General Description:

Project Data Management role is responsible for all aspects of the clinical trial data management process from study start up through database lock and support of clinical study report (CSR) activities for assigned studies. This role is also accountable for quality of deliverables and resource efficiency of assigned studies. This role may be expected to lead multiple clinical studies and/or oversee CRO/FSP vendors for multiple clinical studies.

Essential Functions of the Job:

• Lead studies within a program
• Oversee data managers working on studies either in-house or CRO/FSP resources
• Serves as active member of Clinical Study Teams.
• Collaborates with other functions to develop timelines and ensure that clinical data management deadlines are met.
• Defines external data transfer specifications and works with external vendors in support of timelines and data related deliverables.
• Ensures process is in place to review and reconcile lab data with lab normal ranges
• Develops or oversees development of eCRF and edit check specifications as necessary to support data collection and analyses required by the protocol.
• Works closely with database builders during programming of EDC databases, edit checks and reports.
• Drives and performs User Acceptance Testing (UAT) activities for clinical trial database build and modifications.
• Develops or oversees development of study-specific eCRF Completion Guidelines and Data Management Plans.
• Creates and maintains data management documentation.
• Ensure data cleaning activities as specified in the Data Validation Specifications and Data Management Plan.
• Works with coding group to ensure coding is applied to assigned clinical studies in conjunction with study timelines and deliverables.
• Defines listings in support of data management, clinical and medical review of data.
• Identifies and troubleshoots operational problems, issues, obstacles, and barriers for studies based on metrics data, audit reports, and input from other project team members.
• Will have the opportunity to drive all data review related activities. This will also include identifying and escalating potential data issues to LDM when issues arise.
• Trains other personnel on eCRFs and EDC, as needed.
• Ensures coordination with Pharmacovigilance on serious adverse event reconciliation.
• Reviews and provides feedback on draft protocols, Statistical Analysis Plans, CSRs and other documents as required.
• Support management team with continued process improvement/innovation for the department and participates in the development and maintenance of Standard Operating Procedures (SOPs) and Work Instructions related to data management activities.
• Will oversee data managers working on studies either in-house or CRO/FSP resources to ensure studying support on the studies are sufficient.
• Collaborates with program lead and other functions to ensure program-consistent, high quality and on-time data delivery.
• May mentor other junior Clinical Data Managers.
• 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:

• 6+ 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
• Experience with SDTM/CDASH
• Strong project management skills
• Excellent written, verbal and organizational skills
• 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.