Project Data Manager

BeOne Medicines Ltd.; Emeryville (CA); On-site; USD 110,000 - 160,000; Full time

Job summary

BeOne Medicines Ltd. in Emeryville, CA is seeking a Project Data Management lead to oversee the full data management lifecycle for multiple clinical studies, from startup through database lock and CSR support.

This role requires strong project management, attention to detail, and collaboration across functions, including statistics, safety, and medical writing. This role entails supervising data managers, coordinating with CRO/FSP resources, ensuring data quality and timely delivery, and driving

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.

Responsibilities

• Lead studies within a program and oversee data managers on studies in-house or CRO/FSP resources.
• Serve as active member of Clinical Study Teams and collaborate with functions to develop timelines.
• Define data transfer specifications and coordinate with external vendors to meet deliverables.
• Ensure data cleaning activities as per Data Management Plan and reviews of lab data against normal ranges.
• Develop or oversee eCRF completion guidelines and data management documents.
• Perform UAT for database builds and modifications and coordinate with programming of EDC databases.
• Mentor junior Clinical Data Managers and oversee oversight of data review activities.

Skills

Project management

Cross-functional teamwork

Attention to detail

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 the support on the studies are sufficient.
• Collaborates with program lead and other functions to ensure program-consistent, highquality 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.