Note: The job is a remote job and is open to candidates in USA. BeOne is a rapidly growing organization focused on fighting cancer and advancing clinical research. The Project Data Manager oversees clinical trial data management from study start-up through database lock and clinical study report activities, ensuring quality, timelines, data cleaning, vendor coordination, and efficient delivery across assigned studies.
Responsibilities
- 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 oversees 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
Skills
- Proficient computer skills, including Microsoft Office applications
- 6+ years of experience in clinical data management in the pharmaceutical/biotechnology industry
- 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 may be required as per business need, ability to travel domestically and internationally
- Working knowledge of at least one EDC system, Medidata Rave is preferred
- Oncology experience preferred
- Bachelor's degree or equivalent in a health-related field preferred
Benefits
- Non-Commercial roles are eligible to participate in the annual bonus plan.
- Commercial roles are eligible to participate in an incentive compensation plan.
- All Company employees have the opportunity to own shares of BeOne Medicines Ltd. stock because all employees are eligible for discretionary equity awards.
- All employees are eligible to voluntarily participate in the Employee Stock Purchase Plan.
- Medical
- Dental
- Vision
- 401(k)
- FSA/HSA
- Life Insurance
- Paid Time Off
- Wellness
- Remote (US)
Company Overview