Project Data Manager

BeOne Medicines; United States; On-site; USD 123,000 - 163,000; Full time

Benefits offered by this job

Medical

Dental

Vision

401(k)

FSA/HSA

Life Insurance

Paid Time Off

Wellness

Job summary

BeOne Medicines is seeking an experienced Clinical Data Manager to oversee data management for oncology studies. You will lead data managers, participate in Clinical Study Teams, and ensure on-time data delivery through collaboration with CROs and internal teams.

The role requires 6+ years in CDM, SDTM/CDASH experience, and strong project management abilities. Travel may be required; a comprehensive benefits package is provided.

Qualifications

• 6+ years of experience in clinical data management in pharma/biotech.
• Oncology experience preferred.
• Strong cross-functional collaboration in team settings.
• Understanding of ICH/regulatory requirements as they pertain to data management.
• Experience with SDTM/CDASH.
• Excellent project management and organizational skills.
• Detail-oriented with strong written and verbal communication.

Responsibilities

• Lead studies within a program and oversee data managers.
• Act as an active member of Clinical Study Teams.
• Collaborate with functions to meet data delivery timelines.
• Define data transfer specs and work with external vendors.

Skills

Clinical Data Management

Project Management

Cross-Functional Collaboration

Regulatory Knowledge

Attention to Detail

Excellent Communication

Education

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

Tools

Medidata Rave

Job description

• related deliverables.

Education Required

Bachelor’s degree or

BeOne continues to grow at a rapid pace with challenging and exciting opportunities for experienced professionals. When considering candidates, we look for scientific and business professionals who are highly motivated, collaborative, and most importantly, share our passionate interest in fighting cancer.

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 the 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

Global Competencies

• Fosters Teamwork
• Provides and Solicits Honest and Actionable Feedback
• Self-Awareness
• Acts Inclusively
• Demonstrates Initiative
• Entrepreneurial Mindset
• Continuous Learning
• Embraces Change
• Results-Oriented
• Analytical Thinking/Data Analysis
• Financial Excellence
• Communicates with Clarity

Salary Range: $123,200.00 - $163,200.00 annually

BeOne is committed to fair and equitable compensation practices. Actual compensation packages are determined by several factors that are unique to each candidate, including but not limited to job-related skills, depth of experience, certifications, relevant education or training, and specific work location. Packages may vary by location due to differences in the cost of labor. The recruiter can share more about the specific salary range for a preferred location during the hiring process. Please note that the listed range reflects the base salary or hourly range only. Non-Commercial roles are eligible to participate in the annual bonus plan, and 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 and to voluntarily participate in the Employee Stock Purchase Plan. The Company has a comprehensive benefits package that includes Medical, Dental, Vision, 401(k), FSA/HSA, Life Insurance, Paid Time Off, and Wellness.

• Medical
• Dental
• Vision
• 401(k)
• FSA/HSA
• Life Insurance
• Paid Time Off
• Wellness

We are proud to be an equal opportunity employer. BeOne does not discriminate on the basis of race, religion, color, sex, gender identity, sexual orientation, age, disability, national origin, veteran status or any other basis covered by appropriate law. All employment is decided on the basis of qualifications, merit, and business need. In order to ensure reasonable accommodation for individuals protected by Section 503 of the Rehabilitation Act of 1973, the Vietnam Era Veterans’ Readjustment Assistance Act of 1974, Title I of the Americans with Disabilities Act of 1990, and any other applicable federal, state or local laws, applicants who require reasonable accommodation in the job application process may contact [e-mail].