Other Locations:US- CA- San Diego- Science Park
Celgene is a global biopharmaceutical company leading the way in medical innovation to help patients live longer, better lives. Our purpose as a company is to discover and develop therapies that will change the course of human health. We value our passion for patients, quest for innovation, spirit of independence and love of challenge. With a presence in more than 70 countries, and growing - we look for talented people to grow our business, advance our science and contribute to our unique culture.
Responsible for supporting CDM and cross functional study teams as well as CROs to ensure delivery of high-quality clinical trials data for analysis. This individual will provide oversight, review data, and ensure a focus on timely and quality delivery and consistency across Data Management components within a particular development program or study. The Principal Data Manager participates in the oversight and review of clinical data management plans, and other study related documentation. Oversees the work of CROs that are performing Data Management tasks and supports program and leads as needed. May travel up to 10%.
- Provide oversight and support of CDM deliverables within a study/program
- Study level coordination and day to day oversight of CDM tasks including:
- May function as lead CDM within a study or program
- Review all CDM documents within a study area to ensure a consistent approach
- Review of study timelines and metrics to ensure databases are delivered to set timelines
- Support database locks
- Ensuring that quality control checks are occurring such that quality databases are delivered
- Coordinates/leads User Acceptance Testing as applicable
- Coordinates/leads SAE reconciliation
- Supports review and reconciliation of external data
- Leads database lock activities: inclusive of final SAE reconciliation/final data review, study decommission, etc.
- Lead/participate in regular team/cross functional meetings and provide input when appropriate
- Provide input and assist in review/adherence to project timelines
- Ensure quality & relevance when reviewing data listings from data management systems to support cross functional and medical monitor review
- Support the Sr. Manager, Associate Director, and Director CDM in the oversight of CROs for outsourced studies
- Ensures proper archival of all CDM documents at Receptos
- Ensure a constant state of inspection readiness & compliance
- Ensure study specific data transfer specifications in support of clinical data transfers are in place
- Proactively defines needed metrics, identifies trends in data that impact measured activities and makes recommendations for adjustments based on these trends
- Support other Biometrics groups as needed for QC, review, etc. to help ensure quality data
- Other responsibilities as assigned.
- Play a key role in meeting cross-functional goals through commitment, quality standards, and a customer service orientation.
- Contribute to a work environment that fosters professionalism, mutual respect, teamwork, and collaboration.
- Proficient in writing and updating functional SOPs/Working Procedures/Guidance Documents
- Ensure departmental companion groups (Programming, Coding, etc.) are consulted appropriately on study decisions
- Identify areas for improvement within department to gain efficiencies
Celgene is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability or veteran status. Celgene complies with all applicable national, state and local laws governing nondiscrimination in employment as well as employment eligibility verification requirements of the Immigration and Nationality Act. All applicants must have authorization to work for Celgene in the U.S.