Other Locations:US- NJ- Berkeley Heights- 400
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.
Responsibilities will include, but are not limited to:
- Reviews synopsis/protocol and attends Synopsis Review Committee (SRC) meetings
- Leads DM study start-up and maintenance activities - CRF design/edit check specifications//external vendor specifications, CRF completion guidelines, (CCGs), coding, IVRS, etc.
- Leads development of site/investigator training materials and present at Investigator Meetings
- Leads Celgene team with User Acceptance Testing as applicable
- Leads SAE reconciliation
- Demonstrates ability to analyze data, share trends/observations with team members around results and relevant metrics
- Leads data review and query management
- Prepares the Data Management Plan and essential documentation
- Adheres to data standards and proper data validation processes
- Performs reconciliation of external data
- Leads database lock activities: inclusive of final SAE reconciliation/final data review, study decommission, etc.
- Lead/Participate in regular team meetings and provide input when appropriate
- Core study team member and primary contact for data management
- Provide input and assist in review/adherence to project timelines
- Provides oversight of vendor activities to ensure quality and timely deliverables
- Participates in CRO/external vendor selection
- Review Statement of Work (SOW)/contracts
- Provides CRO oversight of the data management functional activities and monitor progress and deliverables
- Ensures training on Celgene SOPs, if applicable
- Work is completed under minimal supervision; routine work may require little to no instruction
- Shows solid interpersonal skills and understanding of all project team functions to obtain necessary information from other project team members
- Working knowledge of EDC databases, preferably Medidata RAVE. Knowledge of J-Review or other reporting tool and basic understanding of SDTM and CDISC
- Strong written and oral communication skills
- Ability to work in a study team environment
- Intermediate knowledge of therapeutic area(s)
- Knowledge of FDA/ICH guidelines and industry standard practices regarding data management
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.