Sr. Data Mgr., Data Mgmt.

Clinical Dev

icon-location-marker Celgene - Berkeley Heights - NJ
icon-location-marker Princeton - NJ - US
Posted 45 days ago Full_time R1521463

Bristol-Myers Squibb is a global Biopharma company committed to a single mission: to discover, develop, and deliver innovative medicines focused on helping millions of patients around the world in disease areas such as oncology, cardiovascular, immunoscience and fibrosis.

 

Join us and make a difference.  We hire the best people and provide them with a work environment that places a premium on diversity, integrity, collaboration and personal development. Through a culture of inclusion, we create a better, more productive work environment. We believe that the diverse experiences and perspectives of all our employees help to drive innovation and transformative business results.

Summary/Scope

Lead data management activities in one or more studies, in accordance with applicable SOPs, WPs, guidelines and regulations.

Responsibilities

Provide CRO/Vendor oversight to end-to-end Data Management activities, manage data currency throughout the trial and overall monitoring DM deliverables according to the SLA such as but not limited to:

Participates in CRO selection

Completes Scope of Work (SOW) according to Study protocol requirements

Participates in project bid defense meetings

Review CRO bid grid

Participates in CRO/Vendor Project kick off meeting

Provides CRO oversight of the data management functional activities and monitor deliverables according to Service Level Agreement

Hands-on Data-Management activities for in-house Studies

Leads Data-Management activities during Study Start-up (Development of eCRF, Data-Management Plan, Data-Validation Plan, CRF Completion guidelines, Data Review Plan, External Data transfer Specifications), Study Maintenance (Data cleaning and Review, External Data Reconciliation, SAE reconciliation), Study Closure (Database Lock activities, Study decommissioning)

Additional activities

Support change management initiatives with broad impact as participant in initiatives, participate in developing and reviewing functional SOPs/WP/GD

Acts as DM Core Team Member to study teams, functional representative to Submission Teams and HA inspections and audits

Knowledge/Competencies Required

Solid understanding of FDA/ICH guidelines and industry standard practices regarding data management

Solid knowledge of submission requirements, [e.g. New Drug Application (NDA)/Biologics License Application (BLA)/Market Authorization Application (MAA)]

Expert knowledge and experience of EDC systems and related technologies (Medidata RAVE preferred); demonstrated knowledge of Microsoft Office skills

Possesses project management; Exhibits expertise in metrics analysis and reporting methodologies; ability to multitask

Excellent oral and written communication skills

Experience in managing Clinical trial data management activities, applying data management concepts, clinical trial data processing techniques, and integrating them with the entire clinical data operations

Good knowledge of therapeutic area

Ability to work individually, within a multi-disciplinary team, as well as with CROs and Vendors

Bristol-Myers Squibb recognizes the importance of balance and flexibility in our work environment. We offer a wide variety of competitive benefits, services and programs that provide our employees the resources to pursue their goals, both at work and in their personal lives.