Manager, Clinical Data Management

Clinical Dev

icon-location-marker Celgene - Berkeley Heights - NJ
Posted 6 days ago Full_time R1518659

At Bristol Myers Squibb, we are inspired by a single vision – transforming patients’ lives through science. In oncology, hematology, immunology and cardiovascular disease – and one of the most diverse and promising pipelines in the industry – each of our passionate colleagues contribute to innovations that drive meaningful change. We bring a human touch to every treatment we pioneer. Join us and make a difference.

Responsibilities will include, but are not limited to:

Project Management and Leadership

  • Provides clinical data management leadership within the study team to  align on and drive  data collection requirements  for one or more complex clinical development projects
  • Efficiently plans, coordinates, and delivers complete, high quality and reliable clinical trial data in a timely manner for assigned projects
  • Responsible for end to end clinical data management activities and serves as a primary point of contact for internal and external  study team members with minimal oversight from senior data management resources
  •  Provides strong quality and project oversight  over third party vendor responsible for data management deliverables
  • Takes a leadership role to gather content and integration requirements for
  • EDC and close collaboration with partners supporting other data collection systems (eCOA, External Data, Safety Gateway). Enforces data standard conventions and quality expectations for clinical data per defined processes
  • Authors, reviews/revises DM related study plans including Data Quality Management Plan, Data Validation Plans, Data Review Plan, eCRF Completion Guidelines and other study documents to ensure quality and standardization
  • Chairs Data Quality Review meetings with cross functional study team members to ensure on-going review of trial data currency , quality and completeness
  • Represents DM on cross-functional project teams & submission Teams
  • Provides support to Health Authority inspections and audits
  • Authors, reviews/revises DM related study plans including Data Quality Management Plan, Data Validation Plans, Data Review Plan, eCRF Completion Guidelines and other study documents to ensure quality and standardization
  • Represents Data Management on cross-functional project teams
  • Support’s the Health Authority inspections and audits

FSP/CRO/Vendor Oversight

  • May act as core member of the study team and provides FSP/CRO/Vendor oversight for end-to-end Data Management activities, manages data currency throughout the trial, and overall monitoring DM deliverables according to the Service Level Agreement (SLA)

Degree Requirements

Bachelor’s Degree required

Experience Requirements

At least 3  years of relevant industry experience

Key Competency Requirements

  • Able to work collaboratively on multi-disciplinary project teams and develop productive relationships with external vendors
  • Sound knowledge of Clinical Drug Development Process, FDA/ICH guidelines and industry standard practices regarding data management
  • Strong knowledge and experience of EDC systems (Medidata RAVE preferred); demonstrated knowledge of Microsoft Office skills and well versed in industry trends and emerging technologies supporting data collection
  • Strong project management; Exhibits expertise in metrics analysis and reporting methodologies
  • Strong oral and written communication skills
  • Communicate effectively with senior management and cross-functional teams

Travel Required (nature and frequency). Enter “N/A” if not applicable.

Yes, 5-10% Industry Conferences, Investigator Meetings, Regulatory Inspections (as needed)

Around the world, we are passionate about making an impact on the lives of patients with serious diseases. Empowered to apply our individual talents and diverse perspectives in an inclusive culture, our shared values of passion, innovation, urgency, accountability, inclusion and integrity bring out the highest potential of each of our colleagues.

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 with the resources to pursue their goals, both at work and in their personal lives.