Associate Director, Clinical Data Management Princeton LVL - NJ R1602573 Posted hou

Position: Associate Director, Clinical Data Management Princeton LVL - NJ + 1 more R1602573 Posted 21 hou[...]
## Associate Director, Clinical Data Management Princeton LVL - NJFind out how well you match with this job
** Working with Us
** Challenging. Meaningful. Life-changing. Those aren’t words that are usually associated with a job. But working at Bristol Myers Squibb is anything but usual. Here, uniquely interesting work happens every day, in every department. From optimizing a production line to the latest breakthroughs in cell therapy, this is work that transforms the lives of patients, and the careers of those who do it.

You’ll get the chance to grow and thrive through opportunities uncommon in scale and scope, alongside high-achieving teams. Take your career farther than you thought possible.

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. Read more:
** Position Summary
** The Associate Director, Clinical Data Management is a leadership role considered essential to the sustainability and success of the BMS R&D pipeline.
** Key Responsibilities
*** 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
* May act as a driver to set program level data collection and review standards with cross functional team in partnership with global standards
* 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
* Lead or support the Health Authority inspections, audits, and CAPA implementation
* Provides coaching and quality oversight of junior Data Management Leads
* Lead or co-chair the department Data Management Lead forums

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)
* May act as a functional representative and a point of contact for CRO and preferred vendors

Continuous improvement initiatives
* Supports change management initiatives with broad impact as a lead or participant in initiatives, and/or authors (or participates in) functional SOPs/WP/GD
* Utilizes knowledge of data management processes to evaluate and recommend new technologies and systems for improved data management functionality
** 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…