Associate Director, Clinical Data Management

Bristol Myers Squibb EU Policy · Princeton, NJ · 1 wk ago

Information Technology$171k–$207k/yrFull-time

About the role

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.

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.

Responsibilities

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 teams in partnership with global standards.
Provides strong quality and project oversight over third-party vendors 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, and 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 ongoing review of trial data currency, quality, and completeness.
Represents DM on cross-functional project teams and submission teams.
Leads or supports Health Authority inspections, audits, and CAPA implementation.
Provides coaching and quality oversight of junior Data Management Leads.
Leads or co-chairs the department Data Management Lead forums.
May act as a 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 of 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.
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.

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; expertise in metrics analysis and reporting methodologies.
Excellent oral and written communication skills.
Communicate effectively with senior management and cross-functional teams.
Knowledge of submission requirements, e.g., New Drug Application (NDA)/Biologics License Application (BLA)/Market Authorization Application (MAA).

Qualifications

Bachelor’s Degree in life sciences, data science, or statistics is required; an advanced degree is preferred.
7+ years of experience in Biopharma/CRO with 3+ years in a study/program leadership role.
Travel: 5-10% for industry conferences, internal and investigator meetings, and regulatory inspections (as needed).

Pay

Madison - Giralda - NJ - US: $170,800 - $206,968

The starting compensation range(s) for this role are listed above for a full-time employee (FTE) basis. Additional incentive cash and stock opportunities (based on eligibility) may be available. The starting pay rate takes into account characteristics of the job, such as required skills, where the job is performed, the employee’s work schedule, job-related knowledge, and experience. Final, individual compensation will be decided based on demonstrated experience.

Benefits

Health Coverage: Medical, pharmacy, dental, and vision care.
Wellbeing Support: Programs such as BMS Well-Being Account, BMS Living Life Better, and Employee Assistance Programs (EAP).
Financial Well-being and Protection: 401(k) plan, short- and long-term disability, life insurance, accident insurance, supplemental health insurance, business travel protection, personal liability protection, identity theft benefit, legal support, and survivor support.
Work-life Benefits:
- Paid Time Off for US Exempt Employees: Flexible time off (unlimited, with manager approval), 11 paid national holidays (not applicable to employees in Phoenix, AZ, Puerto Rico, or Rayzebio employees).
- Phoenix, AZ, Puerto Rico, and Rayzebio Exempt, Non-Exempt, Hourly Employees: 160 hours annual paid vacation for new hires with manager approval, 11 national holidays, and 3 optional holidays.
- Based on eligibility, additional time off may include unlimited paid sick time, up to 2 paid volunteer days per year, summer hours flexibility, leaves of absence for medical, personal, parental, caregiver, bereavement, and military needs, and an annual Global Shutdown between Christmas and New Year's Day.

All global employees full and part-time who are actively employed at and paid directly by BMS at the end of the calendar year are eligible to take advantage of the Global Shutdown.

Schedule

BMS has an occupancy structure that determines where an employee is required to conduct their work. This structure includes Site-essential, Site-by-design, Field-based, and Remote-by-design jobs. The occupancy type is determined by the nature and responsibilities of the role:

Site-essential roles: Require 100% of shifts onsite at your assigned facility.
Site-by-design roles: May be eligible for a hybrid work model with at least 50% onsite at your assigned facility. Onsite presence is considered an essential job function and is critical to collaboration, innovation, productivity, and a positive company culture.
Field-based and Remote-by-design roles: The ability to physically travel to visit customers, patients, or business partners and to attend meetings on behalf of BMS as directed is an essential job function.