Assoc Manager, CDM

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: careers.bms.com/working-with-us.

Position Summary

The Associate Manager, Clinical Data Management is a Clinical Data Management team member role considered essential to complete end to end to data management tasks on assigned studies across therapeutic areas. This role will report into a line manager within CDM. It is a full-time office-based position with flexibility to work remotely up to 50% of the time over 2 weeks.

Position Responsibilities

Responsibilities will include, but are not limited to:

Study Startup:
- Draft EDC build timeline in collaboration with Data Management Lead.
- Perform DB build tasks by creating specifications for Database and Edit
Checks.
- Create test scripts and complete test data entry/UAT for Coding, Site
Payment, Safety Gateway.
- Collaborate with Data Management Lead and facilitate startup meetings
which includes, not limited to, EDC build kick-off, Interactive eCRF Build
and IRMs (Interactive Review Meeting) for database and Edit checks.
- Create and finalize study documents like Data Quality Management Plan,
eCRF completion Instructions, Protocol Data Review Plan (PDRP) post
study team review.
- Ensure all startup documents are completed as per SOP and filled in eTMF
as per eTMF master plan.

Study Conduct:
- Plan/execute Post Production/Migration for the study (if any).
- Coordinate with Clinical Data Managers for the execution of data review
tasks.
- Coordidate with external data vendors for any escalations related to any
vendor data.
- Support Clean Patient Group delivery along with Clinical Data
Management staff.
- Update study documents as needed during the conduct of the study
- Support DML to coduct Data Quality Review meetings.
- Provide Data Health Metrics to Data Management Lead as requested.

Study Closeout:
- Support Data Management Lead in planning and execution of database
lock activities.
- Perform post lock activities, as needed.

Project Management
- Support DML in project management tasks to make sure that study is
delivered successfully as per the study timelines with quality.

Documentation:
- Filing of appropriate documents in eTMF as per eTMF master plan.

Training and Mentorship:
- Provide Training and mentoring to junior CDM staff.

Requirements

Bachelor’s Degree required. Life sciences, Pharmacy or relevant fields preferred.
6 years of experience in managing end to end Clinical Data Management tasks.
Able to work on end to end Clinical Data Management tasks.
Able to work collaboratively on multi-disciplinary project teams.
Strong 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.
Strong oral and written communication skills.
Strong project management skills.
Travel Required Yes, 5-10% Industry Conferences, Investigator Meetings, Regulatory Inspections (as needed).

If you come across a role that intrigues you but doesn’t perfectly line up with your resume, we encourage you to apply anyway. You could be one step away from work that will transform your life and career.

Warsaw - PL: zł194,000 - zł235,087

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 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. The final compensation will be determined based on demonstrated experience and in accordance with pay equity principles and applicable employment laws.

Uniquely Interesting Work, Life-changing Careers
With a single vision as inspiring as “Transforming patients’ lives through science™ ”, every BMS employee plays an integral role in work that goes far beyond ordinary. Each of us is empowered to apply our individual talents and unique perspectives in a supportive culture, promoting global participation in clinical trials, while our shared values of passion, innovation, urgency, accountability, inclusion and integrity bring out the highest potential of each of our colleagues.

On-site Protocol

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 that you are assigned is determined by the nature and responsibilities of your 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. For these roles, onsite presence is considered an essential job function and is critical to collaboration, innovation, productivity, and a positive Company culture. For 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.

Supporting People with Disabilities

BMS is dedicated to ensuring that people with disabilities can excel through a transparent recruitment process, reasonable workplace accommodations/adjustments and ongoing support in their roles. Applicants can request a reasonable workplace accommodation/adjustment prior to accepting a job offer. If you require reasonable accommodations/adjustments in completing this application, or in any part of the recruitment process, direct your inquiries to adastaffingsupport@bms.com. Visit careers.bms.com/eeo-accessibility to access our complete Equal Employment Opportunity statement.

Candidate Rights

BMS will consider for employment qualified applicants with arrest and conviction records, pursuant to applicable laws in your area.

If you live in or expect to work from Los Angeles County if hired for this position, please visit this page for important additional information: https://careers.bms.com/california-residents/

Data Protection

We will never request payments, financial information, or social security numbers during our application or recruitment process. Learn more about protecting yourself at https://careers.bms.com/fraud-protection.

Any data processed in connection with role applications will be treated in accordance with applicable data privacy policies and regulations.

If you believe that the job posting is missing information required by local law or incorrect in any way, please contact BMS at TAEnablement@bms.com. Please provide the Job Title and Requisition number so we can review. Communications related to your application should not be sent to this email and you will not receive a response. Inquiries related to the status of your application should be directed to Chat with Ripley.

R1597181 : Assoc Manager, CDM