Sr. Clinical Data Manager

Bristol-Myers Squibb; Województwo mazowieckie; Hybrid; PLN 219,000 - 311,000; Full time

Job summary

A global pharmaceutical leader is hiring a Senior Clinical Data Manager to oversee data review tasks in clinical studies. The successful candidate will require a Bachelor’s degree and 4 years in Clinical Data Review, alongside proficiency in EDC systems and a strong understanding of clinical drug development. The role offers a blend of office work and remote flexibility: up to 50% remote opportunities available.

Benefits

Competitive benefits

Flexible work environment

Opportunities for professional growth

Qualifications

• 4 years of experience in Clinical Data Review tasks.
• Ability to work collaboratively on multi-disciplinary project teams.
• Strong knowledge of FDA/ICH guidelines.

Responsibilities

• Understand and review Protocol along with relevant study-specific data documents.
• Manage and facilitate resolution of data discrepancies.
• Provide training and mentoring to junior CDM staff.

Skills

Clinical Data Review

Collaboration

Strong Communication

EDC systems knowledge

Clinical Drug Development Process knowledge

Education

Bachelor’s Degree in Life Sciences or Pharmacy

Tools

Medidata RAVE

Microsoft Office

Job description

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 Senior Clinical Data Manager is a Clinical Data Management team member role considered essential to complete data review tasks on assigned studies across therapeutic areas. This role will report into a line manager within CDM. It is a fulltime 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:

Data Review

• Understand and review Protocol along with relevant study specific data review documents.
• Provide input to data review documents like Protocol Data Review Plan, Data Quality Management Plan.
• Review clinical data listings and prioritize critical data review.
• Manage and facilitate resolution of data discrepancies.
• Perform data cleaning as per the defined Clean Patient Group.
• Freezing & Locking of CRFs/Fields.
• Coordinate with Data Management Lead for studyables.

External Data

• Track data load and address discrepancies.
• Complete review of loaded external data and prioritize complex external data review e.g. Blinded Independent Committee Review, Biomarker, SAE.
• Coordinate with external data vendor for resolution of data discrepancies as applicable.

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.
• 4 years of experience in Clinical Data Review tasks.
• Able to work on clinical data review 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.

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.

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/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 [e-mail]. 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.