Associate Manager, Clinical Data Management

4 weeks ago

Hyderabad, Telangana, India Bristol Myers Squibb Full time
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 rich in diversity. 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: .

Functional Area Description

CDM is responsible for integrity, reliability, completeness and quality of clinical trial data and provides end to end clinical data management leadership for trials across the BMS R&D portfolio.

Position Summary / Objective

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 full- time office-based position with flexibility to work remotely up to 50% of the time over 2 weeks.

Position Summary / Objective

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.
Degree Requirements

Bachelor's Degree required. Life sciences, Pharmacy or relevant fields preferred.

Experience Requirements

4 years of experience in Clinical Data Review tasks

Key Competency Requirements
  • 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)

Describe Exposure to Any Hazards/Disagreeable Conditions in the Work

Environment

NA

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 scienceTM , 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 an inclusive culture, promoting diversity 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 a diverse 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.

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 . Visit eeo -accessibility to access our complete Equal Employment Opportunity statement.

BMS cares about your well-being and the well-being of our staff, customers, patients, and communities. As a result, the Company strongly recommends that all employees be fully vaccinated for Covid-19 and keep up to date with Covid-19 boosters.

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

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

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