Senior Clinical Data Management Specialist

1 week ago

Hyderabad, Telangana, India beBeeClinical Full time ₹ 1,20,00,000 - ₹ 2,00,00,000

About the Role:

We are seeking an experienced Clinical Data Manager to join our team. As a Clinical Data Manager, you will be responsible for managing end-to-end clinical data management tasks, including study startup, conduct, and closeout.

Key Responsibilities:

  • Draft EDC build timelines in collaboration with Data Management Leads
  • 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 Leads 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
  • Plan/execute Post Production/Migration for the study (if any)
  • Coordinate with Clinical Data Managers for the execution of data review tasks
  • Coordinate 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 conduct Data Quality Review meetings
  • Provide Data Health Metrics to Data Management Lead as requested
  • Support Data Management Lead in planning and execution of database lock activities
  • Perform post lock activities, as needed
  • Support DML in project management tasks to make sure that study is delivered successfully as per the study timelines with quality
  • Filing of appropriate documents in eTMF as per eTMF master plan
  • 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

Work Environment:

BMS has an occupancy structure that determines where an employee is required to conduct their work. The occupancy type that you are assigned is determined by the nature and responsibilities of your role. For site-essential roles, onsite presence is 100% at the assigned facility. For site-by-design roles, onsite presence is at least 50% at the assigned facility. Field-based and remote-by-design roles require the ability to physically travel to visit customers, patients or business partners and to attend meetings on behalf of BMS as directed.

About Us:

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.

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