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Sdm - Study Data Manager

5-14 years
Not Disclosed
10 Dec. 27, 2024
Job Description
Job Type: Full Time Education: B.Sc./ M.Sc./ M.Pharm/ B.Pharm/ Life Sciences Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

Job Title: Lead Data Management (LDM) - Clinical Data Management

Location: Mumbai, Pune, Bangalore, Indore, Ahmedabad

Experience Range: 2 to 10 Years in Clinical Data Management

Educational Qualification(s): B. Pharma, M. Pharma, Pharma-D, BDS

Job Function: Business Process Services

Role: Executive


Job Description:

TCS is hiring for the Lead Data Management (LDM) role in Clinical Data Management!

Responsibilities:

  • Independently manage and be accountable for study data management deliverables.
  • Coordinate with biostatisticians, clinical, medical, and local study teams as needed.
  • Represent the Data Management team in cross-functional study meetings.
  • Manage all phases of Clinical Data Management, including setup, conduct, and close-out of studies.
  • Minimum 1 year of experience in leading clinical trials.
  • Provide training and mentorship to team members.
  • Draft study timelines and ensure that stakeholders adhere to them, escalating when necessary.
  • Collaborate with line managers on study-specific activities.

Skills Required:

  • Experience in clinical data management, clinical research, and project management.
  • Good communication skills and ability to collaborate across teams.
  • Knowledge of Clinical Data Management processes and best practices.

Qualifications:

  • Required: B. Pharma, M. Pharma, Pharma-D, BDS