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Senior Clinical Data Manager (External Data)

Fortrea
Fortrea
8+ years
Not Disclosed
Bangalore, India
10 April 22, 2026
Job Description
Job Type: Full Time Education: B.Pharm. or Post-Graduation (Microbiology/Quality Assurance/Biochemistry/Biotechnology) 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

Job Title:

Senior Clinical Data Manager


Company:

Fortrea


Job Overview:

The Senior Clinical Data Manager (CDM) provides end-to-end leadership of data management (DM) activities across clinical studies—from study start-up to database lock. This role involves project oversight, client interaction, team leadership, and process optimization, ensuring delivery of high-quality data within timelines and budget. The CDM also acts as a Subject Matter Expert (SME) and supports mentoring and strategic initiatives within the Biometrics function.


Key Responsibilities:

Project Leadership & Delivery:

  • Lead and manage DM activities across clinical studies
  • Take accountability for timelines, quality, and budget adherence
  • Oversee study documentation, system setup, data entry, and validation processes
  • Manage complex studies (multi-site, varied populations, tight timelines)

Vendor Data Management:

  • Develop and manage Vendor Data Plan (VDP)
  • Ensure accurate and complete external vendor data transfers
  • Validate format, structure, and mapping of incoming data
  • Review vendor Statements of Work (SOW) where applicable

Team Leadership & Mentorship:

  • Lead and guide DM study teams
  • Provide mentoring, coaching, and technical training
  • Review team outputs to ensure high-quality deliverables
  • Support performance evaluations and staff development

Cross-Functional Collaboration:

  • Work closely with:
    • Project Managers / FSP Leads
    • EDC Design, SAS Programming, Statistics, PK teams
  • Lead internal data-focused meetings and coordinate deliverables
  • Align timelines and milestones across departments

Client & Stakeholder Management:

  • Act as SME in sponsor meetings
  • Build and maintain strong client relationships
  • Understand sponsor requirements and implement solutions
  • Address feedback through process improvements and training

Risk Management & Quality Control:

  • Identify risks and develop mitigation strategies
  • Ensure compliance with:
    • Protocols
    • SOPs
    • GCP guidelines
  • Perform reconciliation of clinical data with:
    • Safety data
    • Lab data
    • Third-party data

Documentation & Compliance:

  • Maintain accurate study and project documentation
  • Support creation and updates of SOPs and process documents
  • Ensure all deliverables meet Data Management Plan (DMP) and scope requirements
  • Prepare for and support audits and inspections

Business & Strategic Support:

  • Support Business Development (e.g., bid defense, proposals)
  • Track scope changes and manage approvals
  • Provide input on budgeting, timelines, and pricing strategies
  • Promote Biometrics services to sponsors

Process Improvement & Innovation:

  • Continuously improve DM processes and workflows
  • Stay updated on new technologies and industry trends
  • Contribute to strategic initiatives and training programs

Qualifications (Minimum Required):

  • Bachelor’s degree or equivalent experience
  • Degree preferred in:
    • Life Sciences
    • Health Sciences
    • Information Technology
  • Fluency in English (written and verbal)

Experience Required:

  • 8+ years of Data Management experience
  • Minimum:
    • 2+ years sponsor/client management experience
    • 2+ years mentoring/leadership experience
  • Experience in:
    • Scope of Work (SOW) and budget management
    • Clinical trial processes and biometrics

Skills & Competencies:

  • Strong leadership and team management skills
  • Excellent communication and stakeholder management
  • Strong knowledge of:
    • Clinical data management
    • Clinical trial processes
    • CRO industry regulations
  • Problem-solving and decision-making ability
  • Ability to manage deadlines and multiple priorities
  • Mentorship and coaching capabilities

Technical Knowledge:

  • Experience with Electronic Data Capture (EDC) systems (preferred 4+ years)
  • Knowledge of data reconciliation, validation, and reporting
  • Familiarity with biometrics systems and tools

Preferred Qualifications:

  • Advanced knowledge of Fortrea systems and SOPs
  • Strong exposure to cross-functional clinical teams

Work Environment:

  • Office-based or remote setup
  • Potential travel up to 10% (including occasional overnight stays)
  • Requires extensive computer usage