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Centralized Study Spec I

Fortrea
Fortrea
5-8 years
Not Disclosed
Bangalore, India
10 April 22, 2026
Job Description
Job Type: Hybrid 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:

Clinical Operations / Study Support Specialist


Job Overview:

The Clinical Operations Specialist is responsible for supporting clinical study management, data review, system administration, and investigator payments. The role involves coordinating with cross-functional teams, ensuring compliance with clinical systems, and maintaining high-quality study documentation and reporting throughout the study lifecycle.


Key Responsibilities:

Clinical Systems & Study Management:

  • Manage clinical systems such as:
    • CTMS (Clinical Trial Management System)
    • IWRS
    • EDC
  • Maintain study databases and ensure data accuracy
  • Perform system setup for new studies
  • Manage access control for study systems
  • Ensure CTMS compliance

Document & eTMF Management:

  • Manage study documents and support eTMF (electronic Trial Master File)
  • Assist in document creation, collection, review, and tracking
  • Support investigator submission packages for regulatory/site submissions

Study Coordination & Communication:

  • Track and follow up with CRAs for outstanding issues
  • Manage internal and external communications
  • Organize and support study-related activities
  • Assist study teams with contracts, budgets, and startup activities

Data Review & Reporting:

  • Perform data review and follow up on action items
  • Generate and analyze study-specific reports
  • Collaborate with Data Management and Programming teams
  • Draft and distribute reports as per study requirements

Investigator Payments:

  • Review EDC and contract data for payment readiness
  • Process payments via CTMS
  • Perform invoice quality checks and prepare GIA (if applicable)
  • Coordinate approvals with project stakeholders
  • Handle expense invoices and payment reconciliation

Quality & Compliance:

  • Follow Standard Operating Procedures (SOPs) and Work Instructions
  • Perform quality checks on deliverables
  • Ensure compliance with ICH-GCP and regulatory guidelines
  • Maintain project documentation and metrics tracking

Process Improvement & Tools:

  • Identify opportunities for process improvements
  • Support implementation of new tools and systems
  • Track and report performance metrics

Training & Leadership:

  • Mentor and train new team members
  • Perform quality checks as part of QC process
  • Lead or support process improvement initiatives
  • Facilitate meetings and influence stakeholders

Qualifications (Minimum Required):

  • Bachelor’s degree (preferably in Life Sciences)
    OR certification in allied health fields (e.g., Nursing, Medical/Lab Technology)
  • Equivalent experience may be considered

Experience Required:

  • 5–8 years of experience in clinical research or related roles
  • Additional experience in professional roles (0–5 years acceptable)

Skills & Competencies:

  • Strong planning, prioritization, and organizational skills
  • High attention to detail and accuracy
  • Effective communication and interpersonal skills
  • Ability to work collaboratively in teams
  • Strong problem-solving and decision-making skills
  • Ability to influence and lead initiatives
  • Capability to facilitate meetings and manage stakeholders
  • Consistent delivery of high-quality work

Preferred Qualifications:

  • Flexibility to work in shifts as per business needs

Work Environment:

  • Office-based or remote work setup
  • Extensive use of computer and keyboard