Senior Team Member - Clinical Trails

PFB the job description:

Job Purpose:

Support the planning, execution, and monitoring of clinical trials in India and APAC regions across therapeutic areas (respiratory, dermatology, oncology, gynaecology), contributing to data generation and regulatory submissions by ensuring quality, compliance, and timely delivery of trial activities.

Key Accountabilities:

Accountability Cluster

• Support Clinical Trial Execution
• Documentation & Review
• Data & Vendor Coordination
• Regulatory & Ethics Submissions
• Budget & Payments
• Scientific Support
• Stakeholder Management
• Continuous Learning

Major Activities / Tasks

• Ensure compliance with study protocols, GCP, and regulatory requirements
• Assist in planning and execution of clinical trials as per defined strategy and timelines
• Coordinate site identification, initiation, monitoring, and closure
• Assist in drafting and reviewing trial documents (Protocol, ICF, CRF, PIS, Subject Diary)
• Support translation/back-translation of documents
• Maintain Trial Master File and ensure completeness
• Coordinate with Data Management and Statistical teams for query resolution
• Liaise with vendors (CROs, labs, translation agencies) for outsourced activities
• Track and support logistics of clinical trial materials
• Prepare and submit documents to Ethics Committees and DCGI
• Ensure timely registration and updates on Clinical Trial Registry of India
• Support budgeting activities and track trial-related expenses
• Coordinate payments to investigators and vendors
• Contribute to abstracts, posters, and manuscripts for trial publications
• Provide operational inputs for Clinical Study Reports
• Collaborate with internal teams (Medical, Regulatory, Finance, Legal)
• Interface with investigators and site staff for trial conduct
• Participate in internal and external training programs
• Stay updated on clinical trial regulations and best practices

Major Challenges

• Managing multiple trial activities across sites with tight timelines
• Ensuring quality and compliance in a dynamic regulatory environment
• Coordinating with diverse internal and external stakeholders

Key Interactions

Internal

External

• Medical Services
• Regulatory Affairs
• Finance & Legal
• Data Management
• Portfolio & R&D Teams
• Investigators & Site Staff
• CROs & Vendors
• Ethics Committees
• Translation & Printing Agencies
• Insurance Providers

Dimensions

• Number of trials supported: 46 annually
• Budget handled: Support role in trials ranging from 0.5 Cr to 3 Cr
• Sites managed: 510 across India/APAC
• Documents handled: Protocols, CRFs, ICFs, CSRs, etc.

Key Decisions

• Decisions
• Recommendations
• Site visit scheduling
• Inputs on trial strategy and documents
• Vendor coordination
• Suggestions for vendor selection
• Document review inputs
• Recommendations for protocol amendments

Skills & Knowledge

Educational qualifications:

B.Pharm / M.Sc / M.Pharm / MBBS (preferred with diploma/degree in clinical trials)

Relevant experience:

• 4-6 years in clinical trial operations, preferably in pharma or CRO settings
• Experience in site coordination, documentation, and regulatory submissions
• Familiarity with GCP, ICH guidelines, and Indian regulatory landscape