Position: Clinical Trial Manager
Location: Bangalore, India
Experience: Minimum 2 years in Clinical Trial Management, 5+ years in onsite clinical monitoring
Industry: Pharma, Healthcare, Clinical Research
Application Deadline: 30th December 2024
Job Responsibilities:
- Study Oversight:
- Manage study commitments, ensuring quality and timelines.
- Lead local study teams, monitor performance, and ensure compliance with ICH-GCP and local regulations.
- Develop and oversee the Local Monitoring Plan.
- Team & Stakeholder Coordination:
- Supervise and coach study monitors and administrators.
- Organize investigator meetings and regular local team meetings.
- Collaborate with National Coordinators and Regulatory Affairs teams.
- Study Planning & Execution:
- Forecast timelines, resources, and recruitment.
- Coordinate investigator selection and site readiness.
- Ensure timely submission of documents to EC/IRB and regulatory authorities.
- Document Management:
- Maintain study master files and ensure proper archiving.
- Facilitate document translation and drug consumption planning.
- Compliance & Training:
- Ensure adherence to company policies and international guidelines.
- Provide training to team members and prepare for audits or regulatory inspections.
- Financial Oversight:
- Manage study budgets and facilitate accurate payments.
Candidate Requirements:
- Education: Bachelor’s degree in a relevant field.
- Experience:
- Minimum 2 years in Clinical Trial Management at a global CRO/Pharma.
- At least 5 years of onsite clinical monitoring experience.
- Skills:
- Strong understanding of ICH/GCP, clinical study processes, and drug development.
- Proficient in IT systems and tools for clinical trials.
- Excellent verbal and written English communication skills.
- Other:
- Must be based in Bangalore.
- Willing to work in an office-based setup.
Application Information:
- End Date: Applications close on 30th December 2024.
- Work Environment: Office-based in Bangalore.