Clinical Trial Associate

3 days ago

Chennai, India Levim Biotech Full time

**Job description**
- Manage Clinical & Non-Clinical study portfolios - design & develop protocols along with other clinical trial documents & reports that fit with the regulatory pathway and standards
- Responsible for planning, scheduling and implementing the clinical aspects of projects in-line with Monitoring Plan, Recruitment Plan, Clinical Training Plan with respect to contract and budget e.g. implementation of protocol and amendments, driving enrolment as per timeline, protocol deviation prevention, Clinical Data Tracking, Adverse Events, dropouts, CRF completion, annotated trip report, IMP management and responding to day-to-day clarifications or queries including CTRI & Sugam updates
- Responsible for Collection, review & maintenance of data/documents. Document clinical risks and develop mitigation strategies and associated action plans, including issue escalation and resolutions
- Ensure timely dissemination of information on study progress or issues and/or processes to all team members related to clinical deliverables and accurate tracking of any relevant study information related to clinical deliverables
- Responsible for developing successful cross-functional relationships with internal and external stakeholders including vendors. Serve as a primary contact and resource for the investigative site in order to ensure the smooth execution of assigned clinical study from initiation to close out
- Participate in business development activities such as Market research, developing Competitive Intelligence and support strategic decision making
- Support in Grant proposals, documentations & presentations

**Education requirements**
- Bachelor's/Master's degree in science
- MBA will be preferred

**Work experience**
- 2-5 year of work experience as Clinical Trial Analyst/Clinical Research Coordinator
- Strong knowledge regulatory pathway
- Strong documentation & data management skills
- Strong communication skills both written & oral
- Hands-on project management tools

**Salary**: From ₹21,043.17 per month

**Benefits**:

- Health insurance

Schedule:

- Day shift

Supplemental pay types:

- Yearly bonus

Ability to commute/relocate:

- Chennai, Chennai - 600113, Tamil Nadu: Reliably commute or planning to relocate before starting work (required)

**Experience**:

- total work: 1 year (preferred)

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