Research Scientist

Job Description

• Accountable for successfully delivering the assigned clinical trial(s) in compliance with Lupin SOP, ICH-GCP and applicable • Ensure compliance with regulatory requirements within the assigned budget.
• Maintain and provide information regarding monthly study status, risks and mitigation strategies (including enrollment curves and timelines), and report this information to senior management.
• Lead the site selection process by identifying potential investigators for clinical trial(s).
•  Accountable for the timely submission of applications/documents to the applicable regulatory authority and IRB/EC at startup and throughout the duration of clinical trial(s).
•  Review study documents, such as the study protocol and ICF, and provide feedback.
• Ensure that clinical trial(s) are registered with the appropriate regulatory authorities.
• Prepare study and site-related manuals, plans, logs, and operational documents.
• Review protocol deviations and the escalation process to ensure that appropriate follow-up actions are taken.
• Oversee monitoring of the clinical trial, including reviewing visit reports and conducting co-monitoring visits with CRA(s) and/or sponsor oversight visits.
• Ensure that all aspects of GCP compliance and audit readiness are maintained throughout the conduct of the trial.
• Prepare reports and presentations on study progress for senior management.
• Lead CRA(s), CTA(s), and the project for assigned clinical trial(s).
• Provide significant input into the development of the Case Report Form to influence the final version.
• Manage clinical trial materials and assist in forecasting.
• Track and report on study expenditures. study spend

Work Experience

1. Minimum 6 years of clinical project management experience. 
2. Ability to manage delegated aspects of assigned clinical trial
3. Ability to manage CRO and Clinical Study Vendor
4. Robust understanding of ICH GCP and knowledge of Regulatory Requirement
5. Proficiency in MS office including  Word, Excel, Power point and other applications
6. Strong clinical stud/project management skills
7. Outstanding communication skills, both verbal and written
8. Ability to work Independently and prioritize duting
9. Understanding of EDC, CTMS, eTMF etc

Education

Competencies