Position: Clinical Trial Manager

Organization: The INCLEN Trust International

Location: Okhla-New Delhi

About Us: INCLEN is a unique global network of health professionals affiliated with key academic health-care institutions. The global headquarters is based at New Delhi (INDIA), and INCLEN has established Demographic, Developmental and Environmental Surveillance sites located at Palwal (Haryana), Bareilly (Uttar Pradesh), and Mawphlang (Meghalaya). INCLEN is dedicated to improve the population health by conducting collaborative, inter-disciplinary research on high-priority health problems nationally and globally. For more details, visit us at: www.inclentrust.org.

INCLEN is looking for a Clinical Trial Manager for managing its new and ongoing clinical trials at its Demographic, Developmental and Environmental Surveillance site.

Job Description:

Pre Implementation

1. Management of Trials - managing new and ongoing clinical trials.
2. Preparing Sites for Clinical Trial – Developing SOPs, Logs and Plan for implementation.
3. Document Development - He or she is in charge of preparing case forms, finalizing monitoring plan and data management.
4. Recruitment Plan - He or she is responsible for the development of recruitment methods to increase patient randomization into the trial.
5. Conducting site feasibility, site selection, site training and site initiation visit.
6. Managing approval for trials from an ethics committee
7. Delivery of clinical trial materials
Implementation
8. Development of monitoring plan and conducting on site and remote monitoring visits
9. Coordinating with the sites and the other relevant stake holders to ensure smooth implementation of the project.
10. Providing interim training, handholding and support to the research teams and clinical trial investigators, clinical trial nurses, and other clinical trial associates.
11. He/ She must also communicate with the sites and other collaborators to make sure the whole clinical trial team is consistently aware of any relevant information and issues.
12. Conduct audit of the implementation site
Post Implementation
13. Ensure proper closure of the trial including archival of the documents in paper and electronic platforms
14. Data cleaning and closure of data related queries through communication / onsite visit.
15. Ensure GCP compliance of the activities as per NDCT rules / ICMR guidelines.

Essential Qualifications:

• Bachelor’s degree in life science or closely related field
• GCP Training (offline training) certificate
• Two to four year of experience as Clinical Trial Manager / Assistant Clinical Trial Manager.

Desirable Skills:

• Master’s Degree in Clinical Research
• Specialized programs in clinical research - include courses in legal regulations, medical terminology, ethical issues, and clinical research databases, medical writing and trial master files.

Essential Skills:

• Team player - Ability to work as a team as well as independently
• Communication Skills - he or she must have strong written and verbal communication abilities and highly effective interpersonal skills.
• Confident Personality - He or she must also have the confidence to direct training sessions or conduct audits
• Documentation - Excellent organization and ability to focus on detail so that paperwork must be filed systematically and submitted to the appropriate individual or organization.
• Leadership Qualities - A clinical trial manager must also possess effective leadership abilities.

Remuneration: Commensurate with qualification and work experience.

Application Procedure: Please submit your Cover Letter and resume to the HR Department at hr@inclentrust.org with the subject line "Clinical Trial Manager" by 20th May 2024.

Address: The INCLEN Trust International, F-1/5, Second Floor, Okhla Industrial Area, Phase-1, New Delhi-110020, India, Phone: +91-11-47730000; Email: hr@inclentrust.org, visit us on www.inclentrust.org.