Opportunity for M.Pharm, B.Pharm, MSc as Clinical Trial Lead at Cliantha Research

Cliantha Research, a full-service Clinical Research Organization (CRO), is a leading provider of Clinical research services, based in Ahmedabad, India. Cliantha’s motto is Science with Integrity. Cliantha has fifteen years of impeccable regulatory history with USFDA, WHO, MHRA, Health Canada, AGES, AEMPS, MCC, MOH, ANSM, MOPH, ANVISA, CAP, and NABL.

Post : Clinical Trial Lead

Department : Clinical Trials
Basic qualification required : B.Pharm / M.Pharm / M.Sc.
Experience : 6 - 8 Years – Site monitoring
Location : Ahmedabad

Job Description
1. The overall efficient day-to-day management of the trial.
2. Recruitment, retention, training, appraisal and supervision of trial team members.
3. Establishment of procedures to ensure adherence to trial protocols and administrative requirements.
4. Ensuring the timely recruitment of trial participants with secure randomization processes and subsequent efficient and effective data management.
5. Monitoring trial progress to ensure compliance with and adherence to the project plan and to identify, evaluate and rectify problems.
6. Management of the trial budget(s) and maintenance of the accounts.
7. Act as the point of contact for all external and internal agencies.
8. Co-ordinate the preparation and publication of data, reports and information, ensuring that they meet legislative, contractual and ethical requirements.
9. Understand the requirements of the various controlling bodies, agencies and frameworks, guiding the project in conforming to those requirements and coordinating any necessary audit processes.
10. Liaison with the Trials Steering Committee and Data Monitoring and Ethics Committee with a particular view on compliance with Research Governance, Good Clinical Practice, Data Protection and Ethical Requirements.
11. Work with the Chief Investigator to ensure that the trial is meeting its targets, is producing meaningful output and to predict and plan any changes that warrant requests to changes in protocol, funding or time.
12. Planning and supporting the meetings and work of the various groups and bodies associated with the trial.
13. Creation and maintenance of all trial files, including the trial master file, and oversight of site files.