Job Title:  Manager - Scientific Management, Medical Services

ORGANISATIONAL OVERVIEW

Lambda Therapeutic Research is a Global full-service Clinical Research Organization (CRO) with its headquarters in Ahmedabad, India. With facilities and operations strategically located in Mehsana (India), Las Vegas (USA), Toronto (Canada), Barcelona (Spain), London (UK) and Warsaw (Poland), we offer comprehensive end-to-end clinical research services to the global innovator, biotech, and generic pharmaceutical industries.

JOB DETAILS

Feasibility Grid Preparation:

• Preparing the feasibility for the Clinical trials as per the requirement of the sponsors.
• Reviewing Feasibility Questionnaires and feasibility reports.

Medical Writing:

• Prepare and review study related documents like Protocol Synopsis, Study Protocols, Investigator’s Brochure, Informed consent forms, Clinical study reports, Patient diaries etc.
• Liaises with the study team, Sponsor and the key opinion leaders in therapeutic areas to finalize the study related documents.

Medical Monitoring:

• Medical Monitoring at site level is comprised of review of Site Investigator File, Safety and SAE reporting documents, Laboratory documents and reports, X-ray and ECG reports.
• Medical monitoring performed remotely at Lambda Office comprises of providing guidance, if required by PI/study team, which will include, but not be limited to, eligibility criteria, study procedures and patient continuation and discontinuation. It also comprises of reviewing the adverse events and Serious Adverse Events (SAEs) documents, occurring in the trial and ensure proper recording and reporting of the same.

Training:

• Train the study team members of the study protocols and other study related documents.
• Train the members of the department on the various therapeutic / technical areas
• Site initiation visits.

General Duties:

• Keep abreast with the development in the field of clinical research in India and overseas.
• Comply with quality initiatives designed by the department.

EXPERIENCE

• 1-2 years in Medical Monitoring role.

EDUCATIONAL QUALIFICATION

• M.D. Pharmacology