Clinical Project Lead | Mumbai | Abbott

Job Description

Purpose of Role:

• Summarize the main purpose of the role.
• Leads/supervises a team of more than 2 professionals within the Medical Affairs Sub-Function.
• First level manager of a work team that may comprise professionals, technical and/or administrative staff.
• Typically without budget or hire/fire authority.
• Focuses on mentoring, coaching, and coordination.

Main Responsibilities:

• As the Supervisor of the Medical Affairs Sub-Function supervises professionals in overseeing the direction, planning, execution, clinical trials/research, and data collection activities.
• Contributes to the implementation of clinical protocols, and facilitates completion of final reports.
• Recruits clinical investigators and negotiates study design and costs.
• Responsible for directing human clinical trials, phases III & IV for company products under development.
• Participates in adverse event reporting and safety responsibilities monitoring.
• Coordinates and provides reporting information for reports submitted to the regulatory agencies.
• Monitors adherence to protocols and determines study completion.
• Coordinates and oversees investigator initiations and group studies.
• May participate in adverse event reporting and safety responsibilities monitoring.
• May act as consultant/liaison with other corporations when working under licensing agreements.

QUALIFICATIONS

Education
Associates Degree (± 13 years)        ☐
Experience/Background
Minimum 4 years