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10-12 years
Not Disclosed
10 March 2, 2025
Job Description
Job Type: Full Time Education: M.Pharm/Ph.D/BDS/MBBS Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

Project Manager

Functional Designation: Project Manager
Department: Clinical Operations
Location: Ahmedabad
Qualifications: M.Pharm, Ph.D, BDS, MBBS
Experience: 10 to 12 Years
CTC: 15-20 LPA
Special Skills: Project Planning, Team Management

Responsibilities:

  • Take primary responsibility for sponsor relationship and sponsor communication, ensuring high sponsor satisfaction.
  • Project initiation and planning, including conducting feasibility studies.
  • Arrange the kick-off meeting, inviting a representative from each functional area involved, ensuring the scope of the study is well understood by all functions and that the appropriate resourcing will be delivered by the functions for assigned projects.
  • Ensure the project is progressing according to quality standards, SOPs, ICH-GCP, and/or other guidelines to fulfill local regulations, and is completed within budget, as per schedule, and according to contract specifications.
  • Allocate CRA Managers/CRAs for clinical research projects.
  • Develop appropriate study tools and tracking systems for study execution.
  • Assist new CRA Managers/CRAs in identifying and developing investigators for assigned studies.
  • Coordinate and plan for the proper conduct of projects in liaison with CRA Managers/CRAs and communicate project-related and manpower requirements to Head Clinical Operations.
  • Provide protocol-specific training to CRA Managers/CRAs, including therapeutic expertise, CRF conventions, study procedures, and SOPs.
  • Assist and guide CRA Managers/CRAs in conducting pre-study, initiation, interim, and closeout monitoring visits as required.
  • Ensure effective communication between stakeholders and all project team members.
  • Identify and screen new sites and PIs, and create a database of new potential PIs and sites.
  • Coach and support project team members with tasks assigned to them.

Qualifications:

  • M.Pharm
  • Ph.D
  • BDS, MBBS