After a journey of growth spanning 27 years as Cadila Healthcare Ltd. and the Zydus Group, we have evolved and transformed ourselves in response to the changing times. Our legacy of over 70 years in healthcare and being dedicated to life in all its dimensions is reaffirmed in our new mission, vision and purpose. Unifying ourselves under the Zydus name, Cadila Healthcare Ltd., is renamed as Zydus Lifesciences Ltd.
Post : Clinical Project Manager
Role Purpose
Responsible for Management of Clinical Trial.
Job Description
• Identify, prepare and optimize project resources and schedule.
• Review of Protocol, ICF, Clinical study report or any other study specific document
• Participate in site feasibility, selection, site initiation, monitoring and close-out in accordance with applicable standard operating procedure (SOP)/study specific plan and Good Clinical practice (GCP).
• Prepare and/or review study documents e.g., project management plan, communication plan, monitoring plan, note to file, deviation and other study specific plan based on requirements.
• Planning and execution of investigator meeting (if required).
• Review and/or approval of site feasibility, selection, site initiation, monitoring and close out report.
• Assist/provide project specific guidance, training to study team site staff and investigator.
• Ensure tracking, follow up and resolution of site and/or project specific issues in a timely manner.
• Maintaining of study specific files in compliance of respective SOP/study specific plan e.g. Trial Master file (TMF), Sponsor Site Master File, electronic TMF etc.
• Oversee and provide guidance to clinical trial assistant for the project specific duties
• Providing project specific training to study team, vendors, site staff etc.
• Lead the Trial Team to ensure all trial deliverables are met according to timelines, budget, quality standards and operational procedures.
• Constantly review the progress of studies and set benchmarks/expectations during the study
• Provide periodic update on trial progress to the HOD and/or Management.
• Execution and/or participation of study specific meeting or project specific management meeting.
• Assist and ensure archival of projects as per archival SOP.
• Preparation and/or review, tracking of project budget and get HOD and/or Management approval after discussion
• Review and execution of project specific contracts/Agreement.
• Review of project specific invoice and co-ordination for site/vendor payment
• Identification, selection and management of vendors/clinical research organisations (CRO’s).
• Co-ordination and/or evaluation of vendor as per project specific requirements
• Manage study-related vendors and serve as the primary point of contact for contracted CROs, labs, logistic and any other study specific service provider.
• Ensure compliance to GCP, protocol, Study specific plan, SOPs and applicable regulatory requirements
• Assist in planning of QC and/or QA and/or Regulatory inspection activities.
• Preparation response and CAPA (if required) for any observations during QC/QA/Regulatory audit or inspection
• Co-ordination and communication with internal and external cross-functional team (e.g. bioanalytical, CDM, medical writing, IP team, QC, QA, regulatory affairs etc.) to ensure proper execution and conduct of the trial to meet the project deliverable as per timeline
• Providing project specific training to study team, vendors, site staff etc.
• Preparation and/or review of SOP.
• To perform other duties as assigned by team incharge/HOD/Management
Candidate Profile
• Master degree or equivalent/in a Biomedical or Lifesciences /M.Pharm/M.B.A/Ph.D
• Experience of handling of clinical trial from Various Therapeutics Area
• 8 to 10 years of experience in field of Clinical research. Minimum 3 years of experience as a clinical project Manager.
• Team Management
• Competency in ICH-GCP and a strong interest in clinical research.
• Previous experience with Phase 1, 2, 3 and 4 studies essential
• Monitoring experience
• Co-monitoring experience
• Understand technical, scientific and medical information
• Understand clinical study budgets.
• Effective Communication
Additional Information
Experience : 8 to 10 years
Qualification : M.Sc, M.Pharm, M.B.A, Ph.D
Location : Ahmedabad, Gujarat
Industry Type : Pharma/ Healthcare/ Clinical research
End Date : 20th June 2024
See All M.Pharm Alerts B.Pharm Alerts B.Sc Alerts Ahmedabad Alerts
See All Other Jobs in our Database
Subscribe to Pharmatutor Job Alerts by Email
.png)
