Novo Nordisk is a global healthcare company with 89 years of innovation and leadership in diabetes care. The company also has leading positions within Haemophilia care, growth hormone therapy and hormone replacement therapy.
Post : CDC - Trial Manager
Job Description
As a CDC Trial Manager is the main accountable person in making sure that deliverables are met as per project timelines, within budget and complying with Protocol, country regulatory requirements, Helsinki Declaration, GCP (Good Clinical Practice) and SOPs (Standard Operating Procedures). Key responsibilities include: -
• Driving assigned clinical trial from the feasibility to Clinical trial reporting.
• The activities include planning, site selection, Ethics committee and health authority submissions, starting-up trial sites, organize investigator meetings.
• Training Site staff, CRAs, CTAs, start-up teams about the protocol and other protocol related information, providing operational and therapeutic expertise to the CDC project team, achieve deliverables within agreed timelines and in accordance with scientific, quality, and regulatory requirements.
• To ensure effective communication of all trial/project related issues between HQ, CDC, the region, and other Internal/external stakeholders.
• Responsible for representing CDC countries in relevant study meetings and organize these meetings: Trial Squad Meetings Monitor meetings, Investigator meetings, Study Result meetings.
Candidate Profile
• You should have a bachelor degree in life science, pharmacy, or nursing qualification or equivalent.
• You should have least 5+ years of experience in clinical monitoring.
• Basic GCP qualification and high level of understanding of GCP requirements.
• You must have advanced level knowledge of Excel and PowerPoint presentation.
• Good working knowledge of electronic clinical trials systems – IMPACT, EDC, IWRS, electronic TMF (Trial Master File).
• Good Communication and should be able to collaborate with internal and external stakeholders.
Additional Information
Experience : 5+ years
Qualification : B.Pharm, B.Sc
Location : Mumbai, Maharashtra
Industry Type : Pharma/ Healthcare/ Clinical research
Functional Area : Clinical Medical Regulatory (CMR)
End Date : 03rd May, 2024
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