Individual will be the representative of the organization in the assigned city & will be the single point of contact for the vendor partners.
Individual should have the experience of managing clinical trial & study independently.
Should have knowledge of developing study monitoring plans
Should have experience working in Pharmacokinetic & pharmacovigilance reports / projects
Monitor & ensure that the trial partners successfully complete the trial within the agreed times
Ensure zero error & risk mitigation during the trails
Ensure data is verified, consistent and recorded thoroughly so that there are no errors
Manage & audit study documents as per regulatory requirements
Maintain in-house ISFs and TMF, as assigned
Ensure implementation of Risk Based Monitoring with CPM.
Should be aware of Good Clinical Practices and applicable regulatory standards.
Individual will also be responsible for identifying feasible sit, get into contracts / manage vendor, ensure proper handover documentation & monitor the study overall until its closure.
Should be well versed in CTMS, Tracking tools, project tracking & planning
Job Location Ahmedabad, Gujrat (India)
Salary: Not Disclosed by Recruiter
Industry:Pharma / Biotech / Clinical Research
Functional Area:Medical, Healthcare, R&D, Pharmaceuticals, Biotechnology
Role:Clinical Research Manager
Employment Type:Permanent Job, Full Time
Desired Candidate Profile
UG:B.Pharma - Pharmacy
PG:M.Pharma - Pharmacy