Experience in monitoring, experience in Handling Phase 2 & 3 studies
Submission : US-FDA / EMEA / DCGI
Conduct site feasibility (Identification & selection)
Perform EC submission
Prepare / Review of SIV package (including SMF).
Coordination with various stake holders eg. IP depo, IVRS, central laboratory, logistics vendors etc for site related activities
Ensure that the sites have the required clinical supplies for proper conduct of the study.
Perform site visits i.e. site selection, initiation, monitoring & close out, prepare and submit follow up letter, visit reports as per SOP & monitoring plan
Perform SDV & CRF review as per the monitoring plan
Review key study quality metrics (e.g., eligibility, primary endpoint data, etc.) and determine appropriate action in conjunction with study team.
Follow up with sites for issue resolution and implementing CAPA.
Training of Investigators on Protocol and other applicable regulatory guidelines including local regulatory guidelines.
Follow up with data management team for timely resolution of data queries.
Co-ordinate with sites in case of SAEs and ensuring timely reporting to all stakeholders
Initiate & track investigator, site and vendor payments.
Review & timely update Trial Master File & study folder as per SOP / study requirements.
Maintain and update study trackers (eg. Annexure I) & systems (e.g. CTMS) for the assigned projects.
Regularly obtain updated trackers / logs from sites, as applicable.
Follow up with the sites / vendors for all the pending documents.
Keep the study project manager and other team members informed of updates from sites.
Co-ordinate study document archival at sites.
Author or review SOPs as and when designated.
Complete assigned training & maintain updated personal training file for records.
Trained on ICH-GCP, Sch-Y and Indian GCP
Preferably experienced in Oncology, Ophthalmology, Diabetology, Osteology i.e. osteoporosis, osteoarthritis, Hematology, infectious disease & cardiology studies.
Salary : Not Disclosed by Recruiter
Industry : Pharma / Biotech / Clinical Research
Functional Area : Medical, Healthcare, R&D, Pharmaceuticals, Biotechnology
Role Category : R&D
Employment Type : Permanent Job, Full Time
Key Skills
Desired Candidate Profile
Please refer to the Job description above
PG : M.Pharma - Pharmacy
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