Basic Section
No. Of Openings
1
BAND
Z
Grade
Z3
Designation
Executive
Employee Category
HO
Organisational
Entity
Zuventus Healthcare Ltd.
Vertical
ZHL HO Mumbai
Department
Medical Services
Continent
Asia
Country
India
Zone
West
Location Type
ZHL- HO Mumbai
State
Maharashtra
City
Mumbai
Skills
Skill
- Clinical Research
Education Specialization
- Post Graduation
Minimum Qualification
- B.Sc
- Bachelor of Pharmacy (B.Pharm)
- Diploma in Pharmacy
Job Description
- Financial:Negotiating clinical trial budget with the CROs/Investigators.Operational:Preparation and amendment of SOPs for clinical trial activities.Clinical trial sites' qualification and selection.Tracking payments made to the CRO/Investigators/Ethics CommitteesProtocol DesigningCase Report Form (CRF) DesigningPreparation of dossier/documents for Regulatory submissionAddressing DCG(I) queriesCo-ordination with the CRO for timely completion of the clinical trial activitiesProtocol training of the study staffMonitoring and auditing clinical trial sitesCoordinate with investigators for conduction of clinical trialsArchiving study documentation and correspondenceSource Data Verification: Verifying that data entered in the CRFs is consistent with source dataAnalyzing the clinical study dataPreparing DCG(I) presentationsPreparing Clinical study reportsPreparing PSURsPreparing manuscripts for publicationReviewing the BA/BE protocols as per the regulatory requirements..