Not Specified
Full Time
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Skills
Key Account Management Relationship Management Result Orientation Negotiation Presentation Skills- Experience
- 2 to 5 Years
- Industry
- Pharma / Biotech / Life Science
- Functional Area
- Medical Professional / Healthcare Practitioner / Technician
Job Description
Ensure project coordination and conduct BA – BE / Phase I studies (Clinical) as per protocol and SOPs
Pre-study:
Review and finalization of protocol, ICF, CRF and other appendices
Communicate with sponsor on all projects related issues.
Ensure proper initiation and conduct of the trial.
During study:
Communicate with sponsors, other departments and team on appropriate aspects of the clinical studies
Ensure proper documentation of Adverse Drug Reactions, Note to files, Deviations etc.
Reporting of SAEs as per regulatory requirements
Ensure arrangement for activities like, ambulatory, precheck-in visits, post study and co-ordination of the same.
Co-ordinate QA audits of corrected forms.
Post study:
Generate protocol deviations
Send clinical updates to all concerned.
Send communications of discontinued subjects, BA details to concern.
- Company
- Lambda Therapeutic Research India
- Location
- Lambda Therapeutic Research India
Near Gujarat High Court, S. G. Highway, Gota, Ahmedabad 380061. Gujarat. India - Website
- http://www.lambda-cro.com
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