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Cadila Pharmaceuticals
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Manager - Bio Equivalence

Manager - Bio Equivalence

Name: Jobpe
Address: T-Hub, Plot No 1/C, Sy No 83/1, Raidurgam panmaktha, Knowledge City Rd, Hyderabad, Telangana, 500081, IN
Telephone: +91-83339-09630
Price range: Free

Cadila Pharmaceuticals

2 - 7 years

10 - 18 Lacs

Dholka

Posted:2 days ago| Platform:

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Skills Required

CRO Principal / Clinical Investigator for all BA/BE studies Investigation Overall monitoring & handling of all BA/BE studies supervising and reporting of BA/BE studies in accordance with Protocol conducting

Work Mode

Work from Office

Job Type

Full Time

Job Description

Major purpose of the Job:

Overall monitoring & handling of all BA/BE studies
Principal / Clinical Investigator for all BA/BE studies

Work as Clinical / Principal Investigator for the BA/BE and PK studies
Responsible for planning, conduct, monitor and reporting of BA/BE and PK studies in accordance to specifications laid down in protocol / applicable SOPs and regulatory requirements
Responsible for monitoring and ensuring safety of the volunteers participating in BA/BE and PK Studies
Responsible for adherence to ICH-GCP and conduct of the studies as per ICMR guidelines for Ethical Conduct of Biomedical Research Involving Human Subjects
Responsible for preparation, review and revision of SOPs / required formats and their implementation
Responsible for preparation and review of protocol, Case Report Form (CRF), final study report for BA/BE studies and documentation related to clinical study
Responsible to conduct pre-study meeting, protocol training and duty delegation for the study
Responsible for ICF presentation and medical query resolution.
Responsible for communication with IEC, Sponsor and different departments of CRO for timely completion of BA/BE studies
Responsible for conducting all clinical study related procedures including screening of volunteers, check in, dosing supervisor, check out and follow-up of the subjects.
Review of SAE form and all other documents related with SAEs for the assessment of causality, seriousness and expectedness during the conduct of clinical trials

Coordinate in sharing of SAE forms and detailed analysed report to the regulatory as per applicable regulatory guidelines.

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Manager - Bio Equivalence