Title: Principal Investigator

Experience: 15+ years

Qualification: MBBS/MD Pharmacology

Department: Clinical Research

Work Location: Cherlapally, Hyderabad

Reports to: Vice President CR

Responsibilities:

- Responsible for the end-to-end conduct of BA/BE studies in accordance with Valuable Clinical Practices (GCP), Protocol & SOPs.
- Responsible for Clinical TAT, Quality, staff attrition rate and staff training.
- Regulatory and sponsor audit handling.
- System upgradation and E-CRF implementation
- Responsible for delivering full scope BA/BE, Biosimilar research studies.
- To co-ordinate the progress of study activities within various team components such as Principal Investigators, Medical Investigators, Screening coordinator's, CRA's, Pharmacists, Paramedical, Medical Writing, QC, & Finance.
- To ensure that the clinical staff are meeting with defined workload & maintaining quality through regular review.
- To assess & provide clinical feasibility of BE study
- To co-ordinate with PM & BD team to achieve completion of various tasks related to study in the agreed timelines.
- Responsible for the review of study Protocol, ICF, CRF.
- Responsible for the review of Clinical Study Report.
- To communicate & co-ordinate with Sponsors as and when required. To co-ordinate with Independent Ethics Committee as and when required. To review departmental SOPs for necessary revisions as and when required.



Focus will be on the overall improvement & strengthening of system & processes.
- Responsible for the appropriate planning & scheduling of BE studies.
- Responsible to ensure the availability of sufficient eligible volunteers for the conduct of the study.
- Responsible to plan screening activity of volunteers as per protocol requirement.
- To evaluate eligibility of volunteers as per Inclusion/Exclusion criteria.
- Monitoring the conduct of study for appropriate quality compliance & for timelines during various stages.
- Conducting periodic meetings with respective Managers and Team members to assess accountability of tasks, it's progression & appropriate completion.
- To improve overall clinical conduct of study with minimal or no observations from OA! Sponsor /Regulatory body.
- To provide appropriate compliance to the audits conducted by QC/QA/Sponsor/Regulatory body.
- Appropriate selection of external vendors which plays vital role in the conduct of the study.
- To provide training to the clinical staff /study personnel's as and when required to improve overall conduct of the study.
- Responsible for the management of clinical staff in accordance with organization's policies & applicable regulations.
- Responsibilities include planning, assigning & directing the tasks, appraising performance && guiding them for professional development

📌 Principal Investigator (Hyderabad)
🏢 Vimta Labs
📍 Hyderabad