Company Description

At Novaspire, we pride ourselves on being a trusted partner to the pharmaceutical industry, dedicated to delivering comprehensive, high-quality clinical research services. We specialize in supporting pharmaceutical, biotechnology, medical device, and nutraceutical companies at every stage of the drug/product development lifecycle, from clinical studies Phase I to post-market surveillance. Novaspire's core services include pharmacovigilance, clinical trials, medical writing, bioequivalence study support, Gx P consulting services & training, and imaging studies. With over 75 years of combined experience, our team has guided companies through the complexities of Gx P compliance by providing solutions and streamlining processes.

Role Description

· Plan and conduct site feasibilities, site selection visits, site initiation visits, monitoring visits, close out visits across Pan India Novaspire clinical sites/hospitals.

· Prepare and send the confirmation and respective site visit reports as per the SOPs.





· Send the visit follow-up letters and coordinate on action items with respective clinical site teams.

· Coordinate for the site-set up activities.

· Ensure the site and trial master files are updated.

· Coordinate with clinical site teams for prompt data entries, source data verifications, data entry errors, corrections and closure of data issues.

· Oversee end-to-end processing of ICSRs (spontaneous, literature, clinical trial, and solicited reports).

· Contribute to narrative writing and seriousness assessment.

· Analyse and handle product complaints and medical inquiries with cross-functional collaboration.

· Conduct regular and ad hoc literature surveillance for safety signals and case identification.

· Ensure audit readiness and adherence to company SOPs and regulatory expectations.

· Coordinate with clinical sites, investigators, and internal teams to ensure timely execution of study activities.

· Prepare and review essential tria

📌 Senior Clinical Research Associate (Bengaluru)
🏢 Novaspire Biosciences
📍 Bengaluru