Manage clinical trials from initiation to closeout, ensuring compliance with regulatory requirements and ICH GCP guidelines.
Conduct site feasibility assessments and negotiate study budgets with sites.
Ensure timely execution of clinical trial agreements and oversee site invoicing.
Provide periodic updates on study progress, risks, and deliverables to stakeholders.
Lead communication with cross-functional units to ensure efficient study conduct.
Manage IMP supplies at sites and coordinate resupply orders.
Ensure recruitment and retention strategies at sites are on track and mitigate study recruitment risks.
Ensure compliance with PD & SAE reporting, audits, and inspections, performing site closeout visits and filing essential documents.
Foster healthy relationships and effective communication with site teams, and for outsourced trials, ensure quality by conducting accompanied visits with CRO monitors and following through on actions and CAPAs.

Job Requirements

Minimum 5 years of experience in clinical research, including at least 3-4 years of onsite monitoring experience for Phase II/III global clinical trials.
Strong knowledge of clinical research principles, regulations, and standards.
Excellent communication, negotiation, and problem-solving skills.
Ability to work independently and as part of a team.
Strong attention to detail and organizational skills.
Proficiency in medical terminology, labeling, and data review.
A Pharmacy Graduate (B.Pharm) or Post Graduate in pharmacy or related healthcare fields is required; additional qualifications are preferred.

Additional Info

The company offers opportunities for professional growth and development.

Disclaimer: This job description has been sourced from a public domain and may have been modified by Naukri.com to improve clarity for our users. We encourage job seekers to verify all details directly with the employer via their official channels before applying.

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