As part of its expansion and continuous growth, Sun Pharma is hiring for two key positions: Sr. Clinical Research Associate (Sr. CRA) and Local Trial Manager (LTM) at its Gurgaon R&D center. These roles are crucial for ensuring the successful execution of clinical trials, regulatory compliance, and adherence to global quality standards.
Job Openings at Sun Pharma
1. Sr. Clinical Research Associate (Sr. CRA)
Job Responsibilities:
- Conduct end-to-end study-related onsite/remote monitoring.
- Ensure clinical trials are conducted in compliance with protocols, ICH GCP, and regulatory standards.
- Act as the primary communication point between Sun Pharma and clinical trial sites.
- Facilitate regulatory submissions and oversee the management of essential documents.
- Train and mentor Clinical Research Associates (CRAs).
- Support Regulatory Trial Leads (RTLs) on trial management tasks.
- Conduct site feasibilities, selection visits, and IRB submissions.
- Negotiate study budgets with trial sites and ensure Clinical Trial Agreements (CTAs) are executed in a timely manner.
- Manage site payments, monitor data integrity, and ensure patient safety.
- Oversee compliance with site visits, PD & SAE reporting, and audit readiness.
- Ensure effective communication and collaboration with cross-functional teams.
Qualifications & Experience:
- Minimum Bachelor’s or Master’s degree in Pharmacy or related science/healthcare fields.
- At least 5 years of experience in clinical research with 3-4 years of onsite monitoring experience in Phase II/III global clinical trials.
Key Skills:
- Strong knowledge of ICH GCP, clinical trial management, and regulatory requirements.
- Excellent communication and negotiation skills.
- Ability to manage site selection, feasibility, and study recruitment strategies.
- Strong organizational and time-management skills.
- Proficiency in site monitoring and audit readiness.
2. Local Trial Manager (LTM)
Job Responsibilities:
- Oversee site management activities and ensure compliance with study protocols.
- Act as the main communication link between Sun Pharma and trial sites.
- Train and mentor CRAs while ensuring efficient regulatory submissions.
- Plan and conduct Site Selection Visits (SSVs) and Site Initiation Visits (SIVs).
- Manage Clinical Trial Agreements (CTAs), site budgets, and payments.
- Ensure adequate IMP supplies and study protocol-required materials at sites.
- Develop and implement site recruitment and retention strategies.
- Support RTLs in trial management deliverables, including regulatory submissions and risk assessments.
- Monitor compliance with SAE reporting and data cleaning deliverables.
- Maintain study oversight trackers and ensure site readiness for audits.
Qualifications & Experience:
- Minimum Bachelor’s or Master’s degree in Pharmacy or related science/healthcare fields.
- At least 7 years of experience in clinical research with 3-4 years of onsite monitoring experience in Phase II/III global clinical trials.
- Prior experience in Project/Trial management is an added advantage.
Key Skills:
- Expertise in clinical trial site management and regulatory compliance.
- Strong leadership and team management capabilities.
- Excellent problem-solving skills and attention to detail.
- Ability to work collaboratively with cross-functional teams.
- Experience in risk assessment and mitigation strategies.
Application Link for Clinical Research Associate
