Dear Candidate,

Greetings!!

We are hiring Senior Site Manager - Clinical Operations

Job Title: Senior Clinical Research Associate (Senior Site Manager Clinical Operations)

Location: Thane, Mumbai

Experience: 2+ Years

:

We are looking for a Senior Clinical Research Associate (Sr. CRA) with at least 2 years of experience in clinical research and site management. The ideal candidate will be responsible for overseeing clinical trial activities, ensuring regulatory compliance, and managing study sites in accordance with ICH-GCP guidelines and applicable regulations.

Key Responsibilities:

- Manage regulatory and ethics committee submissions within defined timelines.
- Ensure all regulatory documents are complete, current, and maintained as per compliance requirements.
- Conduct site qualification visits in coordination with the Project Manager and/or Medical Monitor.
- Participate in or conduct Investigator Meetings and Site Initiation Visits (SIVs).
- Identify site training needs and coordinate/conduct study-specific training.




- Oversee study-related activities at assigned sites in coordination with the Project Manager.
- Perform routine site monitoring visits to ensure protocol compliance and data quality.
- Prepare, maintain, and update Trial Master Files (TMF), Investigator Site Files (ISF), and other study documentation in accordance with SOPs, ICH-GCP, and applicable Indian regulatory requirements.

Required Skills & Qualifications:

- Bachelor's degree in Life Sciences, Pharmacy, Nursing, or a related field.
- Minimum 2 years of experience as a Clinical Research Associate or in Clinical Operations.
- Positive understanding of ICH-GCP, Indian regulatory requirements, and ethics committee processes.
- Experience in site monitoring, site initiation, and regulatory documentation.
- Strong communication, coordination, and documentation skills.
- Willingness to travel for site visits, if required.

Interested candidate can share profiles on [email protected]

📌 Senior Clinical Research Associate/ Senior Site Manager (Mumbai)
🏢 Siro Clinpharm
📍 Mumbai