Post Market Surveillance Analyst
Intuitive
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Job Description
 Location: [Add Location] | Requisition ID: R363606
Job Type: Full-Time |Â Hybrid/Remote options may apply
Introduction
We are seeking a dedicated and detail-oriented Clinical Research Associate (CRA) to join our clinical operations team. As a CRA, you will play a critical role in ensuring the quality, accuracy, and compliance of clinical trials while serving as the main link between the sponsor and investigative sites. This role offers the opportunity to work across multiple therapeutic areas, contribute to innovative clinical research, and help bring life-changing therapies to patients worldwide.
What You Will Do
- Oversee assigned clinical trial sites to ensure compliance with study protocols, ICH-GCP guidelines, and applicable regulations.
- Build and maintain strong relationships with investigators, site staff, and key stakeholders.
- Perform monitoring activities both on-site and remotely, ensuring data integrity, patient safety, and regulatory adherence.
- Support study start-up, site activation, ongoing monitoring, and close-out activities.
- Act as a subject matter expert (SME) in monitoring processes, supporting colleagues, and contributing to continuous improvement.
Role & Responsibilities
- Serve as the primary site contact for clinical studies throughout all trial phases.
- Conduct site initiation, monitoring, and close-out visits to ensure protocol adherence, patient safety, and data accuracy.
- Verify completeness and accuracy of data in source documents, eCRFs, and regulatory submissions.
- Identify, assess, and escalate issues related to site performance, recruitment, or compliance.
- Collaborate with cross-functional teams (regulatory, pharmacovigilance, data management, legal, etc.) to resolve site-level challenges.
- Maintain up-to-date records in CTMS, eTMF, and other clinical systems.
- Participate in audits, inspections, and quality oversight activities as required.
- Contribute to site selection and feasibility assessments, supporting the growth of high-performing clinical research sitesShare best practices and mentor junior CRAs or new team members when needed.
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Educational Qualification
- Education:
- Bachelor’s degree (or higher) in Life Sciences, Nursing, Pharmacy, or related healthcare/scientific field.
- Associate’s degree with significant relevant experience may also be considered.
- Bachelor’s degree (or higher) in Life Sciences, Nursing, Pharmacy, or related healthcare/scientific field.
- Experience:
- Minimum 2 years of direct site management/monitoring experience in a CRO, pharmaceutical, or biotech environment.
- Solid understanding of ICH-GCP, regulatory requirements, and clinical trial processes.
- Minimum 2 years of direct site management/monitoring experience in a CRO, pharmaceutical, or biotech environment.
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Location
Gurgaon ,Haryana , India.
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