Title:  Senior Associate Project Management

Job Description

We are a technology-led healthcare solutions provider. We are driven by our purpose to enable healthcare organizations to be future-ready. We offer accelerated, global growth opportunities for talent that’s bold, industrious, and nimble. With Indegene, you gain a unique career experience that celebrates entrepreneurship and is guided by passion, innovation, collaboration, and empathy. To explore exciting opportunities at the convergence of healthcare and technology, check out www.careers.indegene.com Looking to jump-start your career? We understand how important the first few years of your career are, which create the foundation of your entire professional journey. At Indegene, we promise you a differentiated career experience. You will not only work at the exciting intersection of healthcare and technology but also will be mentored by some of the most brilliant minds in the industry. We are offering a global fast-track career where you can grow along with Indegene’s high-speed growth. We are purpose-driven.  We enable healthcare organizations to be future ready and our customer obsession is our driving force. We ensure that our customers achieve what they truly want. We are bold in our actions, nimble in our decision-making, and industrious in the way we work.

Must Have

The Senior Clinical Research Associate (Senior CRA) is responsible for leading clinical trial monitoring activities, mentoring junior CRAs, and ensuring study sites comply with regulatory and protocol requirements. This role involves higher autonomy in risk assessment, site management, and stakeholder collaboration while maintaining a focus on data integrity and patient safety.
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Key Responsibilities:
1. Advanced Clinical Trial Monitoring & Compliance
•    Independently conduct site selection, initiation, monitoring, and close-out visits across multiple sites.
•    Ensure compliance with ICH-GCP, FDA, EMA, and other regulatory guidelines.
•    Monitor and assess site performance, protocol deviations, and adherence to informed consent processes.
•    Proactively identify and mitigate risks at the site level.
2. Site & Stakeholder Management
•    Serve as a primary liaison for investigative sites, sponsors, and regulatory agencies.
•    Provide on-site training and mentorship to investigators and study coordinators.
•    Troubleshoot complex site-related issues and implement corrective/preventive actions.
3. Data Integrity & Reporting
•    Ensure high-quality data collection, source documentation, and adherence to study protocols.
•    Perform advanced source data verification (SDV) and identify trends in data discrepancies.
•    Lead efforts to resolve adverse events (AEs), serious adverse events (SAEs), and protocol deviations.
•    Prepare and review monitoring visit reports for quality assurance.
4. Leadership & Mentorship
•    Mentor and provide technical guidance to junior CRAs.
•    Assist in training programs for new CRAs and investigative site staff.
•    Support project teams with clinical trial design, feasibility assessments, and risk management.
5. Regulatory & Audit Readiness
•    Ensure sites maintain compliance with Essential Documents, IRB approvals, and regulatory submissions.
•    Support regulatory inspections, audits, and quality assurance activities.
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Desired Profile:
Education & Experience:
•    Bachelor’s or Master’s degree in Life Sciences, Pharmacy, Nursing, or a related field.
•    3-6 years of experience in clinical research monitoring.
•    Strong expertise in clinical trial regulations, risk-based monitoring, and site management.
Required Skills:
•    Proven ability to manage multiple sites and complex protocols.
•    Strong leadership, problem-solving, and decision-making skills.
•    Expertise in EDC systems, clinical trial management systems (CTMS), and safety reporting.
•    Willingness to travel extensively for site visits.

Good to have

EQUAL OPPORTUNITY

Indegene is proud to be an Equal Employment Employer and is committed to the culture of Inclusion and Diversity. We do not discriminate on the basis of race, religion, sex, colour, age, national origin, pregnancy, sexual orientation, physical ability, or any other characteristics. All employment decisions, from hiring to separation, will be based on business requirements, the candidate’s merit and qualification. We are an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, colour, religion, sex, national origin, gender identity, sexual orientation, disability status, protected veteran status, or any other characteristics.