Senior Clinical Research Associate
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Job Location:
Monthly Salary:
Posted on:
18 hours ago
Vacancies:
1 Vacancy
Job Summary
Job Description Summary
Monitors patient data & study-related information related to clinical study sites and clinical trial participation. Ensures the investigator adheres to research protocols regulatory requirements and good clinical practices and provides input into data validation plan. Provides timely and accurate monitoring of patient data and study-related information from source documents research records and site visits where applicable. May monitor study sites and audit facility selection.Job Description
About the Role
The Senior Clinical Research Associate (sCRA) plays a pivotal sitefacing role responsible for ensuring highquality compliant and timely execution of clinical trials. The role focuses on proactive site oversight strong site partnerships and effective risk management to safeguard patient safety data integrity and inspection readiness.
Role Summary
The sCRA independently manages complex clinical trial sites across Phase IIV studies conducting onsite and remote monitoring activities in line with ICH/GCP local regulations and Novartis SOPs. Acting as the primary point of contact for sites the role drives sustainable site performance supports recruitment delivery and contributes to audit preparedness and continuous improvement initiatives.
Key Responsibilities
Serve as the primary liaison between Novartis and assigned investigational sites
Conduct Site Initiation routine monitoring (onsite and remote) and CloseOut visits as per Monitoring Plan
Ensure compliance with protocol ICH/GCP regulatory requirements and Novartis SOPs
Proactively identify site risks issues and deviations; drive timely mitigation and resolution
Build strong site partnerships to optimize patient recruitment flow and site performance
Ensure accuracy completeness and timeliness of site documentation and sTMF
Support audit and inspection readiness and implement CAPAs within agreed timelines
Collaborate crossfunctionally with CPMs CRA Managers Medical MSLs and other stakeholders
Essential Requirements
Degree in a scientific or healthcare discipline (or equivalent relevant experience). Minimum 4 years of pharmaceutical or clinical research experience
Handson experience in site monitoring and clinical trial execution
Strong knowledge of ICH/GCP regulatory requirements and clinical trial processes
Ability to manage sites independently with strong decisionmaking capability
Proficient written and spoken English and local country language
Willingness and ability to travel extensively (including overnight travel)
Desirable Requirements
Experience managing complex studies and/or less experienced sites. Prior involvement in audit and inspection readiness activities
Strong therapeutic area knowledge. Demonstrated ability to act as a Subject Matter Expert (SME). Experience working in global crossfunctional clinical teams. Strong digital and systems adaptability in a fastchanging environment
Skills Desired
Clinical Monitoring Clinical Research Clinical Study Reports Clinical Trial Management Systems Clinical Trials Collaboration Data Integrity Decision Making Skills LifesciencesRequired Experience:
Senior IC
About Company
Novartis is a global healthcare company based in Switzerland that provides solutions to the evolving needs of patients worldwide.
