Senior Clinical Research Associate

3+ years

Not Disclosed

Delhi

10 July 25, 2024

Job Description

Job Type: Full Time Education: B.Sc./ M.Sc./ M.Pharm/ B.Pharm/ Life Sciences Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

Summary

At any given time, over 100,000 patients are participating in Novartis' clinical trials. The Global Clinical Operations (GCO) team at Novartis is dedicated to enabling faster trial recruitment and delivery, ensuring patients gain timely access to potential novel treatments. This pivotal role bridges the gap between science and medicine, allowing for a significant impact on patient care.

About the Role

Job Purpose:

The Senior Clinical Research Associate (sCRA) plays a crucial role in site relationship management, ensuring the sustainable execution of clinical trials. The sCRA is responsible for on-site and remote monitoring activities for Phase I-IV GDD trials, adhering to ICH/GCP guidelines, local regulations, and SOPs. This role involves proactive site performance management, addressing site needs, and acting as the main contact for all site-related issues and risks.

Key Responsibilities:

Site Management and Monitoring: Manage assigned study sites, conducting trials according to the Monitoring Plan and Novartis procedures. Perform Site Initiation Visits, train site personnel, and conduct continuous monitoring activities to ensure compliance with all relevant standards and regulations.
Process Improvement and Compliance: Identify deficiencies in site processes, work with sites to implement improvements, and promote a culture of compliance. Ensure human subject protection and the reliability of trial results.
Collaboration and Communication: Establish strong partnerships with sites to optimize patient recruitment and site performance. Collaborate with internal stakeholders, including the SSO Clinical Project Manager, CRA Manager, MSL, CRMA, and medical advisor, to enhance study outcomes and data quality.
Documentation and Audit Readiness: Maintain accurate and up-to-date site documentation, including the Investigator Folder and sTMF(s). Participate in audit and inspection readiness activities, implementing corrective actions as needed.
Training and Mentorship: Provide continuous training for site personnel, including new site staff and re-training as necessary. Mentor associates and share best practices to ensure high standards of site management.
Data Quality and Risk Management: Oversee the data query resolution process, ensuring timely and accurate data entry. Monitor and report site performance, escalating risks and issues as appropriate.

Qualifications:

Education: Degree in a scientific or healthcare discipline (or equivalent experience in the United States).
Language Skills: Fluent in written and spoken English and the local language.
Experience: Minimum of 3 years in the pharmaceutical industry or a related field, with a strong understanding of the clinical trial process and drug development.
Competencies: Strong decision-making abilities, excellent time management and organizational skills, and a risk-based mindset. Proficient in clinical and therapeutic knowledge, and familiar with international standards (GCP/ICH, FDA, EMA).

Why Novartis?

Novartis is driven by a mission to reimagine medicine, improving and extending lives worldwide. Our vision is to become the most valued and trusted medicines company globally, a goal we pursue through the dedication and innovation of our associates. Join us in this mission and help shape a brighter future.

Commitment to Diversity & Inclusion:

Novartis is committed to building an inclusive and diverse workplace that reflects the communities we serve.

Benefits and Rewards:

For more information about the benefits and rewards offered at Novartis, please refer to the Novartis Life Handbook.

Join our Novartis Network:

If this role doesn't align with your experience or career goals, consider joining our Novartis Network to stay informed about future opportunities.

Location: Delhi, India

Division: Development

Business Unit: Innovative Medicines

Company / Legal Entity: Novartis Healthcare Private Limited

Functional Area: Research & Development

Job Type: Full-time, Regular

Shift Work: No

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Senior Clinical Research Associate

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