Instagram
youtube
Facebook

Clinical Trial Associate (Cta)

1+ years
Not Disclosed
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 Novartis, over 100,000 patients are engaged in our clinical trials at any given time. Our Global Clinical Operations (GCO) team is designed to expedite trial recruitment and delivery, providing patients with timely access to innovative treatments. As a key link between science and medicine, you could significantly impact patient care.

About the Role

Job Purpose:

The Clinical Trial Associate (CTA) supports the SSO Study Start-Up Manager and SSO Clinical Project Manager throughout the study lifecycle, ensuring compliance with Novartis processes, GCP/ICH, and regulatory requirements. This role involves coordinating document collection, system setup, vendor selection, and ensuring the accuracy and completeness of trial documentation.

Key Responsibilities:

  1. Document Management: Collect, prepare, and adapt documents for submission to IRB/EC and Health Authorities. Manage the Investigator File (IF) and Trial Master File (TMF), ensuring compliance with regulatory and Novartis standards.

  2. Site Support and Coordination: Provide logistic support for site setup and trial initiation, including vendor setup and management. Ensure all necessary documentation is in place for drug release and site "Green Light" readiness.

  3. Translation and Material Preparation: Assist in translating informed consent forms and preparing patient-facing materials, managing vendors as necessary.

  4. Strategic Collaboration: Work closely with the SSU Team Lead and SSU Managers to meet timelines and deliverables, ensuring adherence to financial standards and regulatory requirements.

  5. Process and System Management: Utilize systems like CREDI/SUBWAY for document management and archiving. Maintain strong knowledge of MS Excel, Word, PowerPoint, and SAP.

Role Requirements:

  • Education: Vocational qualification, bachelor's degree, or equivalent education in a commercial or medical field, preferably with clinical operations experience.
  • Language Skills: Fluent in English and the local language as required.
  • Experience: Ideally, several years of work experience with at least one year in clinical operations, with a strong understanding of clinical trial setup and contracting.
  • Competencies: Proficient in MS Office applications and SAP, with a solid understanding of international drug development standards (GCP/ICH), FDA/EMA, and local regulatory requirements.

Skills & Knowledge:

  • Strong process and system understanding
  • Self-motivated, structured, and committed approach to work
  • Excellent prioritization and coordination skills
  • Demonstrated collaboration and communication abilities

Why Novartis:

Our mission is to reimagine medicine to improve and extend lives, aiming to be the most valued and trusted medicines company globally. Achieving this vision is possible with our dedicated and passionate associates. Join us in creating a brighter future by exploring more about our mission and culture.

Commitment to Diversity & Inclusion:

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

Benefits and Rewards:

For detailed information about our benefits and rewards, refer to the Novartis Life Handbook.

Join our Novartis Network:

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

Location: Mumbai, 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