Associate Clinical Trial Leader

2+ years

Not Disclosed

Hyderabad

10 June 27, 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

Job Summary

Position: Clinical Trial Associate
Location: Hyderabad, India
Company / Legal Entity: IN10 (FCRS = IN010) Novartis Healthcare Private Limited
Division: Biomedical Research
Business Unit: Pharma Research
Functional Area: Research & Development
Job Type: Full-time
Employment Type: Regular
Shift Work: No

The Clinical Trial Associate supports all aspects of TCO clinical trial(s) under the guidance of the Lead Clinical Trial Leader (LCTL) and/or Clinical Trial Leader (CTL) and the Clinical Program Leader (CPL).

Major Accountabilities

Lead Studies: May lead studies in maintenance or closeout phase or ongoing studies post-primary database lock with oversight.
Protocol Development: Support the clinical protocol development process in collaboration with CTL/Lead CTL and CPL; contribute to the development of clinical protocols, amendments, and related documents.
Regulatory Documents: Assist in the development of the clinical section of regulatory documents like Investigator’s Brochure, safety updates, IND/NDA submission documents, and responses to Health Authorities.
Multidisciplinary Team Support: Support the global multidisciplinary Clinical Trial Team (CTT) to ensure trial deliverables are met according to timelines, budget, quality standards, and operational procedures.
Data Review and Analysis: Support the ongoing review and cleaning of clinical trial data, final analysis, and interpretation, including clinical trial reports, publications, and presentations.
Data Availability: Coordinate the real-time availability of quality clinical trial data for dose escalation meetings with investigators.
Database Accuracy: Ensure accuracy of trial information in all trial databases and tracking systems.
Meetings: Attend relevant meetings to support the execution of clinical trial and program-level activities.
Program Standards: Ensure that program-specific standards and activities are applied to the clinical trial.
Outsourcing Specifications: Develop clinical outsourcing specifications to facilitate bid templates and selection of CROs and other third parties; manage the interface with external vendors.
Best Practices: Support the implementation of best practices and standards for trial management.

Key Performance Indicators

Support CTLs in planning, executing, and closing early phase trials on time and within budget.
Adherence to GCP/ICH guidelines for high-quality trial conduct.
Ongoing data review to support trial decisions and strategic planning.

Minimum Requirements

Educational Qualification: Advanced degree or equivalent in life science/healthcare. Bachelor’s degree or equivalent if accompanied by at least 2 years of clinical study involvement.
Work Experience: Good communication, organization, and tracking skills. Basic knowledge of Good Clinical Practice and scientific principles.

Skills

Clinical Trials
Conflict Management
Contract Management
Effective Communication
Financial Analysis
Negotiation Skills

Why Novartis

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Associate Clinical Trial Leader

Job Description

Job Summary

Major Accountabilities

Key Performance Indicators

Minimum Requirements

Skills

Why Novartis

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