Clinical Operations Specialist

3-4 years

Not Disclosed

India

10 Dec. 25, 2024

Job Description

Job Type: Full Time Education: B.Sc./M.Sc./B.Pharm/M.Pharm/Life science Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, 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 Description: Clinical Operations Specialist
Location: Hyderabad, India (Hybrid)
Company: Novartis
Division: Operations
Functional Area: Research & Development
Employment Type: Regular, Full-Time

Job Summary:

The Clinical Operations Specialist is responsible for executing clinical services and ensuring the timely delivery of planned deliverables. This role supports clinical trials by managing documentation, data systems, and facilitating coordination with the Clinical Trial Team (CTT) and external service providers.

Key Responsibilities:

Clinical Trial Management:
- Support the setup and maintenance of information in Clinical Trial Management Systems (CTMS), ensuring accurate and timely updates for data, timelines, and authorizations.
- Help manage study budgets, track financials, and reconcile costs in collaboration with the Clinical Project Manager (CPM).
- Maintain and update the Trial Master File (TMF) with key documents, ensuring they are properly filed and accessible.
External Service Providers:
- Coordinate the setup and daily operations with external service providers, ensuring they have all necessary materials and information for the study.
- Support the team with day-to-day operations, ensuring smooth coordination throughout the study lifecycle.
Team Support & Communication:
- Track clinical service progress and provide regular updates on CTMS, TMF, and other systems as necessary.
- Assist in organizing meetings, coordinating study start-up activities, recruitment, and close-out activities.
- Assist in the creation of project documentation, running reports, and drafting meeting minutes.
Operational Changes & Transitions:
- Champion operational changes and ensure they are successfully implemented during the study.

Commitment to Diversity & Inclusion:

Novartis is dedicated to fostering an inclusive work environment and ensuring that diverse teams represent the patients and communities they serve. They value diverse perspectives and strive to create an equitable and supportive workplace.

Essential Requirements:

Approximately 3-4 years of operational experience in clinical study execution within a pharmaceutical company or contract research organization (CRO).
Experience in financial forecasting, cost reconciliation, and budget tracking is a plus.
Strong technical and organizational skills, including proficiency in Excel and other project management tools.
Detail-oriented with a strong ability to handle multiple tasks and deadlines.

Desirable Requirements:

Thorough knowledge of Good Clinical Practice (GCP) and regulatory guidelines.
Proven ability to work effectively in a matrix and multicultural environment.
Excellent presentation, communication, and customer service skills.

Why Novartis:

Novartis aims to reimagine medicine to improve and extend people's lives. The company values its employees and sees them as essential in achieving its mission. Join Novartis and contribute to a future where breakthroughs in medicine change patients' lives.

Benefits & Rewards:

Novartis offers a comprehensive benefits and rewards package to support employees’ personal and professional growth. For more details, refer to the Novartis Life Handbook.

This role offers an opportunity to contribute to meaningful projects in clinical trial management while working within a collaborative and innovative environment.

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Clinical Operations Specialist

Job Description

Job Summary:

Key Responsibilities:

Commitment to Diversity & Inclusion:

Essential Requirements:

Desirable Requirements:

Why Novartis:

Benefits & Rewards:

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