Support clinical study execution and meet deliverables aligned with business colleagues.
Manage Clinical Trial Management Systems (CTMS) and other systems for ongoing study data, milestones, and authorizations.
Assist the Clinical Project Manager (CPM) with study budget management, tracking, and reporting.
Maintain the Trial Master File (TMF) with all key documents properly filed.
Track study progress in CTMS, TMF, and other systems, addressing issues or escalating them to project leads.
Support study start-up, recruitment, and close-out activities as needed.
Lead external service provider coordination and ensure study readiness.
Organize meetings, draft project documentation, and maintain effective communication within the team.

Job Requirements

Bachelor's degree in life sciences or equivalent combination of education and experience.
5-6 years of global clinical study execution in the pharmaceutical industry or contract research organization.
Strong technical skills in Excel and PowerPoint.
Ability to work independently and manage priorities effectively.
Strong communication and organizational skills.
Experience with project/study management.
Experience in clinical operations and Good Clinical Practice (GCP).
Skills in 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, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding.

About Company

Novartis strives to improve and extend people's lives through innovative science, driven by a diverse and collaborative team. Join the mission to transform medicine and improve patient outcomes worldwide.

For detailed information on benefits and rewards, check out Novartis Life Handbook.

Disclaimer: This job description has been sourced from a public domain and may have been modified by Naukri.com to improve clarity for our users. We encourage job seekers to verify all details directly with the employer via their official channels before applying.

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Sr. Clinical Operat