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Clinical Project Manager

8+ 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

Clinical Project Manager

Location – Hyderabad (Hybrid) #LI-Hybrid

About the Role:

The Clinical Project Manager is responsible for leading and managing a multidisciplinary Clinical Trial Team (CTT), encompassing areas such as medical writing, statistics, data management, monitoring partners, drug supply, regulatory, and safety. This role involves effective planning, regular re-evaluation, and implementation of assigned clinical studies, MAP/Research Collaborations, IIT, or Digital Solutions programs according to Novartis Global processes. The focus is on ensuring adherence to timelines, budget, quality standards, and operational procedures.

Key Responsibilities:

  • Collaborate with colleagues and customer teams to establish realistic project and study timelines, escalating issues when necessary.
  • Lead or support a cross-functional CTT in planning, re-evaluating, and implementing clinical studies and programs.
  • Organize investigator meetings and internal meetings related to clinical study execution and operational excellence.
  • Interact with investigator sites, CRAs/CROs/vendors to ensure smooth study setup and conduct, monitor site performance, manage protocol deviations, and resolve issues.
  • Support the compilation of study regulatory documents for submission to authorities and ethics committees, collaborating with Novartis line functions and CRO Partners as needed.
  • Oversee all site visit-related reports and ensure timely quality control of monitoring activities.

Commitment to Diversity & Inclusion:

Novartis is dedicated to creating an inclusive work environment and building diverse teams that reflect the communities we serve.

Essential Requirements:

  • Approximately 8 years of Global Clinical Operations experience, with managerial experience in clinical study design, planning, execution, reporting, and publishing.
  • Proven ability to work independently in a complex matrix environment, including leading cross-functional teams.

Desirable Requirements:

  • Strong project management skills, knowledge of Good Clinical Practice, clinical study design, statistics, regulatory processes, and global clinical development.
  • Excellent presentation, negotiation, and conflict resolution skills, with a customer-oriented mindset.

Why Novartis:

Novartis aims to reimagine medicine to improve and extend lives, striving to be the most valued and trusted medicines company globally. Our mission is driven by our people, who collaborate to achieve breakthroughs that transform patients' lives. Join us in this mission and learn more about our culture and opportunities.

Benefits and Rewards:

Discover more about the benefits and rewards offered by Novartis in the Novartis Life Handbook: Novartis Life Handbook.

Join our Novartis Network:

If this role doesn't align with your experience or career goals, stay connected with us through the Novartis Network to learn about future opportunities: Novartis Network.

Division: Operations
Business Unit: CTS
Location: India
Site: Hyderabad (Office)
Company / Legal Entity: IN10 (FCRS = IN010) Novartis Healthcare Private Limited
Functional Area: Research & Development
Job Type: Full-time
Employment Type: Regular
Shift Work: No