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Sr. Clinical Operations Specialist

5-6 years
Not Disclosed
10 Feb. 6, 2025
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

Senior Clinical Operations Specialist (Sr. COS) - REQ-10037384

📍 Location: Hyderabad, India
🗓️ Full-time

About the Role:

The Senior Clinical Operations Specialist (Sr. COS) will provide operational support for various clinical services and projects, including clinical studies (both interventional and non-interventional, from early to late phase), managed access programs (MAP), investigator-initiated trials (IITs), and other related services. The role involves supporting global study execution and collaborating with cross-functional teams to ensure successful project delivery.

Key Responsibilities:

  • Support clinical study execution and meet deliverables in alignment 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 Trial Master File (TMF) with all key documents properly filed.
  • Track study progress in CTMS, TMF, and other systems, and address issues or escalate 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.

Essential Qualifications:

  • Education: Bachelor’s degree in life sciences or equivalent combination of education and experience.
  • Experience: 5-6 years of global clinical study execution in the pharmaceutical industry or contract research organization.
  • Skills:
    • Experience in clinical operations and Good Clinical Practice (GCP).
    • Strong technical skills (Excel, PowerPoint).
    • Ability to work independently and manage priorities.
    • Strong communication and organizational skills.
    • Experience with project/study management.

Desirable Qualifications:

  • Experience in finance management (forecast, cost reconciliation).
  • Ability to establish effective working relationships in a matrix environment.
  • Strong customer-oriented mindset.

Why Novartis:

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.

Benefits & Rewards:

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

Commitment to Diversity & Inclusion:

Novartis is committed to building a diverse and inclusive work environment and encourages applicants from all backgrounds.

Apply Now