Senior Study Leader

12-15 years

Not Disclosed

Hyderabad

10 Jan. 15, 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 Study Leader

Job ID: REQ-10020551
Location: Hyderabad, India
Posted on: January 7, 2025
Employment Type: Full-time, Regular

Role Summary:

The Senior Study Leader is accountable for the execution and delivery of clinical studies within Global Clinical Operations (GCO), adhering to the Operational Execution Plan (OEP) and clinical study protocols. This role leads the cross-functional Clinical Trial Team (CTT) to effectively plan and manage clinical studies, ensuring alignment with global objectives and timelines.

Key Responsibilities:

Leadership and Team Management:
- Lead CTT in the delivery of multiple complex global studies, promoting operational excellence and learning.
- Act as CTT product owner, ensuring team alignment and performance through agile principles.
Clinical Study Development:
- Collaborate with regulatory writing and clinical development teams to create high-quality clinical study protocols and related documents.
- Promote efficient and executable clinical protocols, translating approved concepts into actionable plans.
Study Timelines and Budget Management:
- Oversee clinical study timelines, ensuring milestones are met.
- Manage and monitor assigned study budgets.
Recruitment and Mitigation Strategy:
- Ensure successful study recruitment and implement mitigation strategies, in collaboration with Study & Site Operations (SSO).
Study Close-out and Documentation:
- Supervise all study close-out activities including site closure, drug accountability, and Trial Master File documentation.
Operational Excellence:
- Contribute to the preparation of Clinical Study Reports, reporting trial results, and internal/external publications.

What You'll Bring to the Role:

Education:
- Advanced or Bachelor's degree in life sciences/healthcare or a clinically relevant field (or equivalent).
Experience:
- 12-15 years of experience in Clinical Research or Drug Development across all phases.
- Significant experience working in a global/matrix environment in the pharmaceutical industry or Contract Research Organization (CRO).
- Expert knowledge of international standards (ICH-GCP) and health authorities (FDA/EMA).
Leadership and Teamwork:
- Experience leading and managing virtual and global teams, building effective working relationships with both internal and external stakeholders.
- Proven ability to resolve conflicts, negotiate effectively, and drive aligned solutions.
Project Management Skills:
- Strong project management skills with the ability to meet timelines and manage trial operations process improvements.

Why Novartis?

At Novartis, we strive to make a difference in the lives of patients by fostering a collaborative, inclusive work environment. By joining us, you’ll be part of a team that combines innovation and passion to change patients' lives.

Benefits and Rewards:
Discover how Novartis supports both your personal and professional growth through our Benefits & Rewards handbook.

Diversity and Inclusion:
Novartis is dedicated to an inclusive work environment, where diverse teams thrive.

Accessibility:
If you need accommodation due to a medical condition or disability, contact diversityandincl.india@novartis.com for assistance.

Division: Development
Business Unit: Innovative Medicines
Functional Area: Research & Development
Location: Hyderabad, Telangana, India

Lead global studies and make an impact. Apply Now

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Senior Study Leader

Job Description

Senior Study Leader

Role Summary:

Key Responsibilities:

What You'll Bring to the Role:

Why Novartis?

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