Are you passionate about clinical research and looking to contribute to groundbreaking advancements in medicine? Novartis, a global leader in the pharmaceutical industry, is seeking a dynamic Associate Clinical Operations Specialist (ACOS) to join their team in Hyderabad. This hybrid role offers the opportunity to collaborate with multidisciplinary teams and support critical projects that impact patients worldwide.
About the Role
The Associate Clinical Operations Specialist (ACOS) plays a pivotal role in supporting Clinical and Brand Teams across various operational aspects of assigned projects. These projects include clinical studies (both interventional and non-interventional, spanning early to late phases) and other clinical services such as:
- Managed Access Programs (MAP)
- Research Collaborations (RC)
- Investigator Initiated Trials (IITs)
- Digital Solutions
Additionally, the ACOS is involved in standalone services executed by Global Business Solutions on behalf of Novartis.
Key Responsibilities
Clinical Services Execution
- Deliver clinical services in alignment with predefined roles and responsibilities.
- Ensure projects meet planned deliverables and timelines.
System and Data Management
- Set up and maintain information in Clinical Trial Management Systems (CTMS) and other relevant platforms.
- Regularly update data, timelines, milestones, and authorizations.
Budget and Financial Support
- Assist Senior Clinical Project Managers (CPM) in study budget management.
- Plan, track, and report on clinical study budgets.
- Perform Good Receipt booking based on vendor financial reports and study statuses.
Trial Master File (TMF) Maintenance
- Support the setup and ongoing maintenance of the TMF, ensuring all key documents are appropriately filed.
- Collaborate with the Clinical Trial Team to ensure regular updates.
Collaboration and Communication
- Coordinate with External Service Providers for key study information.
- Track clinical service progress and update stakeholders as needed.
- Organize meetings and document minutes effectively.
Escalation and Issue Resolution
- Address questions and escalate critical issues to the project lead.
- Ensure compliance with Good Clinical Practice (GCP) standards.
Essential Requirements
- Educational Background: Bachelor’s degree or higher in Life Sciences or an equivalent combination of education and experience.
- Experience: At least 2 years of operational experience in global clinical study execution within a pharmaceutical company or Contract Research Organization (CRO).
- Technical Skills: Proficiency in Excel, PowerPoint, and other organizational tools.
- Knowledge Base: Thorough understanding of Good Clinical Practice (GCP).
- Interpersonal Skills: Ability to build effective relationships in a multicultural and matrix environment.
- Project Management: Capable of managing priorities with minimal guidance and acting accountably in project/study management.
Desirable Qualifications
- Demonstrated presentation and diplomacy skills.
- Strong customer-oriented mindset.
- Experience in finance, including forecasting, actuals, and cost reconciliation.
