The Associate Clinical Operations Specialist (ACOS) supports Clinical/Brand Team on various operational aspects of assigned projects/activities: clinical studies (interventional and non-interventional, from early phase to late phase) and/or other clinical services (e.g. managed access programs (MAP), Research Collaborations (RC), Investigator Initiated Trials (IITs), Digital Solutions etc.) or specific standalone services executed by Global Business Solutions on behalf of Novartis.

Associate Clinical Operations Specialist

Location – Hyderabad

About the Role:

The Associate Clinical Operations Specialist (ACOS) supports Clinical/Brand Team on various operational aspects of assigned projects/activities: clinical studies (interventional and non-interventional, from early phase to late phase) and/or other clinical services (e.g. managed access programs (MAP), Research Collaborations (RC), Investigator Initiated Trials (IITs), Digital Solutions etc.) or specific standalone services executed by Global Business Solutions on behalf of Novartis.

Key Responsibilities:

• Execute clinical services and meet planned deliverables in line with defined roles and responsibilities agreed with colleagues/business colleagues.
• Support set-up and maintenance of information in Clinical Trial Management Systems (CTMS) and other systems as applicable, under responsibility of Clinical Operational Specialists (COS) or Clinical Project Managers (CPM) as applicable: Update data, timelines, milestones, Ethics committee /Health Authority authorizations, etc. on an ongoing basis.
• Support (Sr.) Clinical Project Manager (CPM) with study budget management, ensuring accurate planning, tracking and reporting of clinical study budget.  Perform Good receipt booking in line with Vendor financial report and study status, as required.
• Support set-up and maintenance of Trial Master File (TMF): Ensuring that all key documents are present and filed as appropriate in TMF, under responsibility of COS or CPM as applicable. Follow up with Clinical Trial Team at agreed frequency for TMF maintenance.
• Support CPM in collecting key study information from External Service Provider involved in clinical service execution
• Track clinical service progress, ensure Clinical Trial Management System (CTMS), TMF and other systems as applicable are up to date, report to business colleague as per scope of work. Address questions; escalate issues or critical findings to project lead (Sr./CPM).
• Support in meeting set up and meeting minutes.
• Execute clinical services and meet planned deliverables in line with defined roles and responsibilities agreed with business colleagues.

Commitment to Diversity & Inclusion: :

We are committed to building an outstanding, inclusive work environment and diverse teams representative of the patients and communities we serve.

Essential Requirements:

• Bachelor’s Degree or above in life sciences) or equivalent combination of education, training and experience
• Approximately 2  years of operational experience of global clinical study execution in a pharmaceutical company or contract research organization.
• Experience in finance: forecast, actuals, cost reconciliation, a plus.
• Strong technical and organizational skills (Excel, PowerPoint)
• Thorough knowledge of Good Clinical practice.
• Demonstrated ability to establish effective working relationship in a matrix and multicultural environment.
• Able to manage priorities with minimum guidance. Willingness to act accountably in project/study management.

Desirable Requirements:

• Demonstrated ability to establish effective working relationship in a matrix and multicultural environment.
• Demonstrated presentation and diplomacy skills.
• Strong customer-oriented mindset.

How to Apply

If you meet the qualifications and are eager to advance your career in clinical research, this is a fantastic opportunity to work with one of the world’s leading pharmaceutical companies. Apply now to become a part of Novartis and contribute to innovations that improve lives globally.

This role is ideal for professionals looking to enhance their experience in clinical operations while working in a dynamic and collaborative environment. Stay tuned for more job updates from Cliniresearchjobs.com – your go-to platform for career opportunities in the clinical research industry.