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Novartis

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4.1

based on 1.5k Reviews

245 Novartis Jobs

Sr. Clinical Operations Specialist

Novartis Healthcare Pvt. Ltd.

4.1

based on 1.5k Reviews

5-6 years

Hyderabad / Secunderabad

1 vacancy

Sr. Clinical Operations Specialist

Novartis

posted 3hr ago

Job Role Insights

Flexible timing

Key skills for the job

Pharmacy Hospital Administration Operations Recruitment Life Sciences Scheduling

+ 3 more

Job Description

Summary

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

About the Role

Sr. Clinical Operations Specialist

Location - Hyderabad #LI Hybrid

About the Role :

The Administrative Assistant and Project Coordinator is responsible to provide administrative support to MKS Head and MKS Leadership team including managing schedules, arranging appointments, arranging travel, and scheduling meetings, MKS Townhalls and other key governance meetings/calls. The role also provides support to Global Medical Affairs activities and governance taking place in the Hyderabad office.

Key Responsibilities:

Execute clinical services and meet planned deliverables in line with defined roles and responsibilities agreed with business colleagues.
Support set-up and maintenance of information in Clinical Trial Management Systems (CTMS) and other systems as applicable, under responsibility of COS or CPM as applicable: Update data, timelines, milestones, Ethics Committee (EC)/Health Authority (HA) 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 and Grant Plan as applicable.
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.
Track clinical service progress, ensure 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, coordination and meeting minutes, running reports from systems, draft project documentation.
Support and lead (where applicable) CTT in study start-up activities, recruitment and close-out activities as required. Takes ownership for specific tasks as delegated by project lead.
Support (Sr.) CPM in set up and coordination of External Service Providers, ensuring all information, documentation and material in place for study start during study conduct and close-out. Follow-up with External Service Providers on day-to-day operations.

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 5 to 6 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.

Employment Type: Full Time, Permanent

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