This is a temporary contractor opportunity at Novartis 

Novartis touches the lives of a tenth of the world’s population. Every role here, regardless of contract type, makes an impact on human life! 

Novartis partners with external managed service provider Magnit Global to offer engaging temporary contractor opportunities like this, to those who are looking for flexibility in their career while looking to gain new skills and experiences providing services to an inclusive global medicines company. Click here to learn more about Magnit www.magnitglobal.com 

Ready to work with/through Magnit at Novartis? Please read on... 

The Clinical Operations Specialist 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), Re-search Collaborations, IIT, Digital Solutions etc.) or specific standalone services executed by CONEXTS on behalf of Novartis Organization.

Major Activities:

• Execute clinical services and meet planned deliverables in line with defined roles and responsibilities agreed with colleagues/customers.
• 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, EC/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. 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.
• Track clinical service progress, ensure CTMS, TMF and other systems as applicable are up to date, report to colleague/customer as per scope of work. Address questions; escalate issues or critical findings to project lead (Sr./CPM).
• Support in External Service Provider coordination:
  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.
  Ensure all data is reported to the Clinical Trial Team and available to colleague/customer.
  Logistical support to study team (internal and external) onboarding process.
   
• Support in meeting set up, coordination and meeting minutes, running reports from systems, draft project documentation.
• Support CTT in study start-up activities, recruitment and close-out activities as required.
• Champion the implementation of operational changes and transitions as required.

Other Responsibilities:

As applicable, support CPM in directly interact with investigator sites and CRAs/CROs/vendors to ensure smooth study set up and conduct, reviewing site performance (e.g. queries, recruitment), protocol deviations, ongoing risk assessment and timely issue resolution in alignment with Novartis global standard and local regulatory requirement. Also, if needed support clinical studies with all onsite/remote monitoring activities and communications with investigators, investigational sites, clinical trial team, healthcare professional and other associated internal line-functions.

Ideal Background:

• Relevant educational background in Life Sciences/Healthcare (Ideally a Bachelor’s Degree or above in life sciences) or equivalent combination of education, training and experience.
• Approximately 3-4 years’ of operational experience of 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, MP,), Details oriented.
• Thorough knowledge of Good Clinical practice.
• Demonstrated ability to establish effective working relationship in a matrix and multicultural environment.
• Demonstrated presentation and diplomacy skills.
• Strong customer oriented mindset.
• Willingness to act accountably in project/study management.
• Travel internationally/domestically as required.
• Fluent English (oral and written).

Workload: 40 hours per week
Role type: Hybrid

Why Novartis:  Our purpose is to reimagine medicine to improve and extend people’s lives and our vision is to become the most valued and trusted medicines company in the world. How can we achieve this? With our people. It is our associates that drive us each day to reach our ambitions. Be a part of this mission and join us! Learn more here: https://www.novartis.com/about/strategy/people-and-culture 

Commitment to Diversity and Inclusion / EEO: Novartis is committed to building an outstanding, inclusive work environment and diverse teams representative of the patients and communities we serve. 

Join our Novartis Network: If this role is not suitable to your experience or career goals but you wish to stay connected to hear more about Novartis and our career opportunities, join the Novartis Network here: https://talentnetwork.novartis.com/network 

Accommodation: If you require reasonable accommodation in completing this application, interviewing, completing any pre-employment testing, or otherwise participating in the employee selection process, please direct your inquiries to Magnit at directsourceproteam@prounlimited.com