Novartis Corporate Center Mexico City is one of six strategically located corporate centers established by Novartis globally. It brings together expert capabilities and talent across functionalities, that drives the business forward. It is home to 1000+ associates who work to deliver on the Novartis purpose of re imagining medicine to improve and extend people’s lives.
Your responsibilities:
Your responsibilities:
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- Execute clinical services and meet planned deliverables in line with defined roles and responsibilities agreed with colleagues/customers. Manage 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. Follow up with Clinical Trial Team at agreed frequency for TMF maintenance.
- Track clinical service progress, ensure CTMS, TMF and other systems, 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 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 CT Team and available to stakeholders.
- 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. Foster the implementation of operational changes and transitions as required.
- 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, investigation sites, clinical trial team, healthcare professional and other associated internal line-functions.
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.
Minimum requirements
- Relevant educational background in life sciences/Healthcare (Ideally a Bachelor’s Degree or above.
- Proficient English (oral and written)
- Approximately 3-4 years’ of operational experience in 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.
- Proven track record to establish effective working relationship in a matrix and multicultural environ-ment. Proven presentation and diplomacy skills.
- 3 7.Strong customer oriented mindset.8.Willingness to act accountably in project/study management. 9.Travel internationally/domestically as required
Why Novartis?
236 million lives were touched by Novartis medicines in 2022, and while we’re proud of this, we know there is so much more we could do to help improve and extend people’s lives.
We believe new insights, perspectives and ground-breaking solutions can be found at the intersection of medical science and digital innovation. That a diverse, equitable and inclusive environment inspires new ways of working.
We believe our potential can thrive and grow in an unbossed culture underpinned by integrity, curiosity and flexibility. And we can reinvent what's possible, when we collaborate with courage to aggressively and ambitiously tackle the world’s toughest medical challenges. Because the greatest risk in life, is the risk of never trying!
Imagine what you could achieve here at Novartis!
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
Division
Operations
Business Unit
CONEXTS
Country
Mexico
Work Location
Ciudad de México
Company/Legal Entity
NOV CORPORATIVO MEX
Functional Area
Research & Development
Job Type
Full Time
Employment Type
Regular
Shift Work
No
Early Talent
Yes
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