Clinical Operations Specialist

hace 3 semanas

Ciudad de México Novartis Argentina A tiempo completo

Job ID- 363000BR- Mar 06, 2023- Mexico**Job Description**:

- +3000 People in the Novartis CONEXTS team, a global network of internal specialists providing high quality commercial, scientific, legal, digital and consulting services and solutions across the entire Novartis organization, with a focus on key markets, product launches and strategic initiatives. We create enterprise value by developing strong partnerships with our colleagues and building competitive advantages through innovation, standardization and scale-up, and productivity improvements.
- Your key responsibilities:
- Study budget management: Responsible for evaluation, negotiation and tracking of investigators fees (country level budget/Grant Plan) estimates per country related study costs.
- Support Clinical Project Manager (CPM) ensuring accurate planning, tracking and reporting of study budget. Champion the implementation of operational changes and transitions as required.
- Support CPM in the coordination of third-party vendors (i.e. central lab, investigators’ meeting organization) and supervising partner, ensuring all information, documentation and material in place for study start, with meetings set-up, minutes, running reports from systems, draft study documentation. Support with the study start up, recruitment and close out activities as required. Support in drug forecasting projections, keeping overview of drug availability at site and global level, collaborating with monitoring partner, drug supply management and other NOCC CONEXTS functions.
- Responsible for effective and smooth workflow between study participants. Follow-up with vendors and supervising partners on day to day operations (recruitment reports, delivery of study kits).
- Study logistics: Responsible for the set-up and maintenance of studies in Clinical Trial Management Systems (CTMS).
- Responsible for ensuring all key documents are present and filed as appropriate in Trial Master File (TMF). Ensure availability of study material for monitoring partner/sites (i.e. IV bags, fridge, laptops, etc ) including tracking of rented material.
- As applicable directly interact with investigator sites and CRAs/CROs/vendors to ensure smooth study set up and smooth study conduct, reviewing site performance, 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.
- Support compilation of study regulatory documents for submissions to proficient authorities and ethics-committees in collaboration with other associated NOCC CONEXTS, Novartis line functions and CRO Partners as required.

**Diversity & Inclusion / EEO**:

- Novartis is 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 or equivalent combination of education, training and experience.
- Proficient English (oral and written).
- 4-6 years’ of operational experience of clinical study execution in a pharmaceutical company or contract research organization.
- Strong technical and organizational skills (Excel, MP), Details oriented.
- Detailed knowledge of Good Clinical practice. Willingness to act accountably in project/study management.
- Demonstrated ability to establish effective working relationship in a matrix and multicultural environment. Proven presentation and diplomacy skills. Strong customer oriented approach.
- Experience in finance: forecast, actuals, cost reconciliation, a plus.

Why consider Novartis?
799 million. That’s how many lives our products touched in 2019. And while we’re proud of that fact, in this world of digital and technological transformation, we must also ask ourselves this: how can we continue to improve and extend even more people’s lives?
We believe the answers are found when curious, courageous and collaborative people like you are brought together in an inspiring environment. Where you’re given opportunities to explore the power of digital and data.
Where you’re empowered to risk failure by taking smart risks, and where you’re surrounded by people who share your determination to tackle the world’s toughest medical challenges.
Imagine what you could do at Novartis
Novartis embraces diversity, equal opportunity and inclusion. We are committed to building diverse teams, representative of the patients and communities we serve, and we strive to create an inclusion workplace that cultivates bold innovation through collaboration, and empowers our people to unleash their full potential.

Division
- CTS

Business Unit
- CONEXTS

Location
- Mexico

Site
- Distrito Federal

Compa

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