Clinical Project Manager
NOV CORPORATIVO MEX
Distrito Federal, Mexico
hace 1 día

Job Description

1 of the five Service Centers worldwide is based in Mexico with +1395 employees & +50 countries' scope. As a Diverse & Inclusive company, we are positioned in the Number 10th of Top Companies Rankings of places to work.

Contributing +450 Million Dollars in the growth domestic product (GDP) & generating +7000 employees directly & indirectly, our passion is to help patients improve and extend their lives.

Have you imagined all the work done before a patient can take his treatment?

YOUR KEY RESPONSIBILITIES :

  • Lead all aspects of global clinical trials to deliver study outcomes within schedule, budget, quality / compliance and performance standards.
  • Contributes to all operational trial deliverables, according to timelines, budget, operational procedures, quality / compliance and performance standards.
  • Conduct study start-up activities such as being responsible for protocol development, CRF development, Informed Consent Form development.
  • May identify new sites for clinical trials; analyze capability and make recommendation for trial inclusion.
  • Ensuring accurate handling of all study close out activities including but not limited to site close out, final drug accountability and audit readiness of Trial Master File documentation.
  • Responsible for education, implementation and compliance to standards (SOPs) and best practices for clinical operations within assigned clinical trial(s) and within clinical program(s), including sharing lessons learned.
  • Responsible for clinical execution and management of assigned clinical studies (interventional and non-interventional, from early phase to late phase) and other clinical services (e.
  • g. managed access programs (MAP), Research Collaborations etc.) executed by NBS CONEXTS on behalf of Novartis Organizations.

    WHAT YOU’LL BRING TO THE ROLE :

  • Core member of the Clinical Trial Team, Contributes to operational excellence through process improvement and knowledge sharing
  • Minimum requirements

  • Bachelor’s Degree or above, English proficiency
  • At least 8-10 years’ of Clinical Operations experience with managerial experience in planning, executing, reporting and publishing Global clinical studies in a pharmaceutical company or contract research organization.
  • Clinical Research Phases Clinical Trial Set-up, Management & Conduct Relevant educational background in life sciences / Healthcare
  • Thorough knowledge of Good Clinical Practice, clinical study design, statistics, regulatory processes, and global clinical development process.
  • Working in multi-national context and across countries
  • Strong customer orientation; Experience in working with different cultures, team located worldwide and cross-functionally;
  • Demonstrated presentation and tact skills. Negotiation and conflict resolution skills.

  • Proven track record to work independently in a sophisticated matrix environment (including remote).
  • DESIRABLE REQUIREMENTS :

  • Oncology experience preferred
  • Excellent project management skills.
  • Ability to resolve issues with minimal direction and understand when to raise.
  • Operations Management and Execution Project Management Financial Management Collaborating across boundaries
  • 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.

    Novartis is an equal opportunities employer and welcomes applications from all suitably qualified persons.

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

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