Senior Clinical Site Manager
Bristol Myers Squibb
Buenos Aires, AR
hace 6 días
source : DirectEmployers Association

Bristol-Myers Squibb is a global Biopharma company committed to a single mission : to discover, develop, and deliver innovative medicines focused on helping millions of patients around the world in disease areas such as oncology, cardiovascular, immunoscience and fibrosis.

Join us and make a difference. We hire the best people and provide them with a work environment that places a premium on diversity, integrity, collaboration and personal development.

Through a culture of inclusion, we create a better, more productive work environment. We believe that the diverse experiences and perspectives of all our employees help to drive innovation and transformative business results.

Summary Manages activities at the site and monitors study progress by close collaboration with other key stakeholders (e.

g. Medical Monitor, Protocol Manager, Clinical Trial Associates, Contract Administrators, and Site Monitor(s)) as applicable.

Disseminates information to appropriate BMS team members to ensure timelines are met. Proactively identifies and resolves issues noted during site management and informs the appropriate BMS team members .

Applies project management skills to plan for the study milestones and drivers. Keeps all stakeholders informed, escalate issues with proposals and drive solutions in coordination with other departments Ensures that site management activities, protocol execution and study documentation are in compliance with, ICH-GCP guidelines, BMS SOPs and local regulatory guidelines or regulations.

Shares experiences and best practices through coaching and feedback. Manages country selection and Target Setting Process at Country level for the assigned study.

Coordinates site selection activities by providing guidance as required and by collaboration with other key stakeholders (e.

g. Commercial Area, Clinical Trial Assistant, Contract Administrator and Site Monitor(s)). Reviews documents (protocol and ICF) ensures compliance with country to regulatory requirements.

  • Validates translation and leads regulatory query response . Performs periodic review of the electronic study file to ensure site level documents are in compliance with local regulations and SOP and are on file.
  • In collaboration with the Contract Administrator assesses whether the budget per patient is suitable to carry out the study, if necessary makes prrotocol budget negotiations with the central team.

    Participates in contract negotiations with sites, as required. Background B.S. degree in Science. Strong scientific background, good computer skills, ability to interact and communicate, both written and oral.

    Thorough understanding of ICH-GCP guidelines and local regulatory guidelines or regulations as they apply to protocol / site management.

    Knowledge of general clinical research including Investigator site issues, important milestones and strategies to ensure timelines are met.

    A detailed understanding of project planning and management methods. 2-5 years experience in clinical trial management Bristol-Myers Squibb recognizes the importance of balance and flexibility in our work environment.

    We offer a wide variety of competitive benefits, services and programs that provide our employees the resources to pursue their goals, both at work and in their personal lives.

    Data Privacy Link We're creating innovative medicines for patients fighting serious diseases. We're also nurturing our own diverse team with inspiring work and challenging career options.

    No matter the role, each one of us makes a contribution. And that makes all the difference. Bristol-Myers Squibb is an equal opportunity employer.

    Qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.

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