Local Clinical Operations Coordinator
ONCOLOGY
Bogotá D.C, Colombia
hace 4 días

Job Description

1.Act as local subject matter expert on all operational aspects of local sponsored studies, MAP and non-interventional trials.

As such, contribute to ensure adherence to global SOP and insure local SOP are aligned as appropriate.

  • 2.Manage local sponsored clinical trials including EAP, Compassionate Use MAP and non-interventional studies. Support the writing of clinical protocols and related documents in collaboration with the Oncology Medical Directors / Franchise or Therapeutic Area Head / Medical Advisors : lead the operational part of clinical trial protocol development process;
  • May contribute to the medical / scientific input for the development of trial-related documents; liaise with the CRO to obtain approval from internal review boards when applicable.

    3.Ensure the successful of the implementation and execution of local and Regional trials ensuring adequate resources are available in the CRO.

    4.Accountable for planning and executing local and Regional trials through all phases of the trial feasibility till CSR and publication.

  • 5..For local and Regional trials, ensure all deliverables are met according to timelines, budget, quality standards, SOPs and Business Guidance;
  • report study progress and issues with their resolution; lead trial level interactions with all relevant functions including Drug Supply Management and CROs.

    6..In collaboration with the Medical Directors and the CROs, leads the clinical trial data, medical / scientific review, interim and final analysis and interpretation including the development of local clinical trial reports, publications and internal / external presentations.

    7..Accountable for the development, management and tracking of trial budget (TCF) Accountable for accuracy and timelines of trial information in all trial databases and tracking systems.

    8.Collaborate with TA assuring implementation of third-party Investigator Initiated Trials (ITT), provide operational feedback on study proposals, review submitted study concepts / protocols for core requirements via the Study Express System.

    Ensure compliance with Novartis SOPs, Business Guidance and regulatory requirements. May Manage physician request as needed, ensure compliance with SAE reporting, and manage drug supply in collaboration with the CRO.

    Awareness of local regulatory requirements. Ability to manage Expanded Access programs

    9.Ensure optimal prioritization of operational activities for Local and Regional trials in line with TA strategic plans.

    Minimum requirements

    1.Act as local subject matter expert on all operational aspects of local sponsored studies, MAP and non-interventional trials.

    As such, contribute to ensure adherence to global SOP and insure local SOP are aligned as appropriate. 2.Manage local sponsored clinical trials including EAP, Compassionate Use MAP and non-

  • interventional studies. Support the writing of clinical protocols and related documents in collaboration with the Oncology Medical Directors / Franchise or Therapeutic Area Head / Medical Advisors : lead the operational part of clinical trial protocol development process;
  • May contribute to the medical / scientific input for the development of trial-related documents; liaise with the CRO to obtain approval from internal review boards when applicable.

    3.Ensure the successful of the implementation and execution of local and Regional trials ensuring adequate resources are available in the CRO.

    4.Accountable for planning and executing local and Regional trials through all phases of the trial feasibility till CSR and publication.

  • 5..For local and Regional trials, ensure all deliverables are met according to timelines, budget, quality standards, SOPs and Business Guidance;
  • report study progress and issues with their resolution; lead trial level interactions with all relevant functions including Drug Supply Management and CROs.

    6..In collaboration with the Medical Directors and the CROs, leads the clinical trial data, medical / scientific review, interim and final analysis and interpretation including the development of local clinical trial reports, publications and internal / external presentations.

    7..Accountable for the development, management and tracking of trial budget (TCF) Accountable for accuracy and timelines of trial information in all trial databases and tracking systems.

    8.Collaborate with TA assuring implementation of third-party Investigator Initiated Trials (ITT), provide operational feedback on study proposals, review submitted study concepts / protocols for core requirements via the Study Express System.

    Ensure compliance with Novartis SOPs, Business Guidance and regulatory requirements. May Manage physician request as needed, ensure compliance with SAE reporting, and manage drug supply in collaboration with the CRO.

    Awareness of local regulatory requirements. Ability to manage Expanded Access programs 9.Ensure optimal prioritization of operational activities for Local and Regional trials in line with TA strategic plans.

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