Project Manager

3 meses atrás

São Paulo SP, Brasil ODC Life Sciences Tempo inteiro

Position Mission:

Responsible for the detailed clinical research project plan and problem solving, from project start, follow up and completion as agreed with client.

Main attributions:

  • Managing the full project cycle: resources, schedule, quality standards, issues, risks and changes to ensure successful delivery, within budget and with the expected results;
  • Plan, implement and monitor the evolution of the project informing and directing appropriately to the other areas involved in each phase, stage or activity required throughout the execution of the clinical research project;
  • Ensure that all actions related to the clinical research project follow international, national and good clinical practice guidelines as required excellence in the execution, conduct and management of each project;
  • Create, maintain and share the planning and evolution spreadsheets of each stage of the clinical research project among all those involved in the development of the management activities of a project, including but not limited to: regulatory, import and export, laboratory, clinical operations, financial, legal among others necessary for the proper performance of the required activities;
  • Lead, motivate and mentor project team members to perform and achieve goals;
  • Plan the team's schedule according to the sponsor's objectives;
  • Monitor activities and organize information from CMSLs to the sponsor;
  • Develop and implement actions to engage key opinion leaders through visits, meetings, provision of information and communication to keep them motivated to work according to the protocols and/or research centers;
  • Identify new opportunities that represent regulatory solutions;
  • Recruitment of new research centers, meetings with KOL, 360º relationship, building timeline, approval of documents regarding ODC responsibilities in the execution of the study proposal;
  • Manage regulatory submissions with country experts, reviewing timelines for obtaining documentation and checklist for drug dossier and protocol submission;
  • Plan the feasibility of the clinical trial and coordinate its execution in order to achieve the KPIs;
  • Monitor CRO activities to ensure compliance with protocols and regulations.

Academic Background:

  • Healthcare, Business Administration, Engineering,
  • Desirable post-graduation in Health area, Projects, among others

Language:

  • Advanced English

Time of experience in the position:

  • Minimum of 3 years of experience in project management in Clinical Research

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