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Assoc Lab Project Set-up Manager, Q2 Solutions

hace 3 meses

Buenos Aires, Argentina IQVIA A tiempo completo

Manage the process of designing and launching clinical research studies; manage activities of the Sponsor/Clinical Research Organization (CRO); lead colleagues in the design and organization of project components during Start-Up; develop and maintain best practices within the organization; Accountability and ownership for the quality of all start-up work and sponsor deliverables.


Essential Functions

  • Develop the database design requirements which include configuration definition for full protocols, protocol amendments and sponsor study changes
- developing and maintaining client design standards as applicable in accordance with the Clinical Protocol

  • Manage study database configuration. Support internal/external stakeholders in the development of sponsor standards and as a Setup point of contact
  • Collaborate with colleagues during planning meetings regarding project timelines, and projectrelated issues focusing on capabilities within, but not limited to, Data Management, Logistics, Clinical Trial Materials, Laboratory Testing, and Specimen Management
  • Responsible for updates to the project, including the action/issues logs, status sheets and timelines during the startup phase, where applicable
  • Communicate and coordinate setup activities with clients and internal customers to ensure that all milestones are achieved
  • Proactively manage changes in study related project scope, identify potential risks, and devise contingency plans
  • As required, prepare and present studyspecific materials and services at Investigator, Kickoff meetings. Participate in external and internal audits as required
  • Provide day to day guidance to more junior staff assigned to project or within a specific program area
- may act as a mentor as well as assist in the training and development of more junior staff

  • Participate in improvement projects as defined by the relevant process improvement management team. Conduct project lesson learn sessions and create a recommendations report in order to identify successful and unsuccessful project elements, when applicable
  • Work performed is in accordance with ICH E6 Guideline for Good Clinical Practice.

Qualifications

  • Bachelor's Degree Science or related field Pref
  • Other Equivalent combination of education, training and experience may be accepted in lieu of degree. Req
  • Minimum 2 years of clinical or research industry experience, including 1 year project management / project set up experience Pref Or
  • Equivalent combination of education, training and experience Req
  • Possess strong interpersonal skills.
  • Demonstrated ability to meet deadlines.
  • Some experience in leading Phase I-IV clinical trials would be advantageous. Some technical and therapeutic expertise would be advantageous, in addition to significant experience with key customers.
  • Demonstrated computer proficiency with Microsoft Office. Working knowledge of Clinical Trials Management Systems would be an advantage.
  • Possess an understanding of medical and clinical research terminology.
  • Demonstrated ability to work in a fastpaced environment.
  • Knowledge of Project Management processes and terminology.
  • Excellent organizational and time management skills.
  • Excellent accuracy and attention to detail skills.
  • Ability to establish and maintain effective working relationships with coworkers, managers and clients.