Sr Clinical Trial Manager
Hace 2 días
Buenos Aires, Argentina
IQVIA
Jornada completa
Gratis con email o Google
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The Sr Clinical Project Manager provide management of a clinical trial (s) in a global level. Services/deliverables include operational oversight of assigned project(s) at the global level for end-to-end project management from start-up through to closeout activities.
Tasks & Responsibilities:
- Ensure clinical delivery of assigned projects in compliance with regulatory requirements (International Conference on Harmonization (ICH)-Good Clinical Practice (GCP), protocol), customer requirements (contract), and internal requirements (policies, Standard Operating Procedures (SOPs), project plans).
- Accountable for meeting projects’ recruitment targets and ensuring appropriate recruitment strategies are in place.
- Contribute to the development of the project risk mitigation plan and manage clinical risks throughout the project’s lifecycle.
- Ensure clinical quality delivery by identifying quality standards/requirements, planning how compliance will be measured, monitoring and overseeing management of clinical quality issues. Essentials Requirements:
- Bachelor's Degree Health care or other scientific discipline Req
- Requires 8 years clinical research/monitoring experience or equivalent combination of education, training and experience.
- Minumun 3 years of regional/global trial management experience in the pharmaceutical industry or CRO.
- Requires in-depth knowledge of Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines.
- Specific Hematology TA experience.
- Requires good knowledge of project finances.
- Ensure clinical delivery of assigned projects in compliance with regulatory requirements (International Conference on Harmonization (ICH)-Good Clinical Practice (GCP), protocol), customer requirements (contract), and internal requirements (policies, Standard Operating Procedures (SOPs), project plans).
- Accountable for meeting projects’ recruitment targets and ensuring appropriate recruitment strategies are in place.
- Contribute to the development of the project risk mitigation plan and manage clinical risks throughout the project’s lifecycle.
- Ensure clinical quality delivery by identifying quality standards/requirements, planning how compliance will be measured, monitoring and overseeing management of clinical quality issues. Essentials Requirements:
- Bachelor's Degree Health care or other scientific discipline Req
- Requires 8 years clinical research/monitoring experience or equivalent combination of education, training and experience.
- Minumun 3 years of regional/global trial management experience in the pharmaceutical industry or CRO.
- Requires in-depth knowledge of Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines.
- Specific Hematology TA experience.
- Requires good knowledge of project finances.