Clinical Project Manager Previous Regional/Global - Only Latam Candidates - Home Based

Syneos Health, Inc.; Quilmes; Vor Ort; ARS 181.747.000 - 272.620.000; Vollzeit

Zusammenfassung

Syneos Health, Inc. is seeking a Senior Clinical Trial Manager to oversee end-to-end global trials across multiple regions, including Latin America.

You will ensure delivery against regulatory requirements, timelines and budgets, coordinating with cross-functional teams and external partners. The role requires a bachelor's degree in health care or science, 8+ years of clinical research/monitoring experience, and 3+ years of regional/global trial management, with strong knowledge of GCP/ICH

Qualifikationen

• Bachelor's degree in health care or other scientific discipline.
• 8 years clinical research/monitoring experience or equivalent.
• Minumun 3 years of regional/global trial management experience in the pharmaceutical industry or CRO.
• In-depth knowledge of GCP and ICH guidelines.
• Nice to have Cell Therapy/Hemayology TA experience.

Aufgaben

• Ensure clinical delivery of assigned projects in compliance with regulatory requirements (ICH-GCP, protocol), customer requirements (contract), and internal requirements (SOPs, project plans).
• Accountable for meeting projects' recruitment targets and recruitment strategies.
• Contribute to development of project risk mitigation plan and manage clinical risks throughout lifecycle.
• Ensure clinical quality delivery by identifying quality standards, monitoring compliance, and overseeing quality issues.

Ausbildung

Bachelor's degree Health care or other scientific discipline

8 years clinical research/monitoring experience

3 years regional/global trial management experience

GCP/ICH guidelines knowledge

Cell Therapy/Hemayology TA experience (nice to have)

Jobbeschreibung

Sr Clinical Trial Manager - Global Studies

Mexico City, Mexico
Santiago, Chile
Panama City, Panama
Buenos Aires, Argentina
San Jose, Costa Rica
São Paulo, Brazil
Bogota, Colombia
Full time
R
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.
• Nice to have Cell Therapy/Hemayology TA experience.
• Requires good knowledge of project finances.
• Knowledge of clinical trials - Knowledge of clinical trial conduct, and skill in applying applicable clinical research regulatory requirements i.e. International Conference on Harmonization (ICH) and Good Clinical Practice (GCP) and relevant local laws, regulations and guidelines, towards clinical trial conduct.