Country Study Operations Manager I (Posadas)

Country Study Operations Manager I (Posadas)

26 may
|
Parexel
|
Posadas

26 may

Parexel

Posadas

Parexel FSP is looking for a Country Study Operations Manager I Candidates can be based anywhere in Brazil, Mexico or Argentina and must have experience with US and Canada

Job Summary
The Country Study Operations Manager I (cSOM I) has responsibilities for study and specific country level activities from study startup through conduct and study close on studies of limited complexity (a small number of countries/sites) or manages portions of a larger study (such as recruitment and retention).

Key Accountabilities
Study Management Oversight
- Supports Integral Study Managers (GSMs), other SOMs, and the larger study management delivery of the study by leading specific parts of the project, driving specific countries, executing tasks of moderate complexity, and developing solutions to problems as needed to support deliverables
- Serves as leader of the local study team (core members, ad hoc members, and other key stakeholders as required) on one or more studies
- Oversees the preferred Contract Research Organization (pCRO) and/or Country Trial Manager (CTM)/Site Care Partner (SCP)



for assigned studies at country level in accordance with the overall project plan, and manages and maintains accurate country level plans (e.g., timelines, budget, risk, and quality plans)
- May manage the study start up process in countries assigned [where the Start Up Project Manager (SUPM) is not assigned] and/or oversee the pCRO responsible for these activities as applicable
- Liaises with SCP, Lead SCP, Site Activation Partners (SAPs), and regulatory colleagues in country to agree on submission strategy to Health Authorities (HAs) and Ethic Committees (ECs)
- Provides country level input on startup and recruitment milestones as provided by pCRO and/or CTM/SCP to GSM during planning
- Collaborates with accountable roles to identify and manage deviations and risks in study startup and execution and implements mitigation strategies as required. Accountable for resolution of site activation es

📌 Country Study Operations Manager I (Posadas)
🏢 Parexel
📍 Posadas

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