Site Manager 1, Real World Evidence (RWE)
IQVIA Holdings Inc.
Primary Location: Sao Paulo, São Paulo, Brazil
Additonal Locations: Bogota, Colombia,COL; Mexico City, Mexico,MEX
Join us as a RWE Site Manager 1!
What You´ll DoMay perform site selection, start-up/regulatory, initiation, monitoring and close out visits in accordance with contracted scope of work, using good clinical practices applicable regulations, SOPs and work instructions
Complete appropriate therapeutic, protocol and clinical research training to perform job duties.
Work collaboratively with other functional groups such as Project Management, Regulatory Start-Up (RSU) and Epidemiology.
Administer protocol and related study training to assigned sites and establish regular lines of communication with sites to manage ongoing project expectations and issues.
Evaluate the quality and integrity of study site practices related to the proper conduct of the protocol and adherence to applicable regulations. Escalate quality issues to Clinical Project Manager (CPM), Site Management Lead (SML) and/or line manager.
Execute assigned work efficiently and adhere to project timelines and financial goals.
Manage the progress of assigned studies by documenting regulatory submissions and approvals, recruitment and enrollment, Case Report Form (CRF) completion and submission, and data query generation and resolution.
Create and maintain appropriate documentation regarding site management, monitoring visit findings and action plans by submitting regular visit reports, generating follow-up letters, essential document collection and filing and other required study documentation.
May provide assistance to less experienced clinical staff, including demonstrating appropriate interactions with sites, documentation and other monitoring activities.
What Will Help You SucceedGraduated or currently pursuing a Bachelor´s Degree.
1 year of relevant clinical research experience.
Written and verbal communication skills including good command of English language.
Computer skills including working knowledge of Microsoft Word, Excel and PowerPoint.
Effective time management and organizational skills.
Ability to establish and maintain effective working relationships with coworkers, managers, and clients.
May perform site selection, start-up/regulatory, initiation, monitoring and close out visits in accordance with contracted scope of work, using good clinical practices applicable regulations, SOPs and work instructions
Complete appropriate therapeutic, protocol and clinical research training to perform job duties.
Work collaboratively with other functional groups such as Project Management, Regulatory Start-Up (RSU) and Epidemiology.
Administer protocol and related study training to assigned sites and establish regular lines of communication with sites to manage ongoing project expectations and issues.
Evaluate the quality and integrity of study site practices related to the proper conduct of the protocol and adherence to applicable regulations. Escalate quality issues to Clinical Project Manager (CPM), Site Management Lead (SML) and/or line manager.
Execute assigned work efficiently and adhere to project timelines and financial goals.
Manage the progress of assigned studies by documenting regulatory submissions and approvals, recruitment and enrollment, Case Report Form (CRF) completion and submission, and data query generation and resolution.
Create and maintain appropriate documentation regarding site management, monitoring visit findings and action plans by submitting regular visit reports, generating follow-up letters, essential document collection and filing and other required study documentation.
May provide assistance to less experienced clinical staff, including demonstrating appropriate interactions with sites, documentation and other monitoring activities.
Graduated or currently pursuing a Bachelor´s Degree.
1 year of relevant clinical research experience.
Written and verbal communication skills including good command of English language.
Computer skills including working knowledge of Microsoft Word, Excel and PowerPoint.
Effective time management and organizational skills.
Ability to establish and maintain effective working relationships with coworkers, managers, and clients.
*Please submit your CV in English*
Job posted: 2023-11-21
