Senior Site Activation Specialist or Site Activation Specialist

Hanoi - Vietnam

Monthly Salary: Not Disclosed

Posted on: 30+ days ago

Vacancies: 1 Vacancy

Job Summary

Job Overview
Perform tasks at a country level associated with Site Activation (SA) activities in accordance with applicable local and/or international regulations standard operating procedures (SOPs) project requirements and contractual/budgetary guidelines. May also include maintenance activities. Developing professional individual contributor who works under moderate oversight and supervision. Responsible for making recommendations for enhancements in systems and processes to solve problems or improve effectiveness of job area. Problems faced are general and may require understanding of broader set of issues but are not complex.

Essential Functions

Under general supervision serve as Single Point of Contact (SPOC) in assigned studies for investigative sites Site Activation Manager (SAM) Project Management team and other departments as necessary. Ensure adherence to standard operating procedures (SOPs) Work Instructions (WIs) quality of designated deliverables and project timelines.
Perform feasibility site ID start up and site activation activities according to applicable regulations SOPs and work instructions. Distribute completed documents to sites and internal project team members.
Prepare site documents reviewing for completeness and accuracy.
Ensure accurate completion and maintenance of internal systems databases and tracking tools with project specific information.
Review and provide feedback to management on site performance metrics.
Review establish and agree on project planning and project timelines. Ensure monitoring measures are in place and implement contingency plan as needed.
Inform team members of completion of fesibility site ID regulatory and contractual documents for individual sites.
Review track and follow up the progress the approval and execution of documents questionnaires CDA/SIF regulatory ethics Informed Consent Form (ICF) and Investigator Pack (IP) release documents in line with project timelines.
Provide local expertise to SAMs and project team during initial and on-going project timeline planning.
Perform quality control of documents provided by sites.
May have direct contact with sponsors on specific initiatives

Qualifications

Bachelors Degree in life sciences or a related field and 5 years clinical research or other relevant experience; or equivalent combination of education training and experience.
In-depth knowledge of clinical systems procedures and corporate standards.
Good negotiating and communication skills with ability to challenge if applicable.
Effective communication organizational and interpersonal skills.
Ability to work independently and to effectively prioritize tasks.
Knowledge and ability to apply GCP/ICH and applicable regulatory guidelines.
Knowledge of applicable regulatory requirements including local regulations SOPs and companys Corporate Standards.
Understanding of regulated clinical trial environment and knowledge of drug development process.
Ability to establish and maintain effective working relationships with coworkers managers and clients

#LI-Hybrid

IQVIA is a leading global provider of clinical research services commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create intelligent connections to accelerate the development and commercialization of innovative medical treatments to help improve patient outcomes and population health worldwide. Learn more at

Required Experience:

Senior IC

Job OverviewPerform tasks at a country level associated with Site Activation (SA) activities in accordance with applicable local and/or international regulations standard operating procedures (SOPs) project requirements and contractual/budgetary guidelines. May also include maintenance activities. D...

Essential Functions

Under general supervision serve as Single Point of Contact (SPOC) in assigned studies for investigative sites Site Activation Manager (SAM) Project Management team and other departments as necessary. Ensure adherence to standard operating procedures (SOPs) Work Instructions (WIs) quality of designated deliverables and project timelines.
Perform feasibility site ID start up and site activation activities according to applicable regulations SOPs and work instructions. Distribute completed documents to sites and internal project team members.
Prepare site documents reviewing for completeness and accuracy.
Ensure accurate completion and maintenance of internal systems databases and tracking tools with project specific information.
Review and provide feedback to management on site performance metrics.
Review establish and agree on project planning and project timelines. Ensure monitoring measures are in place and implement contingency plan as needed.
Inform team members of completion of fesibility site ID regulatory and contractual documents for individual sites.
Review track and follow up the progress the approval and execution of documents questionnaires CDA/SIF regulatory ethics Informed Consent Form (ICF) and Investigator Pack (IP) release documents in line with project timelines.
Provide local expertise to SAMs and project team during initial and on-going project timeline planning.
Perform quality control of documents provided by sites.
May have direct contact with sponsors on specific initiatives

Qualifications

Bachelors Degree in life sciences or a related field and 5 years clinical research or other relevant experience; or equivalent combination of education training and experience.
In-depth knowledge of clinical systems procedures and corporate standards.
Good negotiating and communication skills with ability to challenge if applicable.
Effective communication organizational and interpersonal skills.
Ability to work independently and to effectively prioritize tasks.
Knowledge and ability to apply GCP/ICH and applicable regulatory guidelines.
Knowledge of applicable regulatory requirements including local regulations SOPs and companys Corporate Standards.
Understanding of regulated clinical trial environment and knowledge of drug development process.
Ability to establish and maintain effective working relationships with coworkers managers and clients

#LI-Hybrid

Required Experience:

Senior IC

Key Skills

Business
Marketing
Key Decision Makers
Active Directory
Customer Service
Performance Evaluations
Federal Regulations
Communications
Account Management
Project Management
Facebook
Minimum Data Set
Budget management
Powerpoint
Direct Reports

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About Company

IQVIA

IQVIA is the Human Data Science Company™. We are inspired by the industry we serve and provide solutions that enable life sciences companies to innovate with confidence, maximize opportunities and ultimately drive human health outcomes forward. Our approach is Human Data Science – a d ... View more

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