in accordance with applicable local and / or international regulations, standard operating procedures (SOPs), project requirements and contractual / budgetary guidelines.
May also include maintenance activities.
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 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 regulatory 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 regulatory and contractual documents for individual sites.
Review, track and follow up the progress, the approval and execution of documents, 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.
Bachelor's Degree Related field Req
1 year clinical research experience. Equivalent combination of education, training and experience.
In-depth knowledge of clinical systems, procedures, and corporate standards
Strong knowledge of medical terminology and regulations
Broad knowledge of clinical research
Strong knowledge of Microsoft Office and e-mail applications
Effective communication, organizational, and interpersonal skills
Ability to work independently and to effectively prioritize tasks
Ability to manage multiple projects
Attention to detail
Ability to establish and maintain effective working relationships with coworkers, managers and clients.
At IQVIA, we believe in pushing the boundaries of human science and data science to make the biggest impact possible to help our customers create a healthier world.
The advanced analytics, technology solutions and contract research services we provide to the life sciences industry are made possible by our 67,000+ employees around the world who apply their insight, curiosity and intellectual courage every step of the way.