Reg & Start-Up Spec 2 at IQVIA (Raleigh, NC)

| Raleigh-Durham, NC
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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.

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 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.

Qualifications• Bachelor's Degree Bachelor's Degree in life sciences or a related field and 3 years' clinical research or other relevant experience; or equivalent combination of education, training and experience.• 3 years clinical research experience, including 1 year experience in a leadership capacity. 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.• Ability to manage multiple projects.• Knowledge and ability to apply GCP/ICH and applicable regulatory guidelines.• Knowledge of applicable regulatory requirements, including local regulations, , SOPs and company's 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.

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 70,000+ employees around the world who apply their insight, curiosity and intellectual courage every step of the way. Learn more at jobs.iqvia.com.

All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, status as a protected veteran, or any other status protected by applicable law.

IQVIA, Inc. provides reasonable accommodations for applicants with disabilities. Applicants who require reasonable accommodation to submit an application for employment or otherwise participate in the application process should contact IQVIA's Talent Acquisition team at [email protected] to arrange for such an accommodation.
More Information on IQVIA
IQVIA operates in the Healthtech industry. The company is located in Durham, NC. IQVIA was founded in 2016. It has 61500 total employees. It offers perks and benefits such as Flexible Spending Account (FSA), Disability Insurance, Dental Benefits, Vision Benefits, Health Insurance Benefits and Life Insurance. To see all 254 open jobs at IQVIA, click here.
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