IQVIA™ is the leading human data science company focused on helping healthcare clients find unparalleled insights and better solutions for patients. Formed through the merger of IMS Health and Quintiles, IQVIA offers a broad range of solutions that harness the power of healthcare data, domain expertise, transformative technology, and advanced analytics to drive healthcare forward.
Under supervision of the line manager, negotiate Contracts, work on the Budgets, and review / process Informed Consent Forms. Coordinate for the completion and submission of Regulatory Packets on behalf of the Qcare Network Sites. Also track & present metrics and study information to the Client Site leadership - on a monthly basis.
• Serve as Single Point of Contact (SPOC) on assigned studies for Qcare Network Central and Site Teams. Ensure adherence to standard operating procedures (SOPs), work instructions (WIs), quality of designated deliverables and project timelines. Where applicable, act as a Country Lead for projects where no regional lead is assigned.
• Perform Regulatory, Start-up and Maintenance 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.
• Review, prepare and negotiate site contracts and budgets with CRO's and Sponsors.
• Ensure accurate completion and maintenance of internal systems, databases and tracking tools - with project specific information.
• Ensure contracts are fully executed, the regulatory documents & approvals are granted and the specific project deliverables are completed.
• Review and provide feedback to management on site performance metrics.
• May provide input into contract and budget template development.
• May have direct contact with sponsors and/or clients on specific initiatives.
• May act as Local Regulatory, Ethics and Contract Expert and reviewer of ICF.
• May participate in feasibility and/or site identification activities.
MINIMUM REQUIRED EDUCATION AND EXPERIENCE
To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required.
Typically requires 2+ years of prior relevant experience.
Requires intermediate level knowledge of principles, theories, and concepts of a job area, typically obtained through advanced education combined with experience.
Bachelor's Degree in life sciences or a related field and 3 years of clinical research or other relevant experience; or equivalent combination of education, training and experience.
SKILLS and ABILITIES
- 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.
Making a positive impact on human health takes insight, curiosity, and intellectual courage. It takes brave minds, pushing the boundaries to transform healthcare. Regardless of your role, you will have the opportunity to play an important part in helping our clients drive healthcare forward and ultimately improve outcomes for patients.
Forge a career with greater purpose, make an impact, and never stop learning.
IQVIA is an EEO Employer - Minorities/Females/Protected Veterans/Disabled
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 firstname.lastname@example.org to arrange for such an accommodation.
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