Study Start Up & Regulatory Associate
- Experience Level
- Experienced (non-manager)
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.
Clinical FSP Business
IQVIA clinical FSP business is unique. Our teams are dedicated to a single sponsor partner, where the common goal is quality delivery for our clients. In this case you will be working with a global top 10 pharmaceutical partner, focused mostly on developing cancer treatments. We set ourselves apart with collaboration and face to face contact both at start up and during the clinical study.
Leadership recognises the skills, talent and experience of our clinical teams and strives to build upon this as the function evolves and grows. Our managers understand the sponsors priorities and the individual aspects of each model. Focus is given to career development from day one, including new hire orientation and onboarding, day to day problem solving and training and development.
The CFSP RSU specialist performs 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. it may also include maintenance activities.
What we Offer:
- Excellent salary and benefits package
- We invest in keeping our teams stable, so workload is consistent
- We offer genuine career development opportunities for those who want to grow as part of the organisation
- 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
Become part of our team.
We believe in hiring the best talent in the industry.
To become part of our team, you should:
- 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.
- up to 3 years clinical research experience. Preferably within Study Start Up. 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 co-workers, managers and clients.
- Whatever your career goals, we are here to ensure you get there!
We invite you to join IQVIA™.
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. Learn more at jobs.iqvia.com.
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.