Study & Start Up Specialist - MADRID
IQVIA Holdings Inc.
Join us in our exciting journey!!
A career with IQVIA connects you to great opportunity to achieve professional success and impact healthcare around the world.
With a fantastic work/life balance, this is a great opportunity for a Study & Start-up Specialist willing to to discover how a true partnership between different parties works!
The role: Duties and Responsibilities
Under the guidance of the EU Study Start-Up Manager of Global Clinical Study Support, this position will be responsible for conducting end-to-end site start-up from feasibility to site activation serving as the primary point of contact for the site and the study team. This includes supporting site level feasibility assessments, coordinating site identification at a country and regional level, supporting site qualification, and site start-up activities.
- Serve as primary point of contact to study team on end-to-end start up activity
- Participate in or lead Study Start-up team meetings as appropriate
- Utilize Study Start Up tools to track activities and develop reports
- Oversee Feasibility activities including the negotiation and collection of Confidential Disclosure Agreements and the collection and analysis of Feasibility Questionnaires
- Conduct site contract/budget negotiations (Confidentiality Agreement and Clinical Trial Agreements)
- Collect essential documents from sites, tracking & review led by Document Management Team
- Support the collection of country and site level intelligence
- Complete, manage and/or support Ethics Committee and Regulatory Authority submissions
- Where required, complete, manage and/or support country and site-specific activities (e.g., compiling, submitting and obtaining import/export licenses, radiation board and biobank committee approvals, etc.) required to activate sites for a clinical trial as appropriate
- Support the other SSU Specialists with the collection and review of Essential Documents for sites located in other countries
- Support the local clinical operations team with other trial-related tasks
Our ideal candidate: Skills & other requirements
- BA/BS degree in Science or related field.
- 3 years clinical research experience, including 1 year experience in a leadership capacity. Equivalent combination of education, training and experience is also considered.
- At least 5 years’ experience in site start-up and contract management in pharmaceutical company or in clinical research organization.
- Thorough knowledge of applicable regulations, drug development, and clinical trial management procedures.
- Strong presentation, documentation, and interpersonal skills.
- Proficient in MS Office (Word, Excel, and PowerPoint), MS Project, email, and Internet.
- Ability to handle multiple tasks to meet deadlines, delivering high quality work in a dynamic environment.
- Excellent oral and written communication skills.
- Proficient in Spanish and English
- Excellent planning and organizational skills with effective time management.
- Excellent interpersonal skills.
- Thorough understanding of country level cultural norms and local healthcare systems; ability to initiate and develop relationships with local investigators and key site personnel.
- Thorough understanding of clinical research principles and process.
- Thorough understanding of FDA and/ or EU Directives and regulations, ICH Guidelines and country/local regulatory requirements.
- Goal oriented, self-starter with proven ability to work independently;
- Ability to manage multiple tasks simultaneously and meet deliverables in accordance with stated timelines;
- Comfort with ambiguity; ability to act without having the total picture.
- Ability to proactively identify and solve problems.
- Flexibility and willing to provide cross-functional support.
We invite you to join IQVIA™
- Recognized by Great Place to Work as the second best company to work for in Spain (March 2019)
- FORTUNE Magazine's World's Most Admired Companies list for the third year in a row (June 2020)
- Recognized by the 2016 Scrip Awards as the Best Full-service Provider Contract Research Organization (CRO)
- Awarded the 2016 Eagle Award from the Society for Clinical Research Sites (SCRS) for the fourth consecutive year.
- A site-nominated award recognizing contract research organizations (CRO) and biopharmaceutical sponsors dedicated to building positive relationships with research sites through leadership, professionalism and integrity.
- IQVIA™ named in The International Association of Outsourcing Professionals (IAOP) 2017 Global Outsourcing 100® List which recognizes the world’s best service providers across a range of industries.
IQVIA™ is an equal opportunity employer. We make employment decisions based on qualifications and merit. We prohibit discrimination based on any unlawful consideration such as age, race, national origin, gender or other "protected status.“
We know that meaningful results require not only the right approach but also the right people. Regardless of your role, we invite you to reimagine healthcare with us. You will have the opportunity to play an important part in helping our clients drive healthcare forward and whatever your career goals, we are here to ensure you get there!
Are you interested or do you know the ideal candidate?
- If you know the right candidate or for more information on this role please contact [email protected]
- Please note is necessary that your application is registered in our Talent Network to process your candidacy
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.