Study Start Up Support (Europe, Homebased) - IQVIA Biotech
Job Details
Full Job Description
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 B.A./B.S.
preferably in a business or science/health care field, nursing degree,
or equivalent degree
• One year of prior experience in a client
service role at a biotechnology or pharmaceutical company, CRO, or
other organization supporting clinical research or healthcare
activities. Basic knowledge of the clinical trial process.
•
Analytical Thinking: Tackle problems by using a logical, systematic,
sequential approach
• Attention to Communication: The ability to
ensure that information is passed on to others who should be kept
informed
• Fostering Teamwork: The ability and desire to work
cooperatively with others on a team
• Customer Orientation: The
ability to demonstrate concern for satisfying one’s external and/or
internal customers
• Initiative: Identifying what needs to be done
and doing it before being asked or before the situation requires
it
• Oral Communication: The ability to express oneself clearly in
conversations and interactions with others
• Thoroughness:
Ensuring that one’s own and others’ work and information are complete
and accurate
• Written Communication: The ability to express
oneself clearly in business writing
• Supervisory
Responsibilities
This position does not have responsibility for
managing people.
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 .