Site Activation Specialist, ICF Lead
About the role
Site Activation Specialist, ICF Lead
Site Activation (SA)
local and regional expertise
Essential Functions
- Under general supervision, act as the
Single Point of Contact (SPOC)
for assigned studies, collaborating with investigative sites, Site Activation Managers (SAMs), Project Management teams, and other internal stakeholders
- Ensure compliance with
local regulations
, SOPs, Work Instructions (WIs), quality standards, and agreed project timelines
- Perform
feasibility assessments, site identification, study start-up, and site activation activities
in line with regional regulatory requirements
- Prepare, review, and distribute site documentation, ensuring completeness, accuracy, and timeliness
- Maintain accurate and up-to-date information in
internal systems, databases, and tracking tools
- Review site performance metrics and provide insights and feedback to management
- Review, establish, and align on
project plans and timelines
, ensuring monitoring measures and contingency plans are implemented when needed
- Communicate completion of feasibility, site identification, regulatory, and contractual milestones to relevant project team members
- Review, track, and follow up on the progress, approval, and execution of study documents, including: • Confidential Disclosure Agreements (CDAs)
- Site Information Forms (SIFs)
- Regulatory and ethics submissions
- Informed Consent Forms (ICFs)
- Investigator Packs (IPs) and IP release documentation
- Provide
local regulatory and operational expertise
to SAMs and project teams during start-up and throughout study execution
- Perform
quality control reviews
of documentation received from investigative sites
- Maintain limited and appropriate
direct sponsor contact
Qualifications
- Bachelor's degree in
Life Sciences or a related field
(required)
- Minimum of
3 years of clinical research or relevant experience
, or an equivalent combination of education, training, and experience
- Strong understanding of
country-specific regulatory requirements
within one or more of the listed locations
- Demonstrated ability to manage multiple priorities, meet deadlines, and work cross-functionally
- Strong communication skills, attention to detail, and problem-solving mindset
IQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create intelligent connections to accelerate the development and commercialization of innovative medical treatments to help improve patient outcomes and population health worldwide. Learn more at https://jobs.iqvia.com
IQVIA is committed to integrity in our hiring process and maintains a zero tolerance policy for candidate fraud. All information and credentials submitted in your application must be truthful and complete. Any false statements, misrepresentations, or material omissions during the recruitment process will result in immediate disqualification of your application, or termination of employment if discovered later, in accordance with applicable law. We appreciate your honesty and professionalism.
Not included in the source posting: about the role, benefits.
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