CSA Specialist
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Job Location:
Copenhagen - Denmark
Monthly Salary:
Not Disclosed
Posted on:
12 hours ago
Vacancies:
1 Vacancy
Job Summary
Site Activation Specialist
Location: Denmark
Work Model: Hybrid
Job Overview
Under moderate supervision the Site Activation Specialist is responsible for executing feasibility site identification regulatory site startup and maintenance activities at the regional or country level. This role ensures compliance with applicable regulations SOPs and project requirements.
The Site Activation Specialist prepares and manages site documentation; reviews negotiates and tracks regulatory and site-related documents; maintains site performance metrics; and serves as the primary point of contact for investigative sites. The role also supports the establishment of project timelines and ensures that contracts and essential documents are fully executed in line with budgetary and contractual guidelines.
Essential Functions
- Serve as a Single Point of Contact (SPOC) for assigned studies performing feasibility site activation and selected maintenance activities for investigative sites under moderate oversight.
- Work closely with the Site Activation Manager (SAM) Project Management and crossfunctional teams to support site startup and ongoing site activities.
- Prepare and review site documents for completeness accuracy and consistency with guidance from senior staff.
- Review track and follow up on the collection approval and execution of key documents including:
- Feasibility questionnaires
- Confidential Disclosure Agreements (CDAs)
- Regulatory and ethics submissions
- Informed Consent Forms (ICFs)
- Investigator Pack (IP) release documentation
- Communicate status updates and completion of regulatory contractual and other site-level documentation to project team members.
- Distribute approved and completed documents to investigative sites and internal stakeholders.
- Update and maintain internal systems databases trackers timelines and project plans with accurate and timely study information.
- Support site performance tracking and ensure adherence to applicable local and international regulations SOPs and work instructions.
Qualifications
- Bachelors degree in Life Sciences or a related field (required).
- 13 years of experience in clinical research or a relevant healthcare-related role or an equivalent combination of education training and experience (required).
- Up to 3 years of experience in a healthcare or clinical research environment or equivalent experience (preferred).
- Strong understanding of clinical trial processes regulatory requirements and GCP principles.
- Excellent organizational skills with strong attention to detail and the ability to manage multiple priorities.
- Native or fluent Danish (required).
- Fluent English both written and spoken (required).
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
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.
Required Experience:
IC
Key Skills
About Company
IQVIA is the Human Data Science Company™. We are inspired by the industry we serve and provide solutions that enable life sciences companies to innovate with confidence, maximize opportunities and ultimately drive human health outcomes forward. Our approach is Human Data Science – a d ... View more
