Site Activation Specialist
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What you'll do
- Serve as the primary point of contact (SPOC) for investigative sites during feasibility and site activation activities.
- Coordinate site start-up and maintenance activities in compliance with local and international regulations, SOPs, and project requirements.
- Prepare, review, and manage essential site documentation, ensuring accuracy, completeness, and compliance.
- Track and follow up on regulatory, ethics, and contractual submissions and approvals.
- Review and support the execution of key study documents, including: Confidential Disclosure Agreements (CDAs), Feasibility Questionnaires, Regulatory submissions, Ethics Committee documentation, Informed Consent Forms (ICFs), Investigator Pack release documents
- Maintain study tracking systems, databases, timelines, and project documentation.
- Communicate document completion and activation milestones to project teams and stakeholders.
- Support contract and regulatory processes to ensure timely site activation.
- Partner closely with Site Activation Managers, Clinical Operations teams, Project Managers, and other internal stakeholders.
What they're looking for
- Bachelor's Degree in Life Sciences, Healthcare, Pharmacy, Nursing, Biology, or a related field.
- 1-3 years of clinical research, site activation, regulatory affairs, clinical operations, or related healthcare experience.
- Alternatively, an equivalent combination of education, training, and relevant experience.
- Romanian: Native
- English: Advanced (written and spoken)
Nice to have
- Approximately 3 years of experience within a healthcare, pharmaceutical, CRO, or clinical research environment.
- Experience working with site activation, regulatory submissions, clinical trial documentation, or site management activities.
- Strong organizational skills and attention to detail.
- Ability to manage multiple priorities and meet deadlines in a fast-paced environment.
- Excellent communication and stakeholder management skills.
Summarised by NextRaise from the employer’s description, which follows in full below.
Full description from employer
Site Activation Specialist (Romania)
Location: Romania (Hybrid)
Job Type: Full-time
Join IQVIA and Help Advance Clinical Research
IQVIA is seeking a Site Activation Specialist to support clinical research studies across Romania. In this role, you will be responsible for executing site activation, regulatory, and start-up activities while working closely with investigative sites, project teams, and sponsors. This is an excellent opportunity for professionals with experience in clinical research who are looking to grow their careers in a dynamic, international environment.
What You'll Do
As a Site Activation Specialist, you will:
- Serve as the primary point of contact (SPOC) for investigative sites during feasibility and site activation activities.
- Coordinate site start-up and maintenance activities in compliance with local and international regulations, SOPs, and project requirements.
- Prepare, review, and manage essential site documentation, ensuring accuracy, completeness, and compliance.
- Track and follow up on regulatory, ethics, and contractual submissions and approvals.
- Review and support the execution of key study documents, including:
- Confidential Disclosure Agreements (CDAs)
- Feasibility Questionnaires
- Regulatory submissions
- Ethics Committee documentation
- Informed Consent Forms (ICFs)
- Investigator Pack release documents
- Maintain study tracking systems, databases, timelines, and project documentation.
- Communicate document completion and activation milestones to project teams and stakeholders.
- Support contract and regulatory processes to ensure timely site activation.
- Partner closely with Site Activation Managers, Clinical Operations teams, Project Managers, and other internal stakeholders.
What We're Looking For
Required Qualifications
- Bachelor's Degree in Life Sciences, Healthcare, Pharmacy, Nursing, Biology, or a related field.
- 1-3 years of clinical research, site activation, regulatory affairs, clinical operations, or related healthcare experience.
- Alternatively, an equivalent combination of education, training, and relevant experience.
Preferred Experience
- Approximately 3 years of experience within a healthcare, pharmaceutical, CRO, or clinical research environment.
- Experience working with site activation, regulatory submissions, clinical trial documentation, or site management activities.
- Strong organizational skills and attention to detail.
- Ability to manage multiple priorities and meet deadlines in a fast-paced environment.
- Excellent communication and stakeholder management skills.
Language Requirements
- Romanian: Native
- English: Advanced (written and spoken)
What We Offer
- Hybrid working model.
- Opportunity to work on international clinical research projects.
- Professional development and career growth within a global organization.
- Collaborative and inclusive work environment.
- Competitive compensation and benefits package.
If you are passionate about clinical research and want to contribute to bringing innovative therapies to patients worldwide, we would love to hear from you. Apply today!
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.
Company
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