- Location
- Sofia, Bulgaria
- Type
- Internship
- Seniority
- Internship
- Source
- Workday
Description
Job Description Summary
An excellent opportunity for students eager to launch their Clinical Research careers while gaining practical experience in Clinical Trial Agreement support, Contract Negotiation processes, and Country Site Activation activities.
Key Responsibilities
The intern will support Contract Negotiators (CNs) and other Country Site Activation (CSA) team roles with entry-level, lower-complexity, administrative, and operational activities, including:
• Support Contract Negotiator activities under guidance and supervision.
• Assist with contract customization based on approved templates and sponsor/site requirements.
• Support alignment and mirroring of legal and budget wording between studies, where applicable and under supervision.
• Support document preparation, formatting, handling, and filing.
• Support sending documents to sites and tracking site responses.
• Assist with initiating e-signature workflows and following up on completion status.
• Support tracking, follow-up activities, and maintenance of internal trackers, where appropriate.
• Help prepare shipments to investigator sites.
• Support regulatory document collection, site staff list updates, and study file organization.
• Learn how to work with clinical systems such as SAW, CTMS, eTMF, and study portals as applicable to the assigned activities and access rights.
Training & Onboarding
• Participate in a structured onboarding program covering Clinical Research, ICH-GCP, Country Site Activation processes, Clinical Trial Agreements, CTA budget basics, and required professional skills.
• Complete assigned learning modules and attend team-led trainings, workshops, and knowledge-sharing sessions.
• Build a foundational understanding of the purpose, structure, and key provisions of Clinical Trial Agreements (CTAs).
• Learn how to review, interpret, and manage CTA documents throughout the contract lifecycle at a basic/support level.
• Learn Fair Market Value (FMV) principles and their application in clinical trial budgeting and negotiations.
• Gain understanding of CTA budget components, payment schedules, and financial considerations.
• Gain exposure to CTA negotiation principles and best practices through training, observation, and supervised practical examples.
• Strengthen verbal and written communication skills in professional business environments.
• Apply acquired knowledge through practical examples, case studies, document reviews, and negotiation exercises.
CN/CSA Role Shadowing & Team Collaboration
• Shadow experienced CNs and CSA Specialists to observe daily responsibilities and decision-making in real study environments.
• Gain exposure to site activation planning and execution, contract negotiation and finalization processes, and coordination with Regulatory, Legal, Finance, and Clinical Operations stakeholders to support study start-up objectives.
• Support ongoing operational activities related to contract execution, site activation, and study start-up deliverables.
• Participate in team meetings, study-related discussions, and cross-functional interactions to develop an understanding of CSA and CN operational workflows.
Qualifications
• Currently pursuing a Bachelor’s or Master’s degree, preferably in Finance and/or Law
• Appropriate verbal and written communication skills to function within a professional work environment.
• Good attention to detail and ability to work with structured documents, trackers, and administrative processes.
• Good organizational skills and ability to manage assigned tasks within agreed timelines.
• Interest in Clinical Research, contract management, site activation, or clinical trial start-up activities.
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.