Sr/CRA Late Phase- Sweden
- May perform site selection, start-up/regulatory, initiation, monitoring and close out visits in accordance with contracted scope of work, using good clinical practices applicable regulations, SOPs and work instructions.
- Complete appropriate therapeutic, protocol and clinical research training to perform job duties.
- Work collaboratively with other functional groups such as Project Management, Regulatory Start-Up (RSU) and Epidemiology.
- Administer protocol and related study training to assigned sites and establish regular lines of communication with sites to manage ongoing project expectations and issues.
- Evaluate the quality and integrity of study site practices related to the proper conduct of the protocol and adherence to applicable regulations. Escalate quality issues to Clinical Project Manager (CPM), Site Management Lead (SML) and/or line manager.
- Execute assigned work efficiently and adhere to project timelines and financial goals;
- Manage the progress of assigned studies by documenting regulatory submissions and approvals, recruitment and enrolment, Case Report Form (CRF) completion and submission, and data query generation and resolution.
- May assist in preparation for in-house audits and in creation of Corrective Action Plans (CAPAs).
- Create and maintain appropriate documentation regarding site management, monitoring visit findings and action plans by submitting regular visit reports, generating follow-up letters, essential document collection and filing and other required study documentation.
- May provide assistance to less experienced clinical staff, including demonstrating appropriate interactions with sites, documentation and other monitoring activities.
REQUIRED KNOWLEDGE, SKILLS AND ABILITIES
- Interest in clinical research, you might have touched upon clinical research earlier on in your career.
- An education within healthcare or equivalent experience in the healthcare sector, pharmaceutical industry or CRO
- Knowledge to applicable clinical research regulatory requirements; i.e., Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines is an advantage
- Strong written and verbal communication skills in applicable languages, and business level command of English
- Strong organizational, interpersonal and problem-solving skills
- Strong attention to detail
- Computer skills including proficiency in use of Microsoft Word, Excel and PowerPoint
- Working time management skills
- Ability to establish and maintain effective working relationships with coworkers, managers and clients and site personnel at assigned sites
- Ability to travel – approximately 40% of working time in average.
MINIMUM REQUIRED EDUCATION AND EXPERIENCE
- Degree in life science or an education as nurse, pharmacy assistant or similar education
- Fluent in Swedish and English language skills
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 67,000+ employees around the world who apply their insight, curiosity and intellectual courage every step of the way. Learn more at jobs.iqvia.com.
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