Senior Site Activation Coordinator
5 months ago
IQVIA’s Country Site Activation team are a global network who identify and activate sites to the highest quality to ensure patients on Clinical trials have access to safe and effective medication. We are leaders in innovation and first to new technologies meaning a vast amount of career development opportunities are available.
As Senior Site Activation Coordinator, under general supervision you will perform tasks at a country level associated with site activation activities. These activities will be in accordance with applicable local and/or international regulations, standard operating procedures (SOPs), project requirements and contractual/budgetary guidelines. Your task may also include maintenance activities.
- Perform feasibility, site activation and some maintenance activities in assigned studies for investigative sites, according to applicable regulations, SOPs and work instructions, working closely with the Site Activation Manager (SAM), Project Management team, and other departments as necessary
- Review documents for completeness, consistency and accuracy, under guidance of senior staff
- Prepare site documents, reviewing for completeness and accuracy
- Review, track and follow up the progress, the approval and execution of required documents such as questionnaires, CDAs, regulatory, ethics, Informed Consent Form (ICF) and Investigator Pack (IP) release documents
- Inform team members of completion of regulatory contractual and other documents for individual sites
- Distribute completed documents to sites and internal project team members
- Support the updating and maintenance of internal systems, databases, tracking tools, timelines and project plans with accurate and complete project specific information
REQUIRED KNOWLEDGE, SKILLS AND ABILITIES
- Bachelor’s Degree in Life Science or related field preferred
- Minimum 2 years’ work experience; 1+ years in healthcare or similar considered advantageous
- Fluent/ native language capabilities, including English
- Works under general supervision and delivers objectives that significantly impact results for a job area
- Good interpersonal communication and organizational skills to establish and maintain effective working relationships with co-workers, managers and sponsors
- Ability to handle change and ambiguity
- Ability to work on multiple projects
- General awareness of clinical trial environment and drug development process advantageous
- German language abilities A2/B1
NICE TO HAVE
- Contract negotiations experience
- EU-CTR submission experience
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