Site Management Coordinator (Cape Town, Centurion or Bloemfontein based)
IQVIA Holdings Inc.
Irene, South Africa
IQVIA™ is the leading human data science company focused on helping healthcare clients find unparalleled insights and better solutions for patients. Formed through the merger of IMS Health and Quintiles, IQVIA offers a broad range of solutions that harness the power of healthcare data, domain expertise, transformative technology, and advanced analytics to drive healthcare forward.
Under general supervision, perform tasks at a country level associated with site activation activities in accordance with applicable local and/or international regulations, standard operating procedures (SOPs), project requirements and contractual/budgetary guidelines. May also include maintenance activities.
Under general supervision, perform site activation 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 regulatory documents, reviewing for completeness and accuracy.
Inform team members of completion of regulatory and contractual 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.
Review, track and follow up the progress, the approval and execution of documents, regulatory, ethics, Informed Consent Form (ICF) and Investigator Pack (IP) release documents.
- Assist the team in the preparation, handling, distribution, filing and archiving of documentation according to the scope of work and standard operating procedures.
- Prepare client deliverable documents using appropriate tools and may draft text for straightforward documents, under guidance of senior staff.
- Assist with completion of relevant Clinical Trial Management System (CTMS) fields, databases, tracking tools, timelines and project plans with project specific information.
- Provide support for administrative tasks, e.g. meeting coordination, minute taking, travel arrangements, faxing, copying, couriers.
- Interact with internal and external clients, under guidance of senior staff.
- May perform IP release activities on small, straightforward projects or support reviews for larger projects.
REQUIRED KNOWLEDGE, SKILLS AND ABILITIES
- Good interpersonal communication and organizational skills.
- Good word processing skills and knowledge of MS Office applications.
- Good attention to detail.
- General awareness clinical trial environment and drug development process.
- Ability to work on multiple projects.
- Ability to establish and maintain effective working relationships with co-workers, managers and sponsors.
MINIMUM REQUIRED EDUCATION AND EXPERIENCE
- Grade 12 and 2 years' clinical research, administrative or other relevant experience; or equivalent combination of education, training and experience.
Requires basic job knowledge of systems and procedures obtained through prior work experience or education.
Making a positive impact on human health takes insight, curiosity, and intellectual courage. It takes brave minds, pushing the boundaries to transform healthcare. Regardless of your role, you will have the opportunity to play an important part in helping our clients drive healthcare forward and ultimately improve outcomes for patients.
Forge a career with greater purpose, make an impact, and never stop learning.