Centralized Monitor - Centurion & Cape Town 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.
- Perform Centralized Monitoring activities on assigned projects and evaluate the quality and integrity of the study as per the protocol, SOPs respective regulation and guidelines.
- Ensure accurate completion and maintenance of internal systems, databases, tracking tools/reports for the project specific information.
- May perform Management of triggers and preparation of i-site pack for respective sites and countries for assigned studies.
- May assist in Developing required basic data analytics scope and performing the trend analytics for their respective studies.
- May participate in (study) team meetings and interaction with cross functional staff to verify information and/or triage new data issues or prior identified action items
- Escalate quality issues pertaining to site to respective Centralized monitoring lead/ Sr. Centralized Monitor.
- May perform Subject Level Data Review that require further investigation with the clinical site to determine overall accuracy (inclusion & exclusion criteria/ IP/AE/ Labs/EOT/EOS/ End points/SAEs etc.)
- Review any other information as necessary to determine overall readiness of the patient information for next level review
- Interaction with sites/CRA and follow-up on study required milestones from the project start until close out.
- May act as backup/ perform the activities as per the task list delegated by Centralized Monitor Expert/Centralized Monitoring Lead
REQUIRED KNOWLEDGE, SKILLS AND ABILITIES
- Good knowledge of applicable clinical research regulatory requirements; i.e., ICH GCP and relevant local laws,
regulations and guidelines
- Strong written and verbal communication skills including good command of English language
- Results and detail-oriented approach to work delivery and output
- Good problem-solving skills
- Good planning, time management and prioritization skills
Attention to detail and accuracy in work
- Good software and computer skills, including MS Office applications including but not limited to Microsoft Word, Excel and PowerPoint
- Ability to establish and maintain effective working relationships with co-workers, managers and clients.
Proven ability to work on multiple projects balancing competing priorities
- Ability to coach/ mentor junior colleagues
MINIMUM REQUIRED EDUCATION AND EXPERIENCE
- Bachelor's degree in life sciences or related field, or nursing qualification; or be near to obtaining the degree.
- At least 2 years of relevant clinical research experience
- Extensive use of telephone and face to face communication requiring accurate perception of speech
- Extensive use of keyboard requiring repetitive motion of fingers
- Regular sitting for extended periods of time
- May be required to work in shifts
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.