Join us on our exciting journey! IQVIA™ is The Human Data Science Company™, focused on using data and science to help healthcare clients find better solutions for their patients.
Formed through the merger of IMS Health and Quintiles, IQVIA offers a broad range of solutions that harness advances in healthcare information, technology, analytics and human ingenuity to drive healthcare forward.
A Central Monitor (CM) is a key skilled and clinically experienced team member of IQVIA Central Monitoring Department. A CM provides remote project support and assistance across multiple projects, sites and teams and reviews the structured clinical data output with access to medical charts.
Perform centralized monitoring activities on assigned projects and evaluate the quality and integrity of the study as per the protocol, Standard Operating Procedures (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 study(ies).
May assist in developing required basic data analytics scope and performing the trend analytics for their respective study(ies).
May participate in 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. Central 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 Central Monitor Expert / Centralized Monitoring Lead
REQUIRED KNOWLEDGE, SKILLS AND ABILITIES
Knowledge of clinical trial conduct, and skill in applying applicable clinical research regulatory requirements; i.e., ICH GCP and relevant local laws, regulations and guidelines, towards clinical trial conduct.
Familiarity with related systems and software utilized in clinical operations.
Strong written and verbal communication skills of English language
Results and detail-oriented approach to work delivery and output
Ability to work on multiple projects and manage competing priorities
Ability to establish and maintain effective working relationships
Good planning, time management and prioritization skills
Good software and computer skills, including MS Office applications including but not limited to Microsoft Word, Excel and PowerPoint
Ability to work across cultures and geographies with a high awareness and understanding of cultural differences
MINIMUM REQUIRED EDUCATION AND EXPERIENCE
You must have a Bachelor's degree in life sciences or related field, or nursing qualification; or be near to obtain the degree or equivalent combination of education, training and experience.
At least 2 years of relevant clinical research experience
Advanced English Level.
We know that meaningful results require not only the right approach but also the right people. Regardless of your role, we invite you to reimagine healthcare with us.
You will have the opportunity to play an important part in helping our clients drive healthcare forward and ultimately improve human health outcomes.
Whatever your career goals, we are here to ensure you get there! We invite you to join IQVIA™
Job ID : R1055616