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- Morrisville, NC
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Clinical Data Manager (Home-Based) - RSS
IQVIA • Morrisville, NC
Posted 4 days ago
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.
Client seeking a Clinical Data Manager in the San Francisco, CA area. Position is Office-based!
• Outstanding ability to collect, maintain, validate and manage clinical data
• Manages data management timelines to coordinate and synchronize deliverables with the overall study timelines
• Adept at Electronic Data Capture (EDC) system management
• Strong understanding of regulatory procedures and guidelines
• Extensive experience with Protocol review; SOPs, DOPs, Training Guidelines, Data Management
• Highly skilled in Electronic Data Capture (EDC) data management, including review of the design and development of electronic Case Report Forms (eCRFs), discrepancy management, and validation rules creation
• Demonstrated ability to lead data management activities from study start-up to database lock for both, paper based and EDC environment
• Contributor to annual reports and Clinical Study Reports (CSR) from clinical data perspective
• Generates and/or reviews/approves study documents (e.g. Data Management Plans, Case Report Forms, data transfer specifications, SAE and/or external data reconciliation plans, coding conventions, study protocols)
• Executes and/or distributes data management metrics, listings, and reports, as required
• Oversight of data management CRO/service providers on assigned studies
• Monitors the progress of all data management activities on assigned studies to ensure project timelines are met
• Provides training on the CRF completion guidelines and EDC system at Investigator meetings and to internal or external team members, as needed
• Proactively identifies potential study issues/risks and recommends/implements solutions
• Responsible for the accuracy and completeness of the clinical data collected during a clinical trial, able to work independently towards the assigned goal
• Provide DM support to Statisticians and Statistical Programmers in production of clinical trial reports and other deliverables Requirements
Knowledge, Skills and Abilities:
• Requires solid knowledge of clinical data management principles, clinical trials process and regulatory requirements
• Excellent verbal/written and interpersonal skills required for working successfully in a cross-functional team environment • Able to communicate and collaborate effectively with cross-functional teams in face-to-face conversation, by telephone, and by email
• Good working knowledge of ICH, FDA, and GCP regulations and guidelines
• Strong well-rounded technical skills (EDC systems, MS Word, Excel, PowerPoint)
• Knowledge of industry standards (CDISC, SDTM, CDASH)
• Experience with web-based Electronic Data Capture (EDC), clinical data management systems and industry wide thesauri, such as MedDRA and WHO Drug.
• Proven ability to work both independently or in a team setting Education/ Training
• Bachelor degree in Life Sciences, Computer Sciences, Mathematics, or health related field
• 6+ years of CDM experience in the pharmaceutical or biotechnology industry
• Operating Systems: Windows 98, Windows XP, Windows 2000, UNIX.
• Programming Languages: C, PL/SQL, and MYSQL.
• Statistical Packages: SAS, R
• Database: MS ACCESS, OpenClinica
• Tools: MS-Word, Excel, Power point, and Publisher.
• Mission driven, collaborative
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™
IQVIA is an EEO Employer - Minorities/Females/Protected Veterans/Disabled
IQVIA, Inc. provides reasonable accommodations for applicants with disabilities. Applicants who require reasonable accommodation to submit an application for employment or otherwise participate in the application process should contact IQVIA’s Talent Acquisition team at [Click Here to Email Your Resumé] to arrange for such an accommodation.
Job ID: R1066233