eTMF Coordinator (Raleigh, NC)

| Raleigh-Durham, NC
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Job description

Job Family Description

Provides operational support to the Clinical Research organization to ensure the wellbeing of clinical research subjects and the best possible project outcomes.

Sub-Family Description

Manages records and coordinates with project teams regarding information and records issues. Serves as the primary client contact for records/retrieval issues; coordinates and delivers on the retrieval of records requested by users and prepares closed studies for transfer to final destinations; monitors records filing accuracy and compliance to QI and/or client file plans/SOPs; and recommends changes or revisions to records retention schedules.

Job Profile Summary:

Serve as the liaison between Records Management and user departments regarding Trial Master Files. Apply Records Management expertise to provide project related assistance across multiple project(s), sites, and project teams. May be required to ensure that project timelines are met and facilitate the orderly scanning, transfer, retention, and disposition of various project-related and business records. Ensure all work is conducted in accordance with Standard Operating Procedures (SOPs), policies, practices, good clinical practices, applicable regulatory requirements, and meets quality and timeline metrics. May lead teams functionally, where assigned, including awareness of scope of work, budget, and resources. May manage a team of records management or technically-related staff working in support of projects within a designated office, country, or region.

Responsibilities:• Apply Records Management expertise to provide project related assistance across complex, multiple project(s), and project teams• Serve as the liaison between Records Management and user departments regarding Trial Master files• Serve as primary contact for internal/external clients• Ensure project deadlines, commitments, and goals are met by monitoring project's daily outputs• Ensure all work is conducted in accordance with Standard Operating Procedures (SOPs), policies, practices, good clinical practices, applicable regulatory requirements, and meets quality and timeline metrics• Maintain records center security to protect record integrity by ensuring compliance to SOPs• Collect data and assist in the preparation of statistical reports for management of record center operations, as appropriate or as requested• Coordinate the retrieval of records requested by users and prepare closed studies for transfer to final destination within the agreed timelines• Train team members on records management tasks, policies, and procedures• May assist management with the implementation of plans, cost proposals, and resource projections for records management projects• May lead teams functionally, where assigned, including awareness of scope of work, budget, and resources• May Maintain accurate trackers and systems to control records and box inventory• May coordinate transfer, recall, and disposition of records to commercial records storage centers• May oversee disposal of obsolete records and ensure efficient maintenance of records storage space, supplies, and equipment

At IQVIA, we believe in pushing the boundaries of human science and data science to make the biggest impact possible - to help our customers create a healthier world. The advanced analytics, technology solutions and contract research services we provide to the life sciences industry are made possible by our 70,000+ employees around the world who apply their insight, curiosity and intellectual courage every step of the way. Learn more at jobs.iqvia.com .

All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, status as a protected veteran, or any other status protected by applicable law.

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 [email protected] to arrange for such an accommodation.
More Information on IQVIA
IQVIA operates in the Healthtech industry. The company is located in Durham, NC. IQVIA was founded in 2016. It has 61500 total employees. It offers perks and benefits such as Flexible Spending Account (FSA), Disability Insurance, Dental Benefits, Vision Benefits, Health Insurance Benefits and Life Insurance. To see all 369 open jobs at IQVIA, click here.
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