We are seeking a dedicated and detail-oriented eCOA Vendor Startup Manager (eCOA / Study Start-Up) to join our team.

　　This remote role is open to candidates across the US specializing in Clinical Trial Study Startup , eCOA, and Vendor Management .

　　Key Responsibilities

　　eCOA: Partner with Sponsor and vendors on eCOA system implementation

　　Study Start-Up Process Optimization : Optimize a frontloaded and timely study start-up process in support of a timely vendor database go-live.

　　Vendor Protocol Review : Review vendor and category-related sections of the protocol, ensuring vendor expertise is leveraged when refining specifications towards the Final Protocol.

　　Study Specification Worksheet (SSW) Development : Contribute to the development of the SSW to facilitate the bid process and selection of vendors.

　　Quote/Proposal Review : Collaborate with procurement and vendors for quote/proposal review. Support contract negotiations, if required.

　　Vendor Budget Review : Conduct a thorough review of final vendor quotes.

　　Vendor Meeting Coordination : Coordinate vendor kick-off meetings and other vendor-specific meetings.

　　Document Collection : Collect Health Authority (HA) submission documents from vendors, as requested by participating countries in a study.

　　Protocol Changes Management : Ensure changes to protocol or study designs are consistently shared with vendors and incorporated into supplier budgets, timelines, and specifications. Support the amendment of vendor contracts with the Procurement team.

　　Study Start-Up Process Optimization : Optimize a frontloaded and timely study start-up process in support of a timely vendor database go-live.

　　Vendor Service Excellence : Ensure vendors meet quality and service level standards in their service delivery for the trial.

　　Risk Management : Proactively create and maintain vendor-related risk maps with contingency plans for documentation in FIRST.

　　Issue Resolution : Document issues identified with vendor oversight/performance in the FIRST tool and implement and monitor corrective actions. Escalate issues, if required, to the Vendor Category Expert (VCE).

　　Qualifications

　　Bachelor's Degree Bachelor's Degree in health care or other scientific discipline

　　5 years clinical research/monitoring experience or equivalent combination of education, training and experience

　　Requires basic knowledge of Project management practices and terminology.

　　Good knowledge of applicable clinical research regulatory requirements i.e., Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines

　　Requires broad protocol knowledge and therapeutic knowledge.; Req

　　Requires good understanding of Clinical Research industry (drug/device/technology/etc.) and the relevant environments in which it operates

　　Understanding of project finances

　　Knowledge of clinical trials - Knowledge of clinical trial conduct in addition to skill in applying applicable clinical research regulatory requirements i.e. International Conference on Harmonization (ICH) and Good Clinical Practice (GCP) and relevant local laws, regulations and guidelines, towards clinical trial conduct.

　　Communication - Strong written and verbal communication skills including good command of English language.

　　IQVIA is a leading global provider of advanced analytics, technology solutions and clinical research services to the life sciences industry. 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. Learn more at https://jobs.iqvia.com

　　We are committed to providing equal employment opportunities for all, including veterans and candidates with disabilities. https://jobs.iqvia.com/eoe

　　IQVIA’s ability to operate and provide certain services to customers and partners necessitates IQVIA and its employees meet specific requirements regarding COVID-19 vaccination status. https://jobs.iqvia.com/covid-19-vaccine-status

　　The potential base pay range for this role, when annualized, is $87,900.00 - $175,800.00. The actual base pay offered may vary based on a number of factors including job-related qualifications such as knowledge, skills, education, and experience; location; and/or schedule (full or part-time). Dependent on the position offered, incentive plans, bonuses, and/or other forms of compensation may be offered, in addition to a range of health and welfare and/or other benefits.

　　IQVIA is a world leader in using data, technology, advanced analytics, and expertise to help customers drive healthcare – and human health – forward. Together with the companies we serve, we are enabling a more modern, more effective and more efficient healthcare system, and creating breakthrough solutions that transform business and patient outcomes.

　　To get there, it takes diverse skills and a curiosity to explore new possibilities. No matter your role, everyone at IQVIA, including our colleagues at Q² Solutions, contributes to our shared goal of improving human health. Thank you for your interest in growing your career with us.

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