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Clinical Data Manager (lead position) US or Canada fully remote Location USA Type Permanent Sector Biometrics Clinical Data Manager The Clinical Data Manager is responsible for managing all aspects of Clinical Data Management (CDM) process from study start-up, inclusive of database design, through database lock and regulatory submission support for assigned projects. S/he is responsible for assisting with the creation of CRFs, actively involved in User Acceptance Testing (UAT), data cleaning, query generation and management, and assisting in the review of relevant CDM documents. The Clinical Data Manager is responsible for delivering high quality data and documentation and main point of contact for the sponsor/client. More about the company… They are a Global CRO with 30 years in the industry who have been a recipient of multiple awards including 5 CRO Leadership Awards, Forbes best mid-size companies to work for, and ranked top 10 companies by LinkedIn in 2021. Due to their continued business growth, they need to add exceptional talent to support working with their clients who are developing innovative drugs, biologics, medical devices and diagnostics. JOB TITLE Clinical Data Manager (lead position) LOCATION 100% remote. US or Canada based SALARY $90, 000 - $110, 000 benefits package ROLE/DESCRIPTION Assist in all the study specific CDM tasks, including data reconciliation, review of data transfers, Assist in developing and review of CDM study documentation, including Data Management Plans, Data Transfer Specifications Data Validation Specifications and eCRF Completion Guidelines Review clinical study documentation including protocol, project timelines, meeting minutes, memos and study notes to file Generate and analyze CDM metrics and inform cross-functional study teams Participate in User Acceptance Testing for clinical study databases Ensure that delegated and outsourced tasks are performed according to quality standards Ensure that CDM documentation is filed according to SOPs and Work Instructions; review CDM files for completeness and accuracy Facilitate cross-functional data review for assigned studies REQUIREMENTS At least 4 years experience as a clinical data manager 1 years of experience independently leading studies Prior experience working at a CRO or ARO Master's or Bachelor's degree in an applied Science or Life Science discipline required ABOUT i-PHARM CONSULTING i-Pharm Consulting is a specialist Recruitment Company servicing the Pharmaceutical industry in the USA, Europe and Asia Pac. We provide both permanent and contract staff to a wide range of Pharmaceutical, Medical Device, Biotechnology and Contract Research Organizations (CROs). i-Pharm has specific expertise in Clinical Research, Medical Affairs, Regulatory Affairs, Pharmacovigilance, Quality Assurance and Bioinformatics. www.i-pharmconsulting.com TO APPLY If you would like to discuss this vacancy further, please call Practice Lead Caroline Herrera on 1 (646) 462-4092, or email cherrerai-pharmconsulting.com. If this role is not suitable, Caroline is also available to discuss other possible positions or answer any general questions regarding your career and the current market.
Clinical Data Manager (lead position) US or Canada fully remote
Puesto de trabajo: Clinical Data Manager (lead position) US or Canada fully remote