Job Description

This range is provided by Bayside Solutions. Your actual pay will be based on your skills and experience — talk with your recruiter to learn more. Base pay range $75.00/hr - $85.00/hr Senior Clinical Data Manager W2 Contract Salary Range: $156,000 - $176,800 per year Job Summary: As a Senior Clinical Data Manager, you will develop strategy, lead data management activities, and interface with the project team to ensure that data management services are delivered in a consistent, high-quality manner. You will independently perform and oversee database-related tasks, report setup and processing, and cleaning clinical trial data, following all applicable standard and study-specific procedures. Duties and Responsibilities: Serve as a data management expert and, if assigned, be the CDM lead for assigned clinical studies on multi-disciplinary project teams. Deliver high-quality data for analysis and study milestones. Review protocols from a CDM perspective and provide functional-expert feedback. Review and approve key clinical data management deliverables generated by a DM vendor, including Case Report Form (CRF) design, CRF completion guidelines, database design specifications, data entry guidelines, data management plans, edit check specifications, serious adverse event reconciliation plans, medical coding, data listing specifications, and electronic data transfer agreements. Manage and oversee study setup, testing, and system validation for new studies in partnership with the DM vendor. Perform and oversee data cleaning activities executed by the DM vendor and ensure protocol-specified guidelines are applied to the review and cleaning of clinical data. Collaborate with internal Data Science (statistical programming), Biostatistics, and Medical Monitor to identify critical clinical dataset variables for protocol-specified endpoints. Coordinate the implementation of these variables into DM vendor activities. Develop and manage timelines for key clinical data management deliverables in coordination with the clinical data management vendor and project team. Monitor vendor performance to ensure timelines and data quality standards are met. Ensure compliance of clinical data management processes with applicable regulations and guidelines. Requirements and Qualifications: BA/BS or higher, preferably in math, science, or a health-related field, with a minimum of 5+ years of experience in clinical data management across phase 1- 3 clinical trials. 5+ years of experience acting as a study lead data manager. Experience in all study phases, including early-phase; dose escalation study experience is greatly preferred. CNS/Neurodegenerative trial experience is highly preferred. Comprehensive experience working with clinical database systems. Working knowledge of CDISC, including CDASH, TAUG, and SDTM, as well as data privacy regulations (GDPR). Able to work in a fast-paced and dynamic environment while effectively managing multiple projects that may have changing priorities. Able to work collaboratively on multi-disciplinary project teams and develop productive relationships with external vendors. Clear verbal and written communication skills. Strong analytical and problem-solving skills. Desired Skills and Experience: Clinical data management, clinical trial, clinical database, CRF, data cleaning, CDISC, CDASH, TAUG, SDTM, GDPR. Bayside Solutions, Inc. is not able to sponsor any candidates at this time. Additionally, candidates for this position must qualify as a W2 candidate. Bayside Solutions, Inc. may collect your personal information during the position application process. Please reference Bayside Solutions, Inc.'s CCPA Privacy Policy at Seniority level Mid-Senior level Employment type Contract Job function Information Technology and Science #J-18808-Ljbffr Bayside Solutions

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