In anticipation of the Company's growth plans, we are seeking to recruit a Senior Clinical Data Manager (CDM) Contractor. The Senior CDM Contractor will work in an outsourced data management model. He or she will develop a 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. This individual will also independently perform/oversee tasks related to database and report setup, as well as processing and cleaning clinical trial data, following all applicable standards 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 multidisciplinary 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/oversee study setup, testing, and system validation for new studies in partnership with the DM vendor.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), internal Biostatistics, and internal Medical Monitor on identifying critical variables in the clinical dataset for protocol-specified endpoints. Coordinate implementing 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 our 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:Typically requires a Bachelor's degree ence, or a health-related field and a minimum of 10 years of clinical data management experience rmaceutical, or health-related industries.Demonstrated proficiency leading CDM deliverables across Phase 1-3 clinical trials, including early-phase and dose-escalation studiesSolid understanding of the clinical drug development process and regulatory/data standards (ICH/FDA, CDISC - CDASH, SDTM, ADaM - GCDMP, 21 CFR Part 11, MedDRA, WHO Drug Dictionaries, GDPR)Demonstrated understanding of the clinical trial database life cycle, including CRF design, development/testing, discrepancy management, data quality review, and database lockCapable of proactively identifying project risks and proposing strategic solutions; excellent multidisciplinary interpersonal and communication skillsStrong analytical and problem-solving skills; able to work independently and within cross-functional project teamsDesired Skills and ExperienceClinical data management, Phase 1-3 clinical trials, early-phase studies, dose-escalation studiesCDM leadership, outsourced data management, vendor oversightClinical database lifecycle, CRF design, CRF completion guidelines, database design specifications, database setup and testing, system validationData management plans, edit check specifications, data entry guidelines, data cleaning, discrepancy management, data quality review, database lockSAE reconciliation, medical coding, data listing specifications, electronic data transfersClinical protocols, clinical drug development, study timelines, vendor performance monitoring, risk managementCross-functional collaboration, statistical programming collaboration, biostatistics collaboration, medical monitoring collaborationClinical endpoints, regulatory compliance, ICH, FDA regulations, CDISC, CDASH, SDTM, ADaM, GCDMP, 21 CFR Part 11, MedDRA, WHO Drug Dictionary, GDPRData analysis readiness, analytical skills, problem-solving, communication, project management, independent workBayside 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 www.baysidesolutions.com.
4 days ago