Lead Clinical Data Manager

Volt - Massachusetts - A clinical-stage bio-technology company are looking to hire a Lead Clinical Data Manager to be responsible for all clinical data management activities for studies assigned. Role Work with SAS and/or clinical systems programming to produce in-process data reports and data visualization tools to facilitate decision making on clinical trials (e.g., safety reviews). This role participates in cross functional team communications and meetings with both internal and external collaborators and oversees the data management activities at contract research organizations (CRO). The Lead Clinical Data Manager will also participate in the development of department documents and procedures and mentor more junior data management staff. Functions as internal Data Management Study lead, overseeing all data management activities performed by CROs including generation and review of metric status and patient tracking reports. Works to ensure on-time achievement of major data management deliverables and milestones in coordination with other functions Reviews and provides input into protocols and other clinical study documents during development Reviews and manages key documents such as data management plan, guidelines for CRF completion, data review, SAE reconciliation, and data audits. Provide DM-level review and input on study medical coding Following CDISC conventions, oversee or perform eCRF design and annotation, database design specifications; Develop or oversee CRO generation of data edit check specifications; Participate in user acceptance testing (UAT) of the clinical database, including edit check testing Provide input on Company specifications for internal study team data review plan and guidelines and Protocol Deviation specifications document Participates in study team data review; Perform data review for quality issues and general data trends; generate queries as necessary Defines/oversees data transfer specifications for external data sources (labs, ECGs, PK) and transfer of data; reconcile or oversee CRO lab reconciliation with clinical database Provide input on standard tools and reports Requirements Represent Company Data Management function at study level, and with internal colleagues. Bachelor's degree in scientific/technical discipline is required 5+ years of relevant work experience with a focus on data management Knowledge of clinical data management outsourcing with full-service global CROs and niche service providers Experience in clinical oncology indications, end points, data flow, data integrity, standards and data quality Apply now... - Permanent - Full-time

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