Clinical Data Specialist II

Description: Posting Title: Clinical Data Specialist II Location: Cambridge, MA Department: Clinical Data Management Classification: Biotech/Pharmaceutical Required Travel: Minimal Required Education: B.S/M.S. Relocation: Yes Job Description Vertex Pharmaceuticals Incorporated is a global biotechnology company committed to the discovery and development of breakthrough small molecule drugs for serious diseases. The Company's strategy is to commercialize its products both independently and in collaboration with major pharmaceutical companies. Vertex's product pipeline is focused on viral diseases, inflammation, autoimmune diseases, cancer, pain and bacterial infection. Position Overview: The Clinical Data Specialist II is an individual contributor performing complex data management tasks independently. The Clinical Data Specialist II plays a key role on moderately complex studies. In addition, the Clinical Data Specialist II manages external vendors on assigned studies. Key Responsibilities: Reviews clinical study protocols and provides input Develops eCRFs for new and complex projects Develops study – specific procedures, metrics, listing specifications and Electronic Data handling processes Conducts cross-functional Formatted Data Review Develops and maintains Data Management study timeline Oversees vendor DM activities, including timeliness and quality of deliverables Reviews statistical tables and listings and Clinical Study Reports Ensures study compliance with SOPs and regulations and develops study-specific training for internal and external study team Plans and oversees development of Data Management Plans, Data Entry Guidelines, CRF Completion Guidelines, Data Review Guidelines, and eCRF help text Plans, performs, and oversees development of specifications for eCRFs, Edit Checks, electronic data handling, and manual review Plans and oversees execution of User Acceptance Testing Prepares and delivers presentations at internal and external meetings May oversee activities of a CDM team on a study May define and manage CDM project timelines on a study, evaluate and mitigates risks May be responsible for all aspects of the CDM study deliverables on a smaller-scope studies May review vendor RFIs, RFPs, proposals and contracts and provide input Provides input regarding project resource requirements and timelines May supervise other Clinical Data Management staff Requirements Subject matter expert in EDC related tools and processes Demonstrates well developed instincts and problem-solving skills in all areas of data management Understands cross-functional team roles within Clinical Development Able to provide some leadership on a cross-functional team and work effectively in a matrix environment Apply Now