The Senior Clinical Data Associate (Sr. CDA) in Data Management (DM) is an individual and team contributor. Supports DM Leads and the Data Management Department. The core duties and responsibilities of the Sr. CDA are delineated below.
Essential Duties/ Responsibilities Department Level: • Participates in the development, review and implementation of departmental SOPs, templates and processes • May have project oversight of internal clinical data associates • Provide feedback and task assignment • Contributes to technical infrastructure of data management • May participate in department or cross-functional initiatives DM/Study Tasks: • Perform all data management tasks as appropriate including, but not to be limited to: data review and query management to ensure that quality standards are achieved. • Perform reconciliation of the clinical database against safety data, laboratory data and other third party data as appropriate • Review clinical trial data in accordance with Data Management Plans, Edit Check Specifications and/or Data Review Guidelines and raise queries to resolve erroneous, missing, incomplete or implausible data • Generate, resolve and track queries to address problematic data identified during data review activities and apply proper modification/correction to the database as required • Interact with other project team members to support the set-up, maintenance, and closure (e.g., Database Lock) of the Data Management aspects of the project and attend meetings as required • Actively participate in eCRF Screen Review meetings • Create, review, and/or execute Form and Edit Check Specification User Acceptance Testing by creating/reviewing dummy data to evaluate EDC database functionality • Modify standard templates to create study specific Data Management Plans, or eCRF completion guidelines • Assist in preparing Access Rights forms for EDC database • Filing of Data Management documentation and data management related administrative tasks as requested, including maintenance of TMF as requested • Demonstrate awareness of project schedules and the importance of meeting deadlines • Performs any other duties as assigned Requirements • Good oral and written communication skills • Able to communicate work progress and make department level presentations • Demonstrate ability to work in a team environment and collaborate with peers/team • Demonstrate good organizational ability and interpersonal skills • Demonstrate time management skill and ability to adhere to project productivity metrics and timelines • Demonstrate a constructive problem solving attitude while deadline focused with time demands, incomplete information or unexpected events Education/ Training • Bachelor degree in Life Sciences, Computer Sciences, Mathematics or health-related field preferred • 4 years or greater relevant work experience in data management in a biotech, pharmaceutical setting, or CRO or experience as clinical data coordinator at a clinical site; depth and exposure to DM related tasks considered in lieu of minimum requirement • Good understanding of pharmaceutical industry, clinical trial development/drug development and the role of DM • Good working knowledge of ICH, FDA, and GCP regulations and guidelines • Understands Biometrics component of Clinical Affairs • Prior experience with detailed documentation processes