Summarized Purpose:Acts as a senior data management specialist for one or more local laboratory data projects. Leads all data management activities associated with local labs for individual studies and serves as a cross-functional liaison. May support more complex projects.Essential Functions and Other Job Information:Collaborates on the design and user acceptance testing of local lab eCRFs and ensures proper set up of specific lab tool.Ensures data entry and review are performed and consistent with requirements defined by procedure and Data Validation Manual.Reviews lab related documentation and listing review tools for compliance with study protocol and lab standards.Liaises with colleagues in other functional groups, and provides support to senior team members by providing training to clinical staff on local lab procedures, attending project and client team meetings when required, and working with medical monitors to ensure robust review of local lab and related data.Provides training and work direction to junior team members.Ensures study specific lab normal range mailbox is effectively managed by junior level staff.Reviews all lab documentation within Data Validation Manual, Electronic Edit Checks, and eCRF Completion Guidelines.Education and Experience:Bachelor's degree or equivalent and relevant formal academic / vocational qualificationPrevious experience that provides the knowledge, skills, and abilities to perform the job.Knowledge, Skills and Abilities:Solid understanding of challenges of local lab data used in clinical trials to include -collection of local lab ranges, relationship between local lab results and units, relationship between local lab results, ranges and potential adverse events, relationship between local lab data and CTCAE or other grading tools.Good organizational skills with the ability to adapt and adjust to changing priorities and to manage multiple assignments with challenging/conflicting deadlines.Favorable interpersonal skills with an internal and external customer focus Capable of mentoring junior level staff.Proven flexibility and adaptability when working in a team and independently using good judgment in making decisions.Good computer skills and knowledge of databases and how to effectively extract and interpret data.Strong written and verbal communication skills.Ability to maintain a high degree of confidentiality with clinical data and client's proprietary data.Demonstrated ability to analyze processes and contribute to process improvement initiatives.Familiarity with the broader clinical trial process.#J-18808-Ljbffr
