.*position title*: senior clinical data specialist*reports to*: associate manager/manager, data management or designee*basic functions*:*essential job functions, duties and responsibilities*:- clinical data and query review:- create listings using ad hoc query tools- issue queries and review query responses with the highest level of quality based upon the data review plan, manual review (tumor response, ae/cm compares), and reconciliation (laboratory, sae, ecg, and other vendors)- assist other data reviews for biostatistics, medical review, client, and other ad hoc reports- oversees system development:- create or draft crf design, edit check specification and dm listings- consolidate comments from internal/sponsor for discussion and approval- ensure all non-dm activities related to database development are completed in a timely manner- subject matter expert for dm product or process:- create and update sops/wp related to the product or process- provide training for dm and other staff members on process and/or product implementation- consult with dm leads or other team members on implementation and best practices- participate in user group meetings as the iqvia biotech representative- study management:- may serve as lead dm or back-up dm lead- produce and review metric reports for internal/external project team- provide feedback to improve the system or reports- discuss roadblocks for getting processes done in a timely manner- review project budgets and staffing projections for data management activities- provide the dm lead or pm with status updates on tasks that are assigned- assist with the on the job training of dm staff for the study*knowledge, skills and abilities*:- team player with ability to work well with technical and clinical team members- ability to collaborate with entire clinical team (cras, safety, bios, etc.)- excellent knowledge of clinical data concepts including knowledge of unique data collection concepts (recist, cdisc/cdash, labs, adjudication, etc.)- ability to adhere to and create detailed dm study instructions and documents (crf guidelines, trial design document, edit check specifications, etc.)- ability to perform research for data collection and protocol specific topics- proficiency with multiple dbms processing systems (preferred systems are inform and rave)- organized and thorough with attention to details- effective interpersonal skills and excellent communications skills, verbal, written and listening- ability to learn new things, teach others, and accept constructive criticism- effective logical thinking ability regarding problem-solving skills- ability to work independently*critical job functions in accordance with ada criteria*:- very little physical effort required to perform normal job duties (unless otherwise indicated)- travel, occasional as required for bid defenses, investigator meetings, or other meetings as requested, not anticipated to exceed 40hr per year