Sr. Clinical Database Specialist
The Senior Clinical Database Specialist is responsible for independently performing data management tasks, including clinical study database design and build, as well as providing oversight and leadership to support both in-house and outsourced clinical trials.
PRIMARY DUTIES & RESPONSIBILITIES:
- Oversee the development and quality control (QC) of data management documents including data management plans, data validation specifications, data transfer agreements, and database quality control.
- Represent Data Management as the clinical study database expert on Clinical Project Teams.
- Design/program eCRFs, edit checks, and derivations in the EDC database (following protocol requirements and company standards); perform and document user acceptance testing on databases; perform database migrations.
- Ensure that appropriate data validation (edit check) specifications, quality control checks, and any manual review procedures (eg, listing review) are implemented according to standard operating procedures (SOPs).
- Develop Clinical Data Management timelines (with management approval) including interim and final database lock and data reviews; monitor overall data management tasks to ensure that timelines are met and that any issues are proactively identified and resolved.
- Identify, create, and utilize appropriate reports to ensure data validation and overall project timelines are met.
- Identify, analyze, propose solutions, and effectively resolve complex data issues by exercising appropriate judgment and collaborating with the clinical project team members.
- Coordinate and ensure completion of all aspects of data review, including running validation procedures, issuing queries, database QC, SAE Reconciliation, medical coding, and database closure activities according to SOPs.
- Serves as a data management expert and works with Biostatistics and Clinical Operations departments to ensure data is CDISC/SDTM compliant.
- Create and provide input in the development of SOPs, guidelines, standardization of case report forms and edit checks, and selection and implementation/validation of data management software.
- Recommend improvements to existing Clinical Data Management practices and procedures (SOPs, Work Instructions), including identifying and recommending solutions for technology issues.
- Perform other duties as assigned.
- Bachelor’s degree in computer sciences or a scientific discipline with a minimum of 6 years of experience in an in-house bio-pharmaceutical clinical data management position is required;
- Additional experience working at or managing vendors/CROs is a plus.
- Comprehensive knowledge of data management practices from protocol design to database development;
- Proficiency with Medidata Rave (including Architect, Amendment Manager, and Targeted SDV);
- intermediate knowledge of Business Objects and SQL;
- general understanding of SAS;
- Experience working under Good Clinical Practices, Good Clinical Data Management Practices, CDISC/CDASH/SDTM, and other FDA guidelines is required;
- Demonstrated solid oral and written communication skills and analytical/problem-solving skills are essential as is the ability to clearly communicate basic data management concepts to those outside data management;
- Must be able to effectively manage multiple projects and timelines;
- Must be able to travel up to 5% per year;
- Requires the ability to sit or stand while working on a computer for a long period of time.