Sr. Clinical Data Associate
The Senior/Principal Clinical Data Associate (CDA) is responsible for independently performing data management tasks and providing oversight and leadership to support the development, design, implementation, and validation of in-house and outsourced clinical trials for all clinical studies/programs.
ESSENTIAL DUTIES AND RESPONSIBILITIES (include, but are not limited to)
Oversee the development and quality control (QC) of data management documents including data management plans, data validation specifications, data management central files, and database quality control.
Represent Data Management as the Lead CDA on Clinical Project Teams.
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.
Coordinate and assist with any in-house database design, validation, testing, and edit check programming to ensure that the clinical study database meets protocol and data specifications.
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 cleaning 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.
Follows coding guidelines and utilize all available resources to accurately code, with minimal guidance, Medical History, Adverse Event, and Concomitant Medication data using MedDRA and WHO Drug dictionaries.
Provide data management guidance to the Biostatistics and Clinical Operations departments.
Create and provide input in the development of SOPs, Work Instructions, guidelines, standardization of case report forms and edit checks, and selection and implementation of data management software.
Develop and present at Investigator Meetings and train internal and external users (e.g., sites, CRAs) on the use of EDC.
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.
- Comprehensive knowledge of data management practices from protocol design to database lock. Proficiency with Medidata Rave; basic knowledge of SQL.
- Experience working under Good Clinical Practices, Good Clinical Data Management Practices, CDISC/CDASH, and other FDA guidelines is required.
- Proficiency with medical terminology and experience coding clinical data using WHO Drug and MedDRA coding dictionaries.
- 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.
EDUCATION and/or EXPERIENCE
Bachelor’s degree in a scientific discipline with a minimum of 8 years of experience in an in-house bio-pharmaceutical clinical data management position is required.
Additional experience utilizing Rave Architect, FrameMaker, and working at or with a CRO is a plus.