Sr Clinical Data Mgr

Date Posted: 9/9/2024

Senior Clinical Data Manager
Boston, MA (Remote)

Senior Clinical Data Manager will lead all data management activities for sponsored studies throughout the clinical study lifecycle including start-up, maintenance, and completion activities. The primary objective of this position is to ensure clinical study data are collected, handled, and validated in an appropriate and consistent manner to ensure a high-quality database is delivered for statistical analysis within agreed upon project timelines. In addition, the Sr. CDM will be looked upon to standardize process and implement best practices to improve quality and streamline data collection/validation efforts. Will perform and or oversee the following activities: development of electronic Case Report Forms (eCRFs), development of database specifications, development of Data Management Plan (DMP) including electronic edit checks and Data Handling Guidelines, development of Coding Guidelines, development of Core Lab and external data specifications, conduct data review, query generation and resolution, and data reconciliation The Sr. CDM will work on insourced studies as well as engage and work closely with CROs and Vendors that execute the data management and Core Lab services.

Responsibilities:
Lead all data management activities for assigned clinical studies, insourced and/or outsourced. Oversee and manage DM related activities (which may be outsourced to DM Vendors) as well as other external data sources from study start-up to study close-out and final database lock/transfer while ensuring that all study deliverables and milestones are met on time, within budget, and aligned with quality standards. Provide input into study protocols to ensure the data collection requirements are clear and supportive of the study endpoints. Drive the development of high quality eCRFs in consultation with a cross functional team that accurately reflect the data collection requirements defined in the study protocol and that are consistent with internal standards. Oversee database design activities to ensure it meets requirements for the entry and reporting of clinical data. Develop/Review Data Management Plan (DMP) and associated appendices to ensure data quality and integrity. Develop/Review eCRF Completion Guidelines (eCCG) to serve as an aid for site personnel to record data in the Electronic Data Capture (EDC) interface. Perform User Acceptance Testing (UAT) of the database design including eCRF contents, database configuration (edit checks, derivations, dynamics, structure, blinding and permissions) to ensure the quality and integrity of the clinical study database. Conduct/Oversee data review and associated query generation and resolution. Represent Data Management and actively participate on Clinical Study Core Team meetings for all study activities. Identify and implement solutions to project data management issues and concerns, including proactive prevention strategies based on metrics and forecasts including risk mitigation strategies. Develops specification and collaborates with programming for programming and QC of manual listings, external data reconciliation, metrics and custom reports as needed throughout the study. Regularly reviews and queries clinical trial data as indicated in the Data Review Guidelines, Data Validation Specifications and Data Management Plan. Review study data for completeness and clinical feasibility. Assess the overall quality of data and identify key data issues, trends or patterns that may pose overall study compliance and/or data quality concerns, e.g., increased frequency of queries, protocol deviations, and early treatment discontinuations. Train CRAs and/or site personnel in eCCG and clinical systems. Able to use clear judgment to solve problems and to escalate issues with proposed solutions, as necessary. Lead/Author the creation and review of departmental SOPs, Work Instructions, and training materials. Identifies opportunities for standardization and takes initiative to help improvement departmental efficiency. Identify trends in data completion and work with CRAs and/or site personnel to help improve the quality of the data collected. Demonstrates project management skills and balances the triple constraints of time, cost, and quality. Demonstrates an understanding of data structures, database design constraints and needs of SAS Programmers/Statisticians. Patients First | Innovation | Winning Culture | Heart Recovery. Defines and reviews CRO/Vendor scope of work and provides input into study contracts. Constructively challenges process and assumptions to cultivate development and implementation of refined solutions. Provides feedback on process, execution, and performance to foster continuous learning and growth of self and team. Provides mentoring/coaching of new hires and/or junior associates. Maintains accurate and complete study records. Ability to perform additional responsibilities as requested.

Requirements:
Bachelor’s degree from an accredited university ; BS preferred in Life Sciences, Nursing, Computer Sciences, Data Science/Analytics, Mathematics, or related medical/scientific field1. Minimum of six years data management experience in CRO, pharmaceutical, biotechnology, or medical device industry1. Prior knowledge and experience with Medidata RAVE required. Experience with other Medidata platform applications including TSDV, Imaging (MMI), RTSM, TSDV, and CTMS desired. Experience with Veeva Vault electronic Trial Master File (eTMF) desired. Experience with JReview and Business Objects desired. CRO/vendor management experience desired. Knowledge of GCP and FDA Code of Federal Regulations required. Knowledge of International Regulations desired. Must be computer savvy and highly proficient in Microsoft Office. High attention to details and accuracy; ability to work independently and to prioritize and organize work to meet deadlines. Excellent communication, written and interpersonal skills; Works effectively on cross-functional teams. Self-sufficient and able to prioritize and work on multiple tasks & studies with minimal oversight. Able to develop project management objectives, as needed.

Please contact Darren Gutowski at dgutowski@clarkdavis.com