Employment

Senior Clinical Data Manager

Advance Research Associates provides Data Management and Statistical Analysis services to the biotech, pharmaceutical, and medical device industries.

Primary Function of Position: The primary function of this position is to coordinate internal and external project and data management activities and to manage project data management-related activities. Studies may be paper CRF studies or use Electronic Data Capture.

ARA company culture is entrepreneurial. The successful candidate is expected to be self-directed, flexible, with a dedicated work ethic and attention to results and productivity.

Position Description and Responsibilities: The Senior Clinical Data Manager will be responsible for serving as the primary contact for the client, communicating client timelines and deliverables to ARA staff. This individual must be a proactive team player, dedicated to enhancing the quality of services provided to clients. You will have demonstrated leadership ability and be skilled in coordinating data management workflow for assigned projects. The successful candidate will participate as the data management expert on client project teams, providing specific expertise on timeline development and identification of data management deliverables. You will support and influence clinical project teams to effectively manage information flow, data collection, and review and clarification activities according to sponsor and protocol requirements, and in accordance with appropriate regulatory, company, and departmental guidelines. You will document project-specific data management, data validation, and data entry guidelines to ensure appropriate, consistent, and efficient processing of data, as well as document data transfer specifications in collaboration with sponsor organizations. This role supports the documentation, testing, and implementation of clinical databases. This role is responsible for reviewing and validating all data generated from a project, including reconciliation of external data (e.g., central laboratories, local laboratories) to ensure all data is correct, complete, and logical. The Senior Clinical Data Manager coordinates execution of data validation programs, generates queries on potentially discrepant data to obtain clarification, and integrates query responses into the clinical database. You will document database study assumption changes, execute auto/manual coding of clinical data (e.g., adverse events, concomitant medications, diagnoses), using standard or sponsor-defined dictionaries, and reconcile clinical database adverse events with serious adverse event reporting systems according to guidelines. This role is responsible for initiating and maintaining data management project file documentation, tracking and reporting data management activity status (including milestones and timelines), and ensuring project data is of high quality and ready for transfer and/or statistical analysis.

For immediate consideration, please contact:
Michelle Stoddard
Director, Operations
Advance Research Associates
2107 Landings Drive
Mountain View, CA 94043
Phone:(650) 810-1190 x12
Fax:(650) 810-1195
Email: mstoddard@araonline.net
Principals only.