Senior Clinical Data Manager (Remote - US)

Roles and Responsibilities: Confidently displays excellent internal and external customer service. Has proficiency and knowledge of multiple EDC systems; applies this knowledge to advise customers regarding the best-fit EDC solution. Interacts directly and independently with DM suppliers including EDC and/ or IWR; expert communicator, where necessary negotiating with supplier to meet business needs. Interacts directly and independently with client to coordinate all facets of projects; expert communicator; builds and maintains strong client contacts and relationships. Responsible for entire data management process from study set-up to study close-out; primary contact on all data management study-specific issues; has high-level knowledge of drug development as it pertains to data management. Actively participates in protocol review with clients, providing suggestions regarding ability to capture protocol information in database successfully. Strong understanding of GCP/ ICH guidelines and FDA regulations, as applicable to data management. Creates training exercises; serves as mentor and trains new clinical data managers. Provides oversight and resolves all issues in data management study processing activities including CRF tracking and data entry, integration of external electronic data (e.g., lab data) with clinical database, data validation and review, query processing and resolution, adverse event and medication coding, SAE reconciliation, database lock and database QC audits. Oversees and develops data management study documentation including Case Report Forms, CRF Completion Guidelines, Database Design via annotated CRFs, Validation specifications (edit checks), and Data Management Plan. Preparation of any study tracking and metric reports for use by the study team. Oversees execution of user acceptance testing (UAT) of study-specific systems and applications. Interacts with cross-functional team members to ensure completion of all timelines and studies. Participates in data management and/or organizational initiatives. Initiates SOP updates and provide specifications for DM systems/ tools and process enhancements. May act as resource for QC activities in collaboration with QC Coordinator. Understands and follows processes related to project management as appropriate for data management projects (e.g., updating PSS, close-out procedures, etc.).Confident, positive attitude displayed towards clients and projects. Willingness to learn new skills and expand knowledge of drug development. Leads data management projects with little management oversight. Ability to work independently and resolve issues. Ability to clearly articulate the DM services offered at company, including pros and cons of various DM approaches (specific to a client or operating model). To include potential attendance at (web or remote) capabilities and bid defense meetings.

Requirements: Bachelor’s or Master’s Degree in scientific or health care field preferred with industry or relevant experience.5+ years’ experience in data management field with a minimum of 1 year of experience leading projects. Extensive knowledge of paper CRF study systems, EDC, and hybrid CDM systems. Extensive knowledge of Clinical Operations SOPs and Working Practices. Excellent verbal and written communication skills, as well as, interpersonal and organizational skills. Powered by JazzHRWfh0iZI0OP