Sr. Clinical Data Manager (Job # 1262)

Position Information
Posted Date	2008-12-04 16:40:22
Type	Direct-Hire
Job Category:	Data Management
Position	Full Time
City	Southborough
Location	Massachusetts, United States of America
Experience	Advanced degree and 3+ years experience in clinical data management; experience leading a team; experience training or mentoring staff, and 1+ years of CRO experience.
Education	Bachelor's Degree
Travel

Description

Job Details: Under general supervision, the Senior CDM reviews data; assists in database design and testing; designs CRFs and guidelines; designs and tests logic checks; generate queries for missing or discrepant data; utilizes tools/systems to code medical terms and medications; interfaces with Clinical Monitoring, Medical Affairs, Database Development, Biometrics and Project Management personnel to resolve project related issues; provides clinical data management expertise to all aspects of the study, provides input into the Dept. SOPs and process improvements, participates in working groups and training of other CDMs. Serves as a resource to other Clinical Data Management staff and/or personnel and clients outside of the department. ESSENTIAL DUTIES AND RESPONSIBILITIES INCLUDE THE FOLLOWING: • Review and understand protocol with reasonable comprehension. • Suggest and/or challenge unnecessary data collection and identify gaps in detail content. • Relate CRF design to protocol and ensure consistency. Identify and suggest design for standard data types. • Create effective/efficient CRF design for standard and complex data types. • Create CRF completion guidelines. • Organize and present CRF and CRF completion guidelines at investigator meetings. • Review and contribute to database design specifications and assure all data fields are captured and validation checks are complete. Assist in database design and build activities. Identify data that will require non-standard programming for database design. Identify errors in design and recommend what corrective action is necessary. Test database prior to release into production. • Development and maintenance of the Data Management Plan (DMP), the Data Cleaning specifications and various other Data Management documentation. • Ensure accurate tracking of all CRFs and DCFs and identify any missing information. • Prepare CRF for data entry, apply data handling guidelines. Notify data entry supervisor of entry and tracking priorities. • Identify inefficiencies in entry flow and work with management to recommend solutions or improvements. • Monitor Clinical Data Management project status through use of standardized status reports and customized metrics. • Work with external data providers on import/ exports of data. • Develop, define, test and validate logic checks. Apply standard logic checks to routine data cleaning. With understanding of analysis plan content, identify complex checks that are non-standard and contribute to logic check definition. • Review logic check output, CRFs, and listings to identify missing or discrepant data. Generate DCFs based on standard data cleaning practices. Write clear and concise queries. • Evaluate and improve efficiency in data cleaning process by identifying tools and processes that will make CRF review more efficient. • Define project standards for written queries and the DCF process. • Create new tools for tracking and inventory, including reports to identify discrepancies. • Utilize available tools, systems and processes in coding medical terms and medications. Review and provide feedback on coded terms. Understand coding algorithms and assure correct algorithms and coding systems are utilized. • Reconcile clinical AEs with SAEs according to established guidelines. • Provide expertise in managing lab data, including normal ranges and units from local and central labs. Develop database specifications to facilitate the collecting, processing and reporting for lab data. • Provide expertise in merging external data with the clinical CRF data. Develop database specifications, collecting, processing and reporting for external data. • Coordinate data entry audits. Creation of Audit Results Report. • Ensure that all steps prior to locking the database are complete, utilizing a CDM checklist. • Review and identify inconsistencies within the analysis plan, the final data tables, listings, and report, including review of SAE narratives. • Provide input for changes to Standard Operating Procedures and process improvements where appropriate. • Provide input into new technologies to aid in clinical data management. • Coordinate or guide CDC and CDM tasks on large projects. • Assisting with Data Management Initiatives. • Represent department at industry and client meetings. • Perform all other duties as assigned.

Qualification

Advanced degree and 3+ years experience in clinical data management; experience leading a team; experience training or mentoring staff, and 1+ years of CRO experience.

Education Detail

Bachelor’s degree and minimum 3 years experience in clinical data management as a CDM including some experience in a CRO/pharmaceutical/biotech environment and experience leading a team or 5 years clinical data management experience as a CDM.

Knowledge

• Must have a thorough understanding of: the clinical research development process; standard operating procedures; good clinical practices; the clinical data management process; physiology, pharmacology, clinical study objectives and methodologies; the definition of serious adverse events and how they apply to review of clinical data. • Must have very good computer skills; good understanding of database design, CRF design techniques. • Must have the ability to lead a large-scale project and/or an initiative effectively providing training, organization and support in conduct of the project/initiative. • Excellent problem-solving skills and be detail-oriented. • Must have excellent organizational skills with ability to work in a high volume and strict deadline environment • Excellent interpersonal skills • Excellent verbal and written communications skills • Ability to work independently