Clinical Data Manager Jobs

Southborough, MA

Job Description:

Under general supervision, the Clinical Data Manager reviews data; assists in database design and testing; designs CRFs and guidelines; designs and tests logic checks; generates queries for missing or discrepant data; utilizes tools/systems to code medical terms and medications; works with Clinical Monitoring, Medical Affairs, Database Development, Biometrics and Project Management personnel to resolve project related issues; provides input into the Dept. SOPâ??s and process improvements, and may participate in working groups, and the training of other CDMâ??s.

ESSENTIAL DUTIES AND RESPONSIBILITIES INCLUDE THE FOLLOWING:
- Review and understand protocol.
- Relate CRF design to protocol and ensure consistency. Identify and suggest design for standard data types.
- Create effective / efficient CRF design for standard data types.
- Create CRF completion guidelines.
- 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. 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.
- Monitor Clinical Data Management project status through use of standardized status reports and customized metrics.
- Assist Sr. CDM with external data providers import/ exports of data.
- Develop, define, test and validate logic checks. Apply standard logic checks to routine data cleaning.
- 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.
- Utilize available tools, systems and processes in coding medical terms and medications.
- Reconcile clinical AEs with SAEs according to established guidelines.
- Understand the fundamentals in managing lab data, including normal ranges and units from local and central labs.
- Understand the fundamentals of merging external data with the clinical CRF 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 final data tables, listings, and report.
- Assisting with Data Management Initiatives.
- Work under the direction and guidance of an Associate Manager or a Manager and Senior CDM or Principal CDM in the following areas:
- Suggest and/or challenge unnecessary data collection and identify gaps in detail content
- CRF design for complex data types
- Identify data that will require non-standard programming. Identify errors in design and recommend what corrective action is necessary.
- Create new tools for tracking and inventory, including reports to identify discrepancies.
- Identify inefficiencies in entry flow and recommend solutions or improvements.
- Identify complex checks that are non-standard and contribute to logic check definition with understanding of analysis plan content.
- Develop database specifications to facilitate the collecting, processing and reporting for lab data.
- Represent department at industry and client meetings.

- Perform all other duties as assigned.

EDUCATION AND/OR EXPERIENCE:
- Bachelorâ??s degree and 1 year of clinical data management experience in a role with equivalence to CDM/CDC, or minimum 4 years clinical data management experience in a role with equivalence to CDM/CDC.
- Preferred Qualifications:
Bachelorâ??s and 1+ years of clinical data management experience or 4 + years of clinical data management experience in a CRO/pharmaceutical/biotech environment.

ESSENTIAL KNOWLEDGE, SKILLS & LICENSES:
- Must have a basic understanding of the clinical research development process and database design; a good understanding of the clinical data management process, physiology, pharmacology, and clinical study objectives and methodologies
- Must have good problem-solving skills and be detail-oriented
- Excellent organizational skills with ability to work in a high volume and strict deadline environment
- Proficiency in operating computer applications and navigating the internet
- Excellent interpersonal skills
- Excellent verbal and written communications skills
- Ability to work independently

For more informaton please call 508-597-6000