The Data Manager position is responsible for contributing to the management of data used for C-Path research purposes and supporting the development of clinical/preclinical data standards. This position supports all C-Path consortia that utilize clinical and preclinical data in their projects. Position will utilize vendor and internally developed tools to identify and solve data process flow, data review and data quality problems, and to create data sub-sets required by research plans. Position will also assist with the design and implementation of logical and physical databases.
Title: Data Manager
Department: Data Standards, Management and Technology (DSMT)
Reports to: Chief Technology Officer
Status: Full-time, Exempt
Location: Tucson, AZ
Qualifications: To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
Essential Job Duties and Responsibilities:
- Validate, review and analyze preclinical and clinical data.
- Implement mapping specifications from source data to CDISC data standards.
- Investigate data and create analysis data sets based on research specifications.
- Map, extract, transform and load data into C-Path databases in accordance with CDISC standards.
- Implement improved database quality control tools and processes.
- Perform general database management and administration tasks.
- Utilize vendor and internally developed tools to identify and resolve data quality problems.
- Assist with the implementation and support of logic and physical databases.
- Develop extensions to CDISC standards and terminology to include therapeutic areas not currently covered by CDISC standards.
- Develop and update annotated SDTM compliant CRFs and data files.
- In support of C-Path and CDISC, support terminology development projects relevant to core standards.
- Support effective collaborations with key regulatory agencies, pharmaceutical companies and academic institutions.
- Work effectively with C-Path, CDISC and consortia team members dispersed across U.S. and international regions via teleconference and web meetings.
- Follow-up on outstanding action items with team members to ensure that team milestones and deliverables are met in the appropriate timeframe.
- Other duties and responsibilities may be assigned.
Supervisory Responsibilities: None
Contacts:
- Internal: All C-Path staff and consultants
- External: Representatives of CDISC, consortia team members, scientific/research community, vendors, contractors, and other stakeholders.
Education and Training:
- Bachelor’s degree in Life Science, Data Management, Computer Science, or Medical Technology; Master’s degree preferred.
- 3+ years’ experience in industry (pharmaceutical, CRO, biotechnology)
- Experience monitoring and/or managing clinical trials preferred.
- Experience in use and manipulation of SAS data sets preferred.
Certificates/Licenses: None
Knowledge/Skill/Abilities:
- Excellent interpersonal skills and problem solving/decision making skills.
- Excellent organizational skills.
- Demonstrated negotiation skills.
- Strong programming skills in SAS and/or MSSQL, and any other software necessary.
- Works well independently and in a team-oriented, collaborative environment.
- Knowledge of clinical/preclinical research industry and familiarity with the clinical development process and sufficient subject area knowledge relevant to team topics.
- Exposure to clinical/preclinical trial data (preferably 1-2years)
- Knowledge of database specification for review and analysis.
- Experience in clinical/preclinical data management, specifically protocol assessment, case report form (CRF) including annotated CRF, clinical data management system (CDMS), study start up, edit check creation, data validation, database lock, reviewing source data.
- Experience interacting with a project team.
- Ability to effectively manage time, prepare for meetings, and prioritize project work.
- Working knowledge of clinical/preclinical research industry and familiarity with the clinical development process and sufficient subject area knowledge relevant to team topics.
- Familiarity with use of SAS data management tools.
- Experience monitoring and/or managing clinical trials preferred.
Language Ability: Requires strong oral and written communication skills.
Math Ability: Commensurate with Bachelor’s degree with emphasis on review and analysis of data.
Reasoning Ability:
- Exercise sound technical judgment when making decisions and adhere to external and internal policies and regulations.
- Ability to proactively address issues or challenges without being specifically directed.
- Use sound judgment when working with critical or confidential information.
Computer Skills:
- Proficient use of Microsoft Office Suite
- Proficient at using WebEx and teleconference technology to facilitate and manage teleconferences.
- Proficient use of standard office equipment, PC, copier, fax, printer, scanner, etc.
- Strong computer skills, including creation and management of relational databases.
Physical Demands:
- Regularly required to sit for long periods of time, and occasionally stand and walk about the facility.
- Regularly uses hands to operate computer equipment and other office equipment.
- Close vision required for computer usage.
- Occasionally required to stoop, kneel, and lift up to 25 pounds.
- Travel on occasion for out of town meetings (max 3-5%)
TO APPLY: Send resume/CV and a cover letter highlighting your interest in the position and how your skills and qualifications match the needs specified in the position announcement. Please include the job title in the subject line of correspondence. Application materials should be sent to HR@c-path.org.
Critical Path Institute is an equal opportunity employer.