Clinical Data Manager

Role Summary

The Clinical Data Manager is an expert in clinical data management with demonstrated capability in building and maintaining clinical trial databases. They contribute to process improvements and initiatives within the Biometrics department as well as mentor and train junior staff members as applicable.

Responsibilities

• Create and/or review study-specific electronic or paper Case Report Forms (CRFs) using prior knowledge, protocol-specific information, and departmental standards. Work efficiently to incorporate core clinical team input and produce CRFs in a timely manner.
• Configure, migrate, and test electronic data capture (EDC) databases based on internal procedures, study requirements, and system best practices. Serve as a database manager for the study-specific clinical team, including the compilation of edit checks.
• Develop database requirements for use by EDC vendors. Serve as a study database manager and work with vendors to obtain deliverables in a timely manner.
• Create and/or review study-specific data management and database documentation, which may include:
  • Data Management Plan
  • CRF Completion Guidelines
  • Coding Guidelines
  • Annotated CRFs
  • Edit Check Specifications
• Attend study-specific team meetings and produce status reports and requested metrics, which may include query information or data trends.
• Perform data review and query generation/closure.
• Perform coding of verbatim terms such as adverse events and concomitant medications. Collaborate with medical scientists for coding, consistency, review, and approval. Incorporating coding files into the clinical database.
• Participate in the development of new processes or revision of existing processes.
• Train internal colleagues in clinical data management in either informal or formal settings as needed.
• Train Investigators and/or Study Coordinators at Investigator Meeting on the CRFs, the EDC system, and the CRF completion guidelines as needed.
• Provide data management expertise and support to the clinical teams using data management best practices.
• Provide analytical insight into data management strategies and advise the internal team with tactical strategies accordingly.
• As necessary, provide work direction, guidance, mentoring, influence, and support to junior staff. Train junior staff in more complex clinical data management processes.
• Perform other special projects and duties as requested.

Qualifications

• Bachelor‚Äôs Degree in a science-related field with 4+ years of experience; or
• High school diploma with 8+ year of relevant experience.
• 4+ years of clinical data management experience required.
• Experience working with EDC clinical databases required.
• Veeva Vault CDMS and TrialMaster experience preferred.
• MedDRA and WHO Drug coding experience preferred.

Skills

• Working knowledge of clinical research, Good Clinical Practices, and regulatory requirements
• Knowledge of CDISC/STDM standards
• Excellent English verbal and written communication skills; good organizational and interpersonal skills

Education

• As listed in Qualifications (Bachelor‚Äôs degree or equivalent experience).

Additional Requirements

• This position works onsite or remote based on the candidate‚Äôs location
• Regular work schedule is Monday ‚Äì Friday, within standard business hours. Flexibility is available with manager approval.
• Must possess mobility to work in a standard office setting and to use standard office equipment, including a computer
• Lift and carry materials weighing up to 20 pounds