Senior Data Manager

 

OncoCyte is focused on developing liquid biopsy molecular diagnostics to address unmet needs in the diagnosis and treatment of cancer.  We currenlty have an exciting opportunity for a Sr. Data Manager as a critical member of the clinical team.

 

SPECIFIC DUTIES, ACTIVITIES AND RESPONSIBILITIES INCLUDE, BUT ARE NOT LIMITED TO:

  • Work closely with team members to ensure that clinical data captured is complete, consistent, and accurate.
  • Perform study startup activities such as study protocol review, Clinical Data Management Plan (CDMP) development, and EDC set-up, while collaborating with Clinical Technology staff to integrate with external systems.
  • Manage study conduct activities including facilitation of study team data review, documentation of data handling decisions, issuance of data queries and resolution of data discrepancies.
  • Utilize programming skills and appropriate tools to provide information as required by study team members.
  • Lead data locking efforts, ensuring that study team members have executed according to the CDMP.
  • Ensure that data integrity is maintained throughout the data lifecycle for sources including clinical data and external bio-specimen storage data.
  • Ensure that documentation is maintained in a state of constant audit-readiness and filed in the Trial Master File.

 

EDUCATION & TRAINING:  

  • A Master’s degree in Biological Sciences, Chemistry, Computational or Applied Mathematics, Computer Science, Healthcare Management, or any related field plus (8)+ years of experience in the Data Management field with demonstrated progressive career growth.  A Bachelor’s Degree with (10+) years of experience in the Data Management field with demonstrated progressive career growth will also be considered.

 

EXPERIENCE:

  • Experience, knowledge, or training must include a minimum of two (4) years of the following: Clinical Data Management Plan (CDMP) development; Electronic Case Report form (eCRF) development; Edit Check Development; Data Quality and Review Plan; and, User Acceptance Testing.
  • 25-30% travel will be required.

 

SPECIAL REQUIREMENTS:

  • Experience, knowledge, or training must include two (3-4) years of the following: Clinical Data Management Plan (CDMP) development; Electronic Case Report form (eCRF) development; Edit Check Development; Data Quality and Review Plan; and, User Acceptance Testing.

 

WORK ENVIRONMENT:

The work required for this position is to be performed on-site in a formal office or in a home-based office.  

 

Please send your resume to careers@oncocyte.com if you would like to be part of this growing and dynamic team.