Senior Clinical Data Manager

Location
San Diego, California
Posted
Sep 25, 2020
Discipline
Clinical, Clinical Data
Required Education
Bachelors Degree
Position Type
Full time

Position Summary

The Senior Clinical Data Manager is responsible for performing data management vendor oversight, complex clinical data review, discrepancy management, oversight of external data reconciliation, and database lock. This position is responsible for overseeing development and maintenance of the EDC system for new clinical studies, as well as all accompanying documentation, throughout the study lifecycle. This individual will report progress for data management activities on assigned studies with proactive risk identification to ensure timely locking of databases, and provide ongoing identification and resolution of errors and inconsistencies. This position reports to the Director of Clinical Data Management.

 

Responsibilities

  • Perform extensive manual data review on complex clinical studies to ensure protocol compliance
  • Oversee study team participation in a “rolling” data review process intended to clean subject data as subjects come off study
  • Meet regularly with the study team to review data cleaning metrics (via a subject cleaning tracker) to ensure data cleaning activities meet timelines in preparation for recurring data adjudication meetings
  • Safeguard data integrity via appropriate data management processes such as manual data listing reviews, query review and generation for missing or discrepant data, evaluating data outliers, performing data quality checks, and database updates
  • Review data issues with internal staff, external monitoring vendors, and site staff to resolve discrepant data issues and maintain a clean database
  • Perform User Acceptance Testing (UAT) on new, or modified, clinical study databases
  • Review clinical study startup documents: Data Management Plan (DMP), Case Report Form Completion Guidelines (CCGs), Data Validation Specifications (DVS) including system queries and manual reviews, Data Transfer Agreements (DTA), etc.
  • Utilize operational data and analytical tools to optimize execution of assigned clinical trials and to identify key areas of risk that may require escalation

 

Minimum Qualifications      

  • Bachelor’s degree, combination of relevant education and applicable job experience may be considered
  • At least 5 years of increasing clinical data management experience in a pharmaceutical/biotechnology or CRO environment
  • Ability to read and understand complex clinical study protocols, and perform intricate manual data review per clinical study Data Validation Specification (DVS) requirements
  • Some level of prior familiarity/experience with SAS computer programs in order to be able to, at a minimum, run a SAS program to produce data review reports
  • Previous experience with data management vendor oversight
  • Expertise with EDC platforms (e.g., Medidata Rave, IBM Clinical Development)
  • Familiarity with ICH GCP as well as industry practices and standards (CDISC, SDTM, CDASH)
  • Demonstrated ability to manage a complex workload and prioritize tasks based on program goals
  • Ability to collaborate effectively with study team, cross-functional members, and external partners
  • Self-motivated with a sharp attention to detail
  • Flexibility/adaptability to work in a fast-paced and dynamic environment

 

The content of this position description provides a summary of the general nature of the job and may include other duties as assumed or assigned.   The Company reserves the right to change this description at any time and require the employee to perform other tasks as required due to business needs.

Cidara Therapeutics is an EEO/AA/Disability/Vets Employer and an E-Verify Company