Clinical Data Manager Resume

PROFESSIONAL EXPERIENCE:

Clinical Data Manager

Confidential

Responsibilities:

Manages all internal aspects of clinical data management activities as CDM lead for
Oversees CROs and all activities that ensure the completeness and validity of the clinical trial database, including reviewing data management plans, edit check design and testing documents and query content
Reviews eCRF (Rave, Inform) data on an ongoing basis
Performs external data reconciliation
Monitors timelines to ensure data management deliverables are met
Prepares for and participates in Safety Review Committee
Manages 1 full time employee

Principal Consultant

Confidential

Responsibilities:

Worked as a high profile member of the project team to ensure excellent customer relationships are established throughout the study design, development, implementation and maintenance of the trial.
Functioned as the design expert to advise internal and external customers regarding best practice for IRT design.
Gathered and interpret customer request and translate these into design specifications including study randomization schemas and drug supply methodology.
Worked with the study team to scope effort and define timelines.
Actively contributed to the continuing development of the product function and improvement of the clinical design working practices
Advised customers to ensure that the study trial design is configured in such a way that it meets the customer's goals and offers the full benefits of IRT application.

Clinical Data Management Contractor

Confidential

Responsibilities:

Managed all aspects of clinical data management activities as CDM lead for
Oversaw all the activities that ensure the completeness and validity of the clinical trial database, including authoring the data management plan, edit check design and testing, data validation and query management
Defined data handling conventions, edit checks, quality acceptance and auditing criteria for electronic data as well as procedures for handling exceptions for violations to the standard metadata and identifies and requests additions to standard metadata
Represented data management on Clinical Trial Working Groups (CTWG)
Liaised with third - party vendors such as CROs, EDC vendors and central laboratories in a project-manager capacity
Performed SAE Reconciliation Independent Data Management Contractor, Averion International Corp. (now Aptiv Solutions)
Reviewed and cleaned CRF data on large oncology study
Generated listings utilizing Crystal Reports
Handled Sponsor inquires as requested
Provided ongoing study to new personnel

Clinical Data Analyst Contractor

Confidential

Responsibilities:

Clinical Data Manager II

Confidential

Responsibilities:

Reviewed CRFs through both automated edit checks and manual checks
Generated, reviewed and integrated queries
Designed effective/efficient CRFs (OmniForm)
Related CRF design to protocol and ensure consistency. Identified and suggested design for standard data types.
Created data entry guidelines and CRF completion guidelines
Developed and defined edit checks
Reviewed and contributed to database design specifications
Created tracking and ad hoc reports using Crystal Reports
Coded adverse events and medications using MedDRA and WHOMED
Performed database quality control audits
Interacted with external lab vendors regarding data collection processes/issues

Senior Study Coordinator/CRA

Confidential

Responsibilities:

Evaluated and tracked the eligibility of all patients seen in the Breast Oncology Clinic Reviewed and abstracted medical records (electronic and paper-based)
Reviewed clinical data for quality and completeness using reporting software
Prepared quarterly data for submission to the NCCN Breast Cancer Database
Reviewed and perform QA on all clinical data submitted to the NCCN
Trained staff on processes and procedures relating to study and the NCCN