Clinical Data Manager Resume

SUMMARY

Highly motivated clinical data manager with clinical research expertise in NIH and pharmaceutical industry funded studies.
Outgoing individual with solid data management experience and strong communication skills. Inquisitive self - starter, who takes initiative, possesses the ability to prioritize and manage multiple projects at the same time and develop sound solutions to complex problems.

PROFESSIONAL EXPERIENCE

Clinical Data Manager

Confidential

Responsibilities:

Review protocol /grant proposals and suggest refinements.
Develop Data Management plans and data review plans.
Create CRF (paper and eCRF) and data dictionary (data specification and edit check specification) to develop protocol specific validations.
Collaborate with IT for all EDC database development activities, including the development of specifications for edit checks, creation of test data, and ensure edit checks are programmed and tested in a timely fashion.
Perform quality control audits to ensure accuracy, completeness, or proper usage of clinical systems and data.
Train study teams for EDC database and CRF completion guidelines.
Generate, issue, track, and respond to data queries to facilitate timely query resolution.
Review data listings and data validation reports for data discrepancies.
Develop specifications for transfer of electronic data from non-EDC sources, ensure data is transferred according to the specifications, and reconcile data with EDC database.
Provide data trends and status reports to clinical team and identify possible solutions for efficiencies.
Perform independently all data management functions to ensure timely and quality database interim/final locks.
Participate in quality assurance audits conducted by study sponsors, federal agencies, or specially designated review groups.
Prepares final study documentation to archive study database.

Research Associate

Confidential

Responsibilities:

Responsible for QC in various data/information from study sites based on Standard Operation Procedures (SOPs) for study protocols
Monitored and updated central database to ensure that all data is being processed timely.
Provided technical oversight for integrating new technology or new initiatives into data standards and structures
Assisted in database and documentation change control and the finalization process for interim or final data analysis.
Ensured that the requirements for data transfers and integration with other systems are defined.
Provided training and mentoring for research team members in data entry.
Prepared essential documents for IRB submission and renewals, study status updated reports, study summary and annual lab reports to NIH.
Formatted, presented and wrote abstracts or journal articles for publications or presentations at society meetings.

Confidential

Responsibilities:

Collected data from research subjects, performed data entry and update.
Performed routine data review to ensure quality and identify data trends/issues.
Formulated clinical data achieved process for new techniques.
Guided research team on data capturing methods; facilitated team review and resolution of technical data issues requiring clinical and/or regulatory input.
Evaluated and analyzed data submitted by various parties to ensure it meets the criteria set by the study protocol.
Oversee the review of incoming CRFs for completeness, consistency and clarity; ensured activities leading to database lock are followed and documented including SAE reconciliation.
Responsible for providing timely and professional ongoing quality management of clinical trial data by identifying errors/inconsistencies in CRF data and ensuring their resolutions in order that databases can be declared clean and locked according to strict performance standards.
Designed CRFs, including the development of requirements, specifications, designs, and training materials for CRFs, utilizing paper and electronic formats; developed study specific SOP.
Managed and tracked all aspects of data project timelines and quality issues.
Managed the filing and storage of documents; submitted status reports on a regular and as needed basis; developed investigator meeting presentations.
Quickly resolved all outstanding queries; interacted with primary physicians, nurses and pharmaceutical sponsors.
Analyzed clinical data and wrote professional abstracts and/or manuscripts.

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