Clinical Data Manager Resume

Career Summary:

Highly-dedicated, dynamic and certified Clinical Data Manager with over 6+ years of experience in maintaining updated databases, designing case report forms, and processing clinical trial data of patients via software. Expertise in operating various clinical data management software and adept in supervising the team to complete tasks within deadline.

Summary of Skills:

  • Thorough understanding of Clinical Data Management tasks with ability to evaluate the information in relation to the key project processes

  • Capable of handling a wide range of activities, including coordinating CRF designs, database management, ensuring validation programming to create quality data plans

  • Familiar with various software packages crucial in clinical data management such as Oracle Clinical, Medidata Rave, and possess a basis understanding of SAS programming

  • Ability to lead the team in coordinating project tasks, maintaining updated clinical databases and assisting to prepare accurate case report forms

  • Adept in keeping records, maintaining up-to-date data entries, and overseeing the quality of statistical programming process

  • Team player with exceptional organizational, managerial, and communication skills

Work Experience:

Clinical Data Manager

Health Decisions Inc., Boston, MA

November 2016 – Present

  • Monitoring all data management activities, and supervising the team for database development/maintenance

  • Attending internal as well as external team meetings, and providing specifications on case report forms

  • Testing clinical databases for ease of entries, assessing CRF data and producing listing reports using appropriate software package

  • Managing tasks related to initiation and approval of building, testing and validation of the clinical databases as well as assisting with the subsequent data changes when necessary

  • Ensuring the use of advanced computer software and database systems to validate, verify, and process clinical data

  • Assessing the database using clinical software such as Medidata, Clintrial for configuring, and implementing methods to record updated electronic data about the patients


Assistant Clinical Data Manager

ACADIA Pharmaceuticals Inc., Boston, MA

December 2014 – October 2016

  • Created and maintained project documentation, including Data Management Manual, CRF Completion Guidelines as well as work instructions for the assigned projects

  • Performed clinical data management tasks for the assigned studies in accordance with the company’s SOP policies and practices

  • Developed tools for performing quality check on clinical data, and raise flags for the identified discrepancies

  • Provided suggestions on data collection, management and analysis using appropriate data management software

  • Performed various data clinical activities, including reviewing available medical reports, CRF tracking, safety coding and maintaining an updated database

  • Supervised a team of 10 personnel by leading the development and implementation of clinical data management project deliverable according to SOP

Internship:

Clinical Data Associate

Pinpoint Pharma, LLC, Boston, MA

August 2012 – November 2014

  • Participated in the review of clinical study documents such as statistical analysis plan, clinical trial report, statistical outputs, etc.

  • Followed manager’s instructions to design and approve Case Report Forms (CRFs)

  • Processed clinical trial data using a range of computer applications

  • Supported data abstraction and data entry for the assigned clinical trials

  • Handled collection of data in accordance with SOPs and protocol specific processes

  • Participated in designing Electronic Data Capture (EDC) databases

  • Generated, resolved and tracked, queries to address problematic data identified during the data review activities, and applied proper modifications/corrections to the database

Education:

  • Diploma in Clinical Research & Data Management

    Boston University, Boston, MA

    2012

  • Bachelor’s Degree in Health Sciences

    Boston University, Boston, MA

    2010

Reference:

On request