Sr Clinical Data Coordinator

Catalyst Clinical Research

• Assist in the development of edit specifications, based on any available global medical standards, therapeutic area standards, and the protocol, used to clean the study.
• Performs user acceptance testing (UAT) on eCRF build and edit specifications.
• Creates supporting DM process documentation to LDM and/or performs peer review of documentation, including updating documentation.
• Support the coding schedule defined in the data management plan. Collaborate with data coding specialists on a regular basis to guarantee timely coding.
• Supports/maintains quarterly coding review cycles.
• Performs manual data listing reviews and submits queries as appropriate.
• Assist with and/or performs user acceptance testing of lab data standards.
• Evaluates quality of lab data entry and addresses inconsistencies with sites and CRAs as applicable.
• Assists in the SAE reconciliation process. This may include coordination with medical experts and Global Drug Safety. Follow up on discrepancies and resolve so both databases are consistent.
• Applies criteria for subject stage gate of No More Issues (NMI). Also, must coordinate and review medical and statistical queries and certify they are adequately resolved.
• Assist in the development of a blind review report and conducting a blind review meeting to assign patient validity.
• Assist in developing and generating study report listings according to ICH and if present company guidelines.
• Coordinate the query management system functions.
• Perform the final patient review and database lock activities.
• Assist in coordinating the processing of scheduled data transfers (PK/PD data, imaging data, Laboratory data) from external vendors and performs relevant review/reconciliation.
• Review query responses and ensure data quality.
• Reviews Site responses to queries and evaluates the necessity of a re-query. If applicable, communications with Site Coordinators are performed for resolution.
• Attends and may lead internal and external team meetings.
• Reviews and/or provides meeting minutes.
• Supports training and development of Clinical Data Coordinators.
• Assists with eCRF design. May be required to develop the eCRF and/or provide peer review.
• May serve as a back up to the LDM for internal and external study teams.
  

Education

Experience

Required Certifications

Required Skills

• Proficient with Microsoft Office Suite.
• Excellent written and oral communication skills.
• Excellent presentation skills.
• Strong organizational, problem-solving, and analytical skills.
• Ability to manage priorities and workflow.
• Versatility, flexibility, and a willingness to work within constantly changing priorities.
• Proven ability to handle multiple projects and meet deadlines.
• Strong interpersonal skills.
• Ability to deal effectively with a diversity of individuals at all organizational levels.
• Commitment to excellence and high standards.
• Creative, flexible, and innovative team player.
• Ability to work independently and as a member of various teams and committees.
• Good judgement with the ability to make timely and sound decisions.
• Ability to be discreet with sensitive company information.