Sr Clinical Data Coordinator

Catalyst Clinical Research provides customizable solutions to the biopharmaceutical and biotechnology industries through Catalyst Oncology, a full-service oncology CRO, and multi-therapeutic global functional and CRO services through Catalyst Flex. The company's customer-centric flexible service model, innovative technology, expert team members, and global presence advance clinical studies. Visit CatalystCR.com.

Job Description

The Senior Clinical Data Coordinator (Sr. CDC) is a key member of the Development Operations, Data Management Team. The Senior Clinical Data Coordinator will provide data management support for all assigned studies. The Sr. CDC prepares, validates, processes, and maintains clinical data in support of submissions to international regulatory agencies or publication of manuscripts through the use of EDC and SAS software.

• 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.

N/A

Education: Bachelor’s degree in related discipline and three years of related experience; or high school diploma and four years of related experience.

Experience: See “Education.”

Required Certifications: N/A

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.