Catalyst Clinical Research, LLC

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.

The Senior Clinical Data Coordinator (Sr. CDC) at Catalyst Clinical Research, a leading provider of customizable solutions to the biopharmaceutical and biotechnology industries, plays a crucial role in the Development Operations, Data Management Team. In this position, you will be responsible for providing data management support for all assigned studies. Your primary tasks will include preparing, validating, processing, and maintaining clinical data to support submissions to international regulatory agencies and the publication of manuscripts. You will utilize EDC and SAS software to accomplish these tasks effectively. As a Senior Clinical Data Coordinator, you will assist in the development of edit specifications based on global medical standards, therapeutic area standards, and the study protocol to ensure data accuracy. You will also be involved in user acceptance testing on eCRF build and edit specifications, as well as creating supporting DM process documentation. Additionally, you will collaborate with data coding specialists to ensure timely coding and support/maintain quarterly coding review cycles. Your role will also involve performing manual data listing reviews, submitting queries, and assisting with user acceptance testing of lab data standards. You will evaluate the quality of lab data entry, address inconsistencies with sites and CRAs, and support the SAE reconciliation process. Furthermore, you will apply criteria for subject stage gate of No More Issues (NMI) and coordinate the resolution of medical and statistical queries. In addition to these responsibilities, you will assist in developing blind review reports, generating study report listings, coordinating the query management system functions, and performing final patient review and database lock activities. Your role may also include coordinating the processing of scheduled data transfers from external vendors and ensuring data quality through review of query responses. To excel in this role, you should have a Bachelor's degree in a related discipline with at least three years of related experience or a high school diploma with four years of related experience. Proficiency in Microsoft Office Suite, excellent communication and presentation skills, strong organizational and analytical abilities, and the capacity to manage priorities and workflow effectively are essential for success in this position. You should also demonstrate versatility, flexibility, and a commitment to excellence while working both independently and as part of various teams and committees. If you are a creative, innovative team player with good judgment and a high level of discretion, and you thrive in a dynamic and challenging environment, we invite you to apply for the role of Senior Clinical Data Coordinator at Catalyst Clinical Research.,