Catalyst Clinical Research is at the forefront of delivering customizable solutions to the biopharmaceutical and biotechnology industries. Known for its flexible service model, innovative technology, and global presence, Catalyst Clinical Research advances clinical studies through Catalyst Oncology, a full-service oncology CRO, and Catalyst Flex, offering multi-therapeutic global functional and CRO services. With a customer-centric approach and expert team members, Catalyst Clinical Research stands as a leader in clinical trial advancements.
Responsibilities in the Role
The Senior Clinical Data Coordinator (Sr. CDC) plays a vital role in the Development Operations, Data Management Team at Catalyst Clinical Research. Key responsibilities include:
- Data Management Support:
- Preparing, validating, processing, and maintaining clinical data for regulatory submissions or publications.
- Assisting in developing edit specifications aligned with global medical and therapeutic standards.
- Conducting user acceptance testing (UAT) on eCRF builds and edit specifications.
- Supporting the data coding schedule and collaborating with data coding specialists for timely execution.
- Data Quality Assurance:
- Performing manual data listing reviews and initiating queries as needed.
- Participating in SAE reconciliation and resolving discrepancies for database consistency.
- Conducting blind review meetings and assisting in generating study report listings per ICH guidelines.
- Collaboration and Communication:
- Coordinating query management system functions and processing data transfers from external vendors.
- Reviewing site responses to queries and addressing inconsistencies effectively.
- Attending and occasionally leading team meetings, along with providing meeting minutes.
- Process Improvement and Training:
- Supporting the development of Clinical Data Coordinators through training.
- Assisting with eCRF design and providing peer reviews.
- Acting as a backup to the Lead Data Manager (LDM) for internal and external study teams.
Qualifications for the Role
To succeed as a Senior Clinical Data Coordinator, you must meet the following qualifications:
- Education:
- A bachelor’s degree in a related discipline with three years of relevant experience.
- Alternatively, a high school diploma with four years of related experience.
- Experience:
- Proven experience in clinical data coordination or data management roles.
Key Skills
The role demands a combination of technical proficiency, analytical abilities, and interpersonal skills, including:
- Expertise in Microsoft Office Suite.
- Exceptional written, oral, and presentation skills.
- Strong problem-solving, organizational, and analytical capabilities.
- Ability to manage multiple projects and adapt to changing priorities.
- Team-oriented mindset with flexibility and creativity.
- High standards of discretion and sound decision-making.