Are you an experienced clinical data professional looking to advance your career? Catalyst Clinical Research is hiring a Senior Clinical Data Coordinator (Sr. CDC) in Thiruvananthapuram, India. This role offers an excellent opportunity to work with a global clinical research organization, leveraging your expertise in data management and compliance.
About Catalyst Clinical Research
Catalyst Clinical Research is a global Contract Research Organization (CRO) specializing in oncology and multi-therapeutic clinical trials. The company provides flexible, customer-centric services, ensuring efficient trial execution with cutting-edge technology and experienced professionals. Catalyst offers a collaborative work environment that fosters professional growth and innovation in clinical research.
Job Responsibilities
As a Senior Clinical Data Coordinator, you will play a crucial role in managing and processing clinical trial data to ensure accuracy, consistency, and compliance with regulatory requirements. Your key responsibilities include:
Data Management & Processing
- Develop, validate, and maintain clinical trial data within Electronic Data Capture (EDC) systems.
- Conduct User Acceptance Testing (UAT) on eCRF builds and edit specifications.
- Perform manual data listing reviews, generating queries where necessary.
- Manage query resolution to maintain data integrity.
Regulatory Compliance & Quality Assurance
- Ensure compliance with ICH-GCP guidelines and company SOPs.
- Collaborate with the Global Drug Safety team to reconcile Serious Adverse Events (SAE).
- Assist in preparing safety reports and regulatory documentation.
- Support internal and external audits by providing necessary data insights.
Collaboration & Training
- Work closely with clinical research teams, site coordinators, and biostatisticians.
- Assist in eCRF design and review.
- Provide training and mentorship to junior data coordinators.
- Support study report generation for regulatory submissions.
Required Qualifications & Skills
To qualify for this role, you must have:
Education & Experience
- Bachelor’s degree in Life Sciences, Biotechnology, Pharmacy, or a related field.
- Minimum 3+ years of experience in clinical data management.
Technical Skills
- Proficiency in Electronic Data Capture (EDC) systems.
- Strong knowledge of Microsoft Office Suite, SAS, and clinical data software.
- Familiarity with clinical trial regulations (ICH-GCP, FDA, EMA).
Soft Skills
- Strong analytical and problem-solving abilities.
- Excellent communication and collaboration skills.
- Ability to manage multiple projects and meet deadlines.