The Clinical Research Associate 2 (CRA 2) independently conducts site monitoring/management visits in accordance with regulations and department plans and procedures.
Compensation
The annualized base salary range for this role is $80,700 to $126,100 and the position is eligible for an annual bonus.
Responsibilities
Conducts Site Qualification, Initiation, Interim Monitoring, Close-Out visits and activities independently
Ensures records are complete and consistent with governing regulations
Uses electronic data capture system and other monitoring tools to review and ensure accurate and complete clinical data collection
Assists sites with site-level IRB submissions, queries and documentation
Establishes and maintains regular communication with clinical sites
Support the international roll‑out of Telix’s approved prostate cancer imaging agent and advance the portfolio of late clinical‑stage products by analysing and interpreting complex clinical and non‑clinical data, including medical images, to develop predictive models using statistical and machine learning techniques.
Responsibilities
Analyze and interpret clinical data generated from Telix radiopharmaceuticals, including imaging (PET, SPECT), biomarker, and patient outcomes data, to inform clinical outcomes and decision making.
Work with cross‑functional teams to integrate diverse data sources, including clinical trial data, medical imaging, and electronic health records, into cohesive datasets suitable for analysis.
Apply machine learning techniques, particularly using automated machine learning (AutoML) and/or “zero code” platforms, to analyze large‑scale data from clinical studies, including image processing, diagnostic prediction, and personalized medicine algorithms.
Develop clear and informative visualizations to communicate data insights to both technical and non‑technical stakeholders, including clinical teams, regulatory agencies, and senior management.
Ensure that all data science activities comply with industry standards and regulatory requirements (e.g., FDA, EU CE Mark), maintaining data integrity, privacy and security throughout.
Requirements
Master’s or PhD in a quantitative discipline (e.g. Data Science, Computer Science, Statistics, Bioinformatics, Computational Biology, Mathematics, Physics) or a related field is preferred.
Ensure the quality and regulatory compliance of computerized systems, related IT operations and IT suppliers, supporting validation and qualification activities throughout system maintenance and development.
Locations (2)
Bangalore, Karnataka, India
Gdańsk, Pomorskie, Poland
Responsibilities
Prepare and maintain validation documentation, including plans, risk assessments, traceability, and reports
Assess validation impact of system changes and coordinate updates to deliverables
Prepare and review validation test cases and support controlled test execution
Support investigations of validation deviations and track CAPA actions
Perform scheduled periodic reviews of validated systems
Requirements
University degree in IT, natural sciences, or related field
As Manager, Clinical Data Management, you will oversee and work alongside a team of end-to-end data custodians and play a key role in managing data and ensuring its accuracy, completeness, and compliance with regulatory standards while providing data management support to study teams.
Compensation
Salary structure and Flexi basket, Provident fund of 12%, Gratuity scheme
Responsibilities
Leads, mentors and develops a clinical data management team through direct line management
Provides training on Data Management procedures
Monitors performance to ensure the team are operating at the highest level to design and deploy clinical databases for multiple clinical imaging studies
Managing project timelines, resources, and deliverables to ensure timely and successful completion
Acts as resource manager for dedicated therapeutic area
