Clinical Data Manager

Who are we?

Compugen is a clinical-stage therapeutic discovery and development company utilizing its broadly applicable, predictive computational discovery platforms to identify novel drug targets and develop first-in-class therapeutics in the field of cancer immunotherapy. Our therapeutic pipeline consists of immuno-oncology programs against novel drug targets we discovered computationally.

We are looking for:

As we advance our pipeline, we are looking for a highly motivated Clinical Data Manager (CDM) who will be responsible for all aspects of data management for our clinical trials ensuring the trial’s raw data transforms into a reliable, high-quality dataset ready for statistical analysis and regulatory submission. The data manager will report to the Senior Director of Clinical Development.

Responsibilities:

• Vendor Oversight: Provide vendor oversight and participate as the primary data management representative on cross functional project teams and ensure effective communication exchange (including statistics, clinical development, safety, clinical operations and clinical pharmacology).
• Electronic Case Report Form (eCRF) and Database Design: Oversee study database design to align with the clinical trial protocol and CRF setting to ensure efficient and accurate data collection including database build, updates, UAT and data entry manuals .
• Data Validation, UAT and Quality Control: review and approve data validation checks and edit checks for automated identification of discrepancies and inconsistencies. Lead oversight of data migrations and data transfers.
• Data verification and review: Generate data outputs – e.g. listings, summaries, for ongoing data review and cleaning. Generate data queries and track open data queries until resolution.
• Participate in preparation of new Standard Operating Procedures (SOPs), Developing and maintaining the Data Management Plan (DMP), CRF Completion Guidelines (CCGs), data transfer specifications, and user acceptance testing (UAT) plans.
• Documentation: Ensure relevant documents and plans are filed in the Trial Master File (TMF) (internal and/or CRO TMF), maintain comprehensive and audit-ready documentation. Support audits and inspections by internal QA or regulatory authorities.
• Regulatory Compliance: Ensure all data management activities and documentation adhere to relevant regulatory guidelines, including GCP, ICH, and FDA regulations.
• Collaboration: Work closely with cross-functional in-house and CRO teams, including clinical operations, clinical development, pharmacovigilance, statistics and project management to support data analysis and reporting.
• Provide data status reports and metrics to study leadership

Qualification:

• Bachelor's degree in life science, computer science, or related field.
• At least 5 years of experience in clinical data management within the pharmaceutical, biotech, or medical device industry.
• Previous experience in oncology trials- advantage.

Technical Expertise:

• Excellent working knowledge of data management practices; with expertise in EDC systems particularly Medidata RAVE, experience in development of eCRF design are required and prior solid tumor oncology experience is preferred.
• Knowledge of SDTM models and experience in transforming raw data into approved standards; and familiarity with applicable U.S. and global regulatory requirements.
• Skills in programming and generation of data listings and summary tables using SAS and other languages is required.
• Knowledge of Good Clinical Practices and regulatory requirements for the conduct of high-quality oncology clinical trials is required.
• High performer with strong organizational skills in a cross functional matrixed system and willing to help where needed, ready to partner and work closely across the different functions on the team to drive key deliverables with high quality and efficiency.