Seeking Clinical Data Manager, for a leading biostatistical consulting firm, specializing in statistical consulting to medical device and pharmaceutical companies located in Modiin.

 

Position Responsibilities:

• Database design (EDC Programming).

• Primary contact on all data management study-specific issues.

• Actively participates in protocol and CRF review with clients, providing suggestions regarding the ability to capture protocol information in the database successfully.

• Responsible for the entire data management process from study set-up to study close-out. Participates in study start-up activities, including development, review, and approval of eCRF requirements, EDC database specifications, Data Transfer Specifications, eCRF completion guidelines, Data Management Plans, Data Validation Specifications, and User Acceptance Testing.

• Understanding GCP/ICH guidelines and FDA regulations, as applicable to data management.

• Provides oversight and resolves all issues in data management study processing activities including CRF tracking and data entry, integration of external electronic data (e.g., lab data) with clinical database, data validation and review, query processing and resolution, adverse event and medication coding, SAE reconciliation, database lock and database QC audits.

• Initiates SOP updates and provides specifications for DM systems/tools and process enhancements.

 

Education, Skills, Knowledge, and Experience:

• Bachelor’s degree, in relevant areas (e.g., computer sciences, statistics, biology).

• Candidates must be fluent in English (both verbal and written).

• Good knowledge of the clinical trial process and clinical development, data management, biometrics, and systems applications to support operations preferred.

• Technical expertise: Design Screens & Program Edits experience using EDC and hybrid CDM systems is a plus.

• Practical knowledge of ICH, FDA, GCP, and GDPR regulations and guidelines.

• General knowledge of industry standards and best practices such as CDISC, CDASH, SDTM.

• Knowledge of and experience with MedDRA and WHO Drug data dictionaries is a plus.

• Ability to work in a team environment.

• Good time management skills and the ability to work to tight deadlines whilst maintaining the highest standards of quality work.

• Ability to effectively manage a variety of Data Management tasks for multiple clinical studies at different stages of activity.

• Ability to work independently and resolve issues.

• Ability to acquire and apply new technical skills.

• Computer programming proficiency.

 

We offer:

• A professional and pleasant work environment.

• To improve knowledge in clinical trials (and in wider areas).

• Exposure to interesting projects and a variety of clientele.

• Good conditions for the suitable candidate.

 

Please send CV to: anat@ldbiostats.com