Beschreibung
Wir, die Accessio IMS, suchen ab dem 15.04.2021 für unseren Kunden einen Freelancer Clinical Data Manager (w/m/d) in Vollzeit für ca. 12 Monate am Standort Raum Darmstadt.Eventual On SIte Support Needed/ Initial on Site Support not needed
Role Description:
Leading Data Management including centralized monitoring related activities within a complete clinical development program (Phase I-IV, Accountable and Project Leadership) for global or regional trials and/or programs with different complexity.
Ensures and tracks data quality of clinical database/deliverables (incl. CRF and non-CRF data) and submission readiness of the clinical data management deliverables and data packages (e.g. CDISC)
Project management of all clinical data management related deliverables by ensuring adherence to planned time, cost and quality.
Accountable for oversight of CROs in the execution of Phase I – IV clinical trial(s).
Drives and leads the successful execution, oversight and approval of all DM related clinical trial documents and operational plans (e.g. Data Management Plan) of clinical trials using strong project management, leadership, and organizational skills.
Preferred Candidate Profile:
Proven experience as Clinical Data Manager in the pharmaceutical/biotechnology industry, equivalent to 8 years. Substantial project management experience.
Successful completion of multiple studies from beginning to end providing a full scope of DM experience
Proficiency with data management systems such as InForm™, Rave or other industry electronic data capture systems and other systems such as ePRO, eHR, etc.
Comprehensive knowledge of ICH-GCP and major health authorities (e.g. FDA, EMA, CFDA, PMDA) regulations
CDISC fundamentals knowledge
Knowledge of quality assurance
Proficient Computer Skills e.g. word processing, spreadsheets
Knowledge of SAS, SQL or other programming languages
Knowledge of medical terminology, Coding systems, SAE reconciliation
Excellent knowledge of regulations and guidance about clinical development and the systems used in this context
Able to identify and define problems, extract key information from data and develop workable solutions for the problems identified, to verify root cause and develop solutions to resolve the problems identified.
Makes decisions autonomously and demonstrates superior critical thinking skills.
Anticipates issues/risks, develops mitigations and corrective actions.
Analyzes clinical study and investigative site risks and implements corrective actions, where required.
Utilizes data/metrics to establish key performance and quality indicators to oversee performance and anticipate areas of concern across the clinical study continuum.
Utilizes functional expertise and cross-functional resources proficiently to drive study execution.
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