Beschreibung
* Independently performs Biomarker Lab Data Management tasks in a timely manner, in compliance with the existing processes, the regulatory constraints and the needs of the department and global development projects.* Contributes to the process and technical framework to improve the data management conduct
* Efficiently communicates and manages the global interfaces to internal partners, such as experts / scientists from clinical development, biostatistics and the therapeutic areas
* Efficiently communicates and manages the interfaces to external partners world-wide, such as clinical research organizations, central laboratories, biomarker test centres, academic labs
* Develops and reviews specifications related to lab data management and sample information, such as data transfers, relevant sections in analysis protocols, clinical trial protocols, Informed Consent Forms
* Coordinates and performs data transfers with other functions (internal and external/collaboration partners)
* Performs data validations, including exhaustive checks, quality control, conformity to specifications, data cleaning
* Delivers data releases and reports to other functions, relevant sections of biomarker study reports and to the Clinical Database, integrating experimental data and clinical data
* Follows-up on queries raised while sample and data reconciliation
* Professional Master-/PhD-Qualification
* Experience in clinical data-management
* Excellent written and spoken communication skills
* Excellent project management skills, working on several projects in parallel
* Good interpersonal skills
* Attention to details
* Analytical thinker & problem solver
* Able to work autonomously and under time and work load pressure
* Ability to work in project teams
* Experienced in working in a regulated environment (GxP)
* Capability to ensuring compliancy to GCP and other relevant quality standards as per guidelines, regulations and company policies
Schlagwörter:
project management, clinical trial, scientific, communication, lab data, management, phd, master, interpersonal skills, global, world wide, pharma, pharmaceutical
Kontaktperson: Personalreferentin Frau Hatmane Berisha
FERCHAU Engineering GmbH
Niederlassung Darmstadt
Rösslerstr. 88
64293 Darmstadt