Doing now what patients need next. A pioneer in the development of blood glucose monitoring and insulin delivery systems, Roche Diabetes Care is committed to helping people with diabetes live lives that are as normal and active as possible and helping healthcare professionals manage their patients' condition in an optimal way. The ACCU-CHEK portfolio-from blood glucose monitoring through information management to insulin delivery - offers innovative products, services and comprehensive solutions for convenient, efficient and effective diabetes management.
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What to expect:
As the Senior Clinical Data Manager (CDM) you will be responsible for the development, execution and oversight of all data management plans, deliverables, and processes on assigned Diabetes Care Clinical Study Services projects. You will also serve as the subject matter expert and primary interface between global Clinical Study Services and Biostatistics groups, local study teams and/or CRO's relative to all data within specific studies, databases, and/or electronic data capture (e-DC) and case report form (e-CRF) applications and systems. You will lead and oversee data management activities including CRF and database development based on study protocols and needs, periodic data quality checks, data queries, data cleaning and discrepancy management.
You will coordinate the formatting and storage of study data per study protocol, standard operation procedure (SOP), area work instructions and post-production change management to maintain high quality data records. You will also work with Study Managers and Clinical Research Associates to provide both in-house and on-site user training and secondary user support, as required on individual studies. You will support Quality and Regulatory compliance initiatives on all projects, and handle the coordination of change requests during the life-cycle of study data handling tools.
You should possess a specialized and in-depth comprehensive knowledge and experience in a particular field, or business area. Your duties are varied and complex, often involving research, analysis and solution development. You will provide direction on issues of area of expertise and assist department leadership in setting strategic direction. The regular use of originality and ingenuity will be required. You will also plan, conduct and oversee work involving the largest and most important/complex projects. You will not supervise, but provide direction to team on projects and assignments. You will work with minimum supervision and review progress with management.
You will also be responsible for maintaining and continuously improving the quality system and achieving quality objectives through daily actions.
Guides and advises study teams on the definition of the clinical data management and the study management in the paper and/or electronic systems.
Reviews protocol on clinical/technical data management and system implications.
Creates clinical data management plan.
Collaborates globally as needed on the design, documentation, testing and implementation of clinical data studies.
Ensures the use of standards and alignment of clinical data management when supporting studies.
Uses tools and provides guidance in order to execute timely clinical data reconciliation, data cleaning, and data analysis.
Responsible for timely delivery of clean, complete high quality data for analysis.
Who you are:
Bachelor's degree in life science, computer science or related field
Significant experience (3-5 years) in data management and analysis, study management and reporting of clinical study results
Experience in database design, construction and verification/validation
Demonstrated leadership skills in coordinating data workflow within clinical studies
Ability to work in an efficient and collaborative fashion with multi-disciplinary teams
Strong communication and interpersonal skills
Knowledge of GCP, GCDMP, 21CFR Part 11 CSV Methodology, CDISC, CDASH
Knowledge of and/or experience with commercial electronic data capture/CRF software is a plus
Clinical Research, Data Management certification is a plus
Business level fluency in English
Apply now - we are looking forward to it!
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For a complete application, please include a current CV, a letter of motivation suitable for the position and relevant references (please in English language). Before submitting your application, please note that no further documents can be added subsequently.
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