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As a core member of the Clinical Team, the Project Data Manager is accountable for the leadership, planning and delivery of all Data Management activities within a project(s) to ensure the effective and efficient delivery of standardised quality data for clinical evaluation and statistical analysis.
Principle Accountabilities and Responsibilities:
Provides global leadership to one or more Project Data Management teams
Establishes Data Management resource, timelines, risk management and quality plans in line with overall project plan
Manages the delivery of Data Management activities in order to meet project plan(s)
Representation of Project Data Management team at the Clinical Team
Defines scope of work, provides direction and oversight of outsourced Data Management activities to ensure CRO and vendor delivery against contract
Identifies areas of best practice and process improvements, drives implementation and evaluation of standards across one or more Project Data Management teams. |
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Bachelors Degree
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5 years + |
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English : Speak / Write Fluently
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open-ended |
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unspecified |
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EU National |
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Basel |
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You’re someone who wants to influence your own development. You’re looking for a company where you have the opportunity to pursue your interests across functions and geographies, and where a job title is not considered the final definition of who you are, but the starting point.
University degree or equivalent.
Strong leaderships skills developed through leading global data management teams through all stages of clinical studies and high-lighted by a consistent achievement of team delivery against commitments and goals.
Experienced project manager, having led the development and implementation of risk management plans and resourcing plans for the data management activities of studies.
Proven experience of all aspects of data management including study start up: coordinating case report form design, database set up, validation programming and creating data quality plans, through to database lock, clinical evaluation and statistical analysis.
Understanding of thesaurus management, serious adverse event reporting, full query management and status reporting.
Knowledge of relational databases and experience using Clinical Data Management systems and tools - preferably Oracle Clinical.
Knowledge of global regulatory requirements such as ICH GCP and CFR 21 part 11.
Proven experience of vendor/CRO management and/or EDC preferable.
Experience of influencing and negotiating at all levels to achieve team delivery.
Self-motivated and achievement driven.
Excellent written and verbal English communication skills demonstrated by ability to present clear messages from complex information/data to all levels in the organisation.
If you are interested in this position, please apply online at http://careers.roche.com
Who to contact:
Contact HR: G. Foshag
Phone number: +41 61 68 80910 |
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At Roche, 80,000 people across 150 countries are pushing back the frontiers of healthcare. Working together, we’ve become one of the world’s leading research-focused healthcare groups. Our success is built on innovation, curiosity and diversity, and on seeing each other’s differences as an advantage. To innovate healthcare, Roche has ambitious plans to keep learning and growing – and is seeking people who have the same goals for themselves.
The headquarters in Basel is one of Roche’s largest sites. It is home to the Corporate Executive Committee, the Pharmaceuticals and Diagnostics Divisions and the global business functions. Roche Basel also covers the entire business chain from research, development and production through to marketing. Over 8,000 people from more than 60 countries work at the site. |
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