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Job Information
Job title

Clinical Data Manager

Company Adecco Technical
Wage between $0.00 - $0.00 Annually
Location United States, Washington, Snoqualmie
Employment type Full Time
Education Not Specified
Year Experience 4 - 5 Years of Practical Experience
Travel Not Specified
Published on 8/17/2009
Description
Clinical Data Manager

Job Status: 6 months , Contract Employment
Recruiter Contact: (see below)
Location: Snoqualmie, WA

Summary:
The Clinical Data Manager contributes to the conduct of clinical trials performed by the Clinical and Scientific Affairs Group (C&SA). The data manager is responsible for ensuring the functionality of the Electronic Data Capture (EDC) systems used in all trials. The data manager is expected to perform the duties in collaboration with the Clinical Project Managers and Clinical Statisticians.

Responsibilities/Scope:
Responsible for database development and data management using the EDC systems, involving other colleagues and external sources as required
Design, implement, validate, and maintain the available data systems
Manage vendors providing data base services (eg InForm)
Participates in protocol development & execution
Develop, review and test electronic case report forms (eCRF's) & data entry screens to ensure consistency with the study design and intended analyses
Review data handling plans and data checks for all clinical studies to ensure they meet regulatory requirements, and good clinical practice
Coordinates database requirements for internal and external studies with clinical project managers and clinical statisticians
Ensures data integrity for all studies
Develop programs that help in identifying data issues and outliers and communicate the findings to the person responsible for the data entry
Ensure data cleaning, editing and verification, and database lock
Develop programs to load data from external sources (eg laboratory data)
Perform interim and final databases audits.
Supports relationships with external investigators and staff
Align priorities with clinical project managers to meet timelines
Assist in study site training and monitoring, as requested
Resolve database-related issues at study sites
Provide formal updates regarding timelines, deliverables, including progress reports on database, data management, and programming tasks
Develop and review Standard Operating Procedures and Work Instructions
Assist with selection of a database and/or data capture system for clinical trials
Assist in the development of systems for sharing data within the company
Stay informed on current topics and new developments in clinical data management

Job Requirements:
BS degree in Computer Science, Information Technology or similar with at least four years of relevant experience, or a MS degree with at least 2 years of experience.
Knowledge of and expertise in using Electronic Data Capture (EDC) systems, general database requirement and data management for clinical trials required.
Experience with EDC system InForm preferred.
Experience in clinical study design, protocols and electronic case report forms required.
Knowledge of clinical research in dentistry/oral care research preferred.
Statistical expertise and working knowledge of SAS preferred
Ability to understand and comply with regulatory, ICH and GCP guidelines and internal Standard Operating Procedures
Detail oriented and well organized.
Works well on project team and cross-disciplinary environment
Ability to multitasking and to prioritize conflicting tasks in fast-paced environment
Technical and non-technical communication skills, both verbal and written

*Note:
Pending offer and acceptance, drug and background screening will need to take place at Adecco's expense.

Adecco is a Fortune Global 500 company and the global leader in Human Resources services. Registered in Switzerland, and managed by a multinational team with expertise in markets spanning the globe, the Adecco Group delivers an unparalleled range of flexible staffing and career resources to clients and associates. Adecco was created in 1996, following the merger of Adia (Switzerland) and Ecco (France), two leading personnel service firms with complementary geographical profiles.df-tc

Experience/Skills
See Above
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