Manager of Clinical Data entry - Mahwah, NJ

If not you, would you know someone???

This is a specialized job, and requires experience in either Medical
Devices /Engineering, Bio-tech, bio-pharmaceutical.

Salary to about 125K

Manage Clinical Data Entry staff, SAS Programmers, Database Developers,
and Data Managers. Identify and implement process improvements and
participate in key departmental business initiatives. Ensure overall
compliance to FDA and other applicable regulatory requirements, industry
standards, and internal departmental Standard Operational Procedures
(SOPs).

* 8+ years of experience in clinical data management or related
discipline within pharmaceutical or medical device company
* Applied knowledge of drug and/or medical device study
development
processes
* Demonstrated organizational, communication, and time management
skills
required
* Applied knowledge of database management systems, personal
computer
systems and desktop applications required; demonstrated experience
utilizing NetRegulus, Clintrial or Oracle Clinical preferred
* Applied knowledge of Food and Drug Administration (FDA)
regulations,
International Conference Harmonization and Good Clinical Practices
guidelines as they apply to clinical studies and clinical data
management
* Demonstrated experience in developing and managing budgets
* Demonstrated experience in managing staff in a clinical data
management environment
* Demonstrated experience in reviewing clinical data listings,
study
protocols and statistical analysis plans

* Recruit, hire, train, manage, develop and motivate staff to
ensure
proper support for all ongoing clinical studies
* Complete mid and year end performance evaluations and
development
objectives for all direct reports
* Manage Clinical Operations budget
* Oversee and perform clinical data management activities for any
new
study start up (including protocol review, Case Report Form design, data
entry support, review of data discrepancy criteria, database design
support and User Acceptance Testing
* Ensure standardization of all data management activities,
including
database development/fields, validation checks, SAS reports, SOPs, and
study documentation
* Review, assign, and prioritize all tracking requests and ensure
timely
completion
* Review all change control documentation
* Identify and implement a compliant data management system
* Lead and/or participate in departmental initiatives
* Attend monthly management meetings (on and offsite) and actively

participate in creating and implementing operating plans
* Attend clinical project team meetings and provide data
management support
* Provide monthly status report to upper management
* Participate in continuous (breakthrough) improvement activity
and
process re-engineering projects in support of Stryker Orthopaedics'
continuous improvement initiatives

Email resume in Word to jeffaltman@cisny.com ONLY IF YOU HAVE THE
EXPERIENCE SOUGHT. Please include the job code with the position.

NO RELOCATION. NO VISA TRANSFERS. NO 3RD PARTIES. NO OVERSEAS RESUMES.

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