Director, Clinical Programming
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Company: SHS, Inc.
Contact Name: Tim Jadwin
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- Job ID:3781
- Date:06/27/2008
- Location:California
- State:California
- Degree:Unspecified
- Current Professional Level:Sr. Director/Director
- Additional Salary/Compensation:
- Commensurate on experience.
- Job Types:
-
CLINICAL AFFAIRS, RESEARCH & DEVELOPMENT (Drug)
Job Description
Company Summary: Our client is a technology-driven, global health care company that develops and commercializes specialty pharmaceutical products for the eye care, neuromuscular, skin care and other specialty pharmaceutical products.
The Opportunity
You will drive our client's global Clinical Programming operations. Provide technical guidance and strategic direction to clinical programming activities worldwide. Technical oversight and management leadership of the Clinical Programming group and its activities. Influence related areas to identify, implement and validate systems used in Clinical Research both internally and at Contract Research Organizations and other service providers. Oversee the implementation of electronic systems implemented internally or through external vendors according to current regulatory requirements.
Responsibilities:
- Degree and experience in Computer Science, Statistics, Life Sciences or related field. 10 years of pharmaceutical experience with a Bachelors degree or equivalent. 8 years of pharmaceutical experience with a Masters degree or equivalent. 6 years of pharmaceutical experience with a Ph.D. degree or equivalent.
- 5 to 6 years of a leadership role in a Clinical Information Technology and Programming environment. Responsible position in a multi project environment with timeline and budgetary responsibilities.
- 2 to 3 years of a leadership role in organizing programming activities to support Clinical Data Management activities.
- Experience in a medium or large pharmaceutical or contract research organization company.
- Experience in the support and project management of global clinical trials.
- Leadership on the definition, implementation and maintenance of electronic systems used in clinical studies (electronic data capture, trial management, document management, and project management systems).
- Direct management responsibility of technical personnel of varying levels of experience. Indirect management responsibility of technical and non-technical personnel.
- Excellent knowledge of Clinical Data Management Systems (preferably Oracle Clinical), Clinical trial methodologies as well as current and emerging global data management technology standards.
- Knowledge and understanding of Regulatory Guidelines for the use of computer systems in clinical studies.
- Demonstrated technical leadership abilities and skills in analysis, design, specification and programming of computer systems. Demonstrated problem solving and technical skills.
- Demonstrated management skills with excellent written and interpersonal communication skills. Demonstrated ability to lead and work on a multi disciplinary team with multiple priorities.
- Ability to travel 5 to 15 percent.
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