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Clinical Data Manager III Job
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| Employer Name: BiotechCrossing |
SpiderID: 2298665 |
| Location: Durham, North Carolina |
Date Posted: 6/20/2008 |
| Wage: |
Category: Biotech |
| Job Code: 5536524 |
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Job Description:
The Clinical Data Manager (CDM) will coordinate and manage Data Management services for Phase I-IV clinical trials across multiple therapeutic areas in both paper and EDC environments. Responsibilities include project planning and initiation, study set-up, ongoing processing and database lock. The successful candidate will be a team player with a client service mentality that works and communicates well within a highly matrixed cross-functional project team environment. Responsibilities include but are not limited to: Represent company at Bid Defenses, Sponsor Kick-offs, and Investigator Meetings. Review investigative protocols, review/Edit CRFs and mock eCRFs. Design CRF Completion Guidelines, coordinate database QC and UAT. Create and test Data Validation Specifications. Perform data validation and discrepancy review. Generate and integrate queries. Perform coding. Manage SAE, lab and other electronic data reconciliation processes. Monitor project progress and generate standard metric reports. Participate in internal and client team meetings. Demonstrate knowledge of industry standards and compliance with Good Clinical Practice (GCP), ICH, 21CFR and other regulatory requirements. Adhere to quality, timeline and productivity requirements. Propose new approaches, methods or technologies to gain efficiencies and exceed client expectations. Experience: Degree in life sciences, nursing, allied health or equivalent experience. Two or more years in clinical trial Data Management or equivalent experience. Technical proficiency in one or more of the following clinical data management systems: Oracle Clinical (OC), ClinTrial (CT4) or Phase Forward's InForm. Attention to detail, strong organizational and project/time management skills. Ability to solve problems by using a logical, systematic, sequential approach. Excellent interpersonal, verbal and written communication skills. Ability to manage multiple conflicting priorities and varied concurrent tasks.
For more information, please click here To visit us at BiotechCrossing.
For further information, please visit us online at http://www.biotechcrossing.com
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Job Criteria:
Start Date:
Position Type: Full-Time Permanent
Years of Experience Required:
Education Required:
Overnight Travel:
Vacation Time:
Contact Information:
| Contact Name: - |
Company Type: Employer |
| Company: BiotechCrossing |
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| City: Pasadena |
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| State: California |
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| Zip: 91101 |
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Web Site: http://www.biotechcrossing.com
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