Clinical Data Manager II

Job Category: Biotech/R&D/Science Career Level: Experienced (Non-Manager) Location: Durham, NC 27713           Job Description: PAREXEL International Corporation is a leading global bio/pharmaceutical services organization, providing a broad range of knowledge-based contract research, medical marketing and consulting services to the worldwide pharmaceutical, biotechnology and medical device industries. Committed to providing solutions that expedite time-to-market and peak-market penetration, PAREXEL has developed significant expertise across the development and commercialization continuum, from drug development and regulatory consulting to clinical pharmacology, clinical trials management, medical education and reimbursement. Headquartered near Boston, Massachusetts, PAREXEL operates in 55 locations throughout 43 countries around the world, and has over 6,315 employees. For more information about PAREXEL International visit www.PAREXEL.com 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 PAREXEL 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. 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. RESPOND HERE! Respond immediately by accessing the following dedicated online response form which will allow you to cut and paste your resume. This form will go directly and immediately to the hiring authority for this position. Access the online response form at: http://sh.webhire.com/servlet/resp/rf?jobid=2165036&boardid=749