Sr Clinical Data Associate

LOCATION US-NC-Research Triangle Park JOB TYPE Full Time, Employee CATEGORY Biotechnology and Pharmaceutical RELEVANT WORK EXPERIENCE 2+ to 5 Years REFERENCE CODE 08-0104 Stiefel Laboratories is the world's largest privately held pharmaceutical company, committed to dermatology. For over 150 years, in over 100 countries around the world, Stiefel has been known as family-owned and geared towards innovative skin care products. Stiefel is currently headquartered in Coral Gables, Florida and completed the acquisition of Connetics, in January 2007. This strategic combination grew the company's employee base to approximately 4500. This strategic move further strengthened Stiefel's product line as being one of the most diverse within dermatology. The Stiefel's products treat a variety of dermatological ailments that include acne, psoriasis, fungal infections, and hyper-pigmentation. The company's top prescribed products are Duac and Brevoxyl acne medications, and Polytar dandruff shampoo. In addition, there are consumer products that include over-the-counter remedies as fungal infection treatment Zeasorb, Sarna Lotion for itchy and dry skin, and DermaVite dietary supplements. In June of 2007, Stiefel newly launched REVALÉSKIN™. The launch of REVALÉSKIN™ marks Stiefel's entrance into the highly competitive Cosmetic Dermatology market. This new aesthetic line also represents the company's first market entry as a true global brand. For more information, please log onto our company website at www.stiefel.com Sr Clinical Data Associate JOB SUMMARY: The Senior Clinical Data Associate (Senior CDA) will coordinate and manage Data Management activities for Phase I-IV clinical trials in both paper and EDC environments.  The Senior CDA is responsible for the planning, coordination and execution of data management operational tasks for clinical studies performed internally or outsourced to Contract Research Organizations (CRO?s).  They will work in a cross-functional environment.  The successful candidate will demonstrate the ability to establish communication, and proactively identify and resolve issues in planning, resource allocation, and technical areas.  In addition, they will exhibit leadership potential and a working knowledge of regulatory and clinical research standards. ESSENTIAL DUTIES AND RESPONSIBILITIES: ?  Responsibilities include but are not limited to: Review investigative protocols, design/edit CRFs.  Review CRF Completion Guidelines, coordinate database QC and UAT, generate annotated CRFs.  EDC database design and data validation programming (in technologies not requiring extensive programming knowledge).  Create and test data validation specifications.  Perform data validation and discrepancy review. Generation and follow-up on queries.  Perform coding.  Manage SAE, lab and other electronic data reconciliation processes.  Monitor project progress and generate standard metric reports.  Maintain Data Management Plan (DMP), developing guidelines and quality processes to ensure final databases are accurate, complete and consistent.?  Oversight of CRO/Vendor data management activities.?  Collaborate with colleagues in Clinical Operations, Statistics, Statistical Programming, Data Management, Medical Writing, and other areas to gather appropriate requirements and ensure deliverables meet these requirements.?  Participate in the development, implementation, and continuous improvement of SOPs, work instructions, and reporting/data standards.?  Participate in the implementation and continuous improvement of a global clinical data platform.?  Mentor junior clinical data analysts. Requirements: QUALIFICATIONS: ?  Bachelor?s degree in life sciences or related discipline or equivalent work experience?  At lease 3 years Phase I-IV pharmaceutical industry or CRO data management experience?  Previous experience as CDM managing studies from preparation through close-out is preferred?  Previous experience with EDC (electronic data capture) is strongly preferred, including database design and/or data validation programming?  Excellent oral and written communication skills, including the ability to effectively translate between clinical data and clinical research concepts?  Attention to detail and the ability to work efficiently and independently in a deadline driven global environment?  Knowledge of the clinical trial process, clinical protocol requirements, and good clinical practices (GCP)?  Strong technical skills, including the ability to readily adapt to different technologies, platforms, data formats, and systems to meet the requirements of wide-ranging functional areas?  Demonstrated leadership potential?  Demonstrated ability to work in cross-functional teams with a style that builds alliances and emphasizes integrity, results, collegiality and effective teamwork APPLICATIONS SUBMITTED BY RECRUITERS AND STAFFING AGENCIES WILL NOT BE CONSIDERED.  THANK YOU FOR YOUR COOPERATION. Apply Now!