Clinical Programming Manager Needed

Smith Hanley has an immediate opening for a Manager, Clinical Programmer contractor with the opportunity to convert to a permanent employee within 4-6 months for the appropriate candidate.  PRINCIPAL ACTIVITIES " Manage personnel, priorities and workload within the Clinical Programming group. " Independently handle highly complex projects and solve problems for clinical trial data entered in-house and remotely to ensure complete, accurate, high quality, regulatory compliant data for publications and regulatory submissions. " Manage Clinical Programming personnel on activities that include: " Develop, validate, and execute SAS code to create edit specifications, data listings, databases, and various clinical reports. " Import/export clinical databases across a variety of applications to/from SAS and ensuring CFR 21 Part 11 compliance.  Lock and archive databases. " Design and develop SAS clinical databases according to company standards and CDISC version3.1.1; annotate case report forms and develop database documentation. " Perform SAS system maintenance that includes software upgrades, updates, installs, change controls, and qualifications; monitor SAS performance. " Develop, test, implement, document, and maintain in-house clinical data management systems. " Develop and maintain standard SAS format libraries, macro libraries, and common program libraries. " Develop, validate, and maintain centralized clinical data repository of all clinical trial data. " Provide training and development to Clinical Programming personnel; prepare and conduct performance reviews. " Manage CROs, external vendors, and project teams. " Identify, create, and finalize clinical programming SOPs. " Evaluate and implement new technologies. " Perform other activities as required. REQUIREMENTS AND ACCOUNTABILITY " Requires a Bachelors degree with over 10 years of clinical programming experience or a Masters degree with 8-10 years of clinical programming experience or equivalent work experience.  The degree must be in a computer science or related discipline.  " Requires a minimum of 5 years of management experience in the clinical programming field. " Requires 5-8 years SAS programming experience that includes Base SAS and SAS/Macro, and program validation experience.  SAS/AF, Access, and Connect experience a plus. " Possess previous management experience; training and development of personnel; and preparation and conducting performance reviews. " Possess a thorough knowledge of medical terminology, clinical protocols, processing clinical data, and the regulatory submission process. " Possess a strong knowledge of clinical database structure, coding dictionaries, and CDISC version 3.1.1. " Experience importing/exporting and merging clinical databases across a variety of applications. " Proficient on regulatory requirements for clinical programming and experience in identifying, creating, and finalizing SOPs. " Proficient on standardization, design, documentation, and validation of clinical programs, databases, and systems. " Proficient with an electronic data capture (EDC) system and/or a pharmaceutical industry data management system.  If you would like to be considered for this opportunity, please forward your resume to the email address provided below. If you meet the minimum requirements someone will be in touch with you to discuss the specific details. Education Level: Bachelor's Degree Job RefCode: 3022482 Email: Apply by Email