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Job Qulification: Experience: Minimum Required: • Minimum four years of relevant work experience to include data management, database support and dictionary support activities including two years experience working in Oracle Clinical applications • Demonstrate good problem solving skills and a proactive approach • Good oral and written communication skills • Basic knowledge of clinical trial process and data management, biometrics, and systems applications to support operations • Demonstrated ability to work in a team environment • Demonstrated ability to work independently under supervision • Proven interpersonal skills. Education/Qualifications/Certifications and Licenses Minimum Required: • University/college degree (life science, computer science, programming, pharmacy or related subject preferred), or certification in a related profession from an appropriately accredited institution (e.g., nursing certification, computer science, medical or laboratory technology) • Knowledge of drug development process and knowledge of the Oracle Clinical Data Management System • Basic knowledge of SAS, SQL, SQL-Plus, PL/SQL, Visual Basic and relational databases • Knowledge of Oracle Clinical practices and procedures • Knowledge of OCR and Imaging systems • Fluent in English, both written and verbal Competencies: Required: • Core Competencies: Focus- on Customers Innovate- and Change Pursue- Scientific and Process Excellence Work- with Others Achieve- Results Job Title 9 : Statistical Programmer£¨10¸ö£© Job Description: Interact with project team members in related disciplines e.g. Clinical Data Management, Clinical and Biostatistics. • Prioritize personal workload to meet specified completion dates. • Display a positive attitude at all times, promoting and contributing to a good team spirit with a productive and professional environment. • Develop good problem solving skills and a willingness to learn and seek advice from senior Statistical Programming staff. • Acquire knowledge of other aspects of the work of a Statistical Programmer Analyst under the supervision of the senior Statistical Programming staff. • Perform other duties as assigned by senior Statistical Programming staff. • Carry out all activities according to Covance SOPs working within the framework of the Quality Management System and to Good Clinical Practice (GCP). • Develop and review SAS programs and output as required for the management of clinical trial data, the tabulation of data, preparation of patient data listings, graphical output, creation of derived datasets and statistical analysis of data as specified in the Statistical or Report Analysis Plans. • Develop programs for ad hoc tables and listings. Write, modify, and maintain programs that produce diagnostics and listing for data review in support of Data Management. • Carry out electronic data transfer (both incoming and outgoing. Develop programs for data transfers and assist in their review to ensure the data transfer has been produced to specification. • Set-up utilities/SAS based systems to assist and facilitate Clinical Data Management activities. • Review draft and final production runs for projects to ensure quality and consistency. Job Qulification: Required: BSc in a computing, life science, mathematical or Statistical subject. A high computing content is considered to be beneficial, however proven computing skills are most important. Alternative academic qualifications or experience are assessed to ensure equivalent background. Some knowledge of SAS and the fundamental principles of programming and program development. Some understanding of the clinical trial process, Data Management and programming activities Good organizational skills and the ability to prioritize own work. Self motivation. Good time management skills and the ability to work to tight deadlines whilst maintaining the highest standards of work. Effective communication skills. A co-operative and team orientated approach. Some general business awareness and an appreciation of the business needs of a CRO. Job Title 10: Clinical Data Manager £¨3¸ö£© Job Summary: Data management leadership on a large/global project,or multiple projects with responsibility for the development of the project Data Management Plan;data management systems set up;and data accession,data entry and data review specifications and processes;and oversight of data management activities for the delivery of clinical data according to client quality and integrity specifications, and project timelines and budgets. -Develop and maintain a close liaison with project client contacts, core team members,and Project Managers to drive the data management aspects of project delivery. Job Qualification: Minimum 5 years relevant work experience in data management with approximately 1 year technical supervisory experience to include data management, clinical operations, and knowledge of several therapeutic areas. Demonstrated skill for technical management of staff exceeding 5 employees. financial management of gross revenues in excess of $250K per year Excellent oral and written communication and data management,clinical,operations,biometrics,quality management, and sustems applications to support operations Working knowledge of the relationgship and regulatory obligation of the CRO industry with pharmaceutical/biotechnological companies. Ability to lead by example teams on project strategies and achievement of department goals,objectivities,and initiatives and to encourage team members to seek solutions Demonstrated managerial and interpersonal skills. University/college degree (life science, computer science, programming, pharmacy or related subject preferred), or certification in a related profession from an appropriately accredited institution (e.g., nursing certification, computer science, medical or laboratory technology) Additional relevant work experience will be considered in lieu of formal qualifications Broad knowledge of drug development process Understanding of global clinicaldevelopment budgets and relationship to productivity targets Knowledge of effective clinical data managerment practices Knowledge of time and cost estimate development and pricing strategies Thorough knowledge ofICH Guidelinesand GCP including international regulatory requirements for the conduct of clinical development programs, especially as related to data handling and processing |
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