PAREXEL International Corporation is a leading global bio/pharmaceutical services organization, providing a broad range of knowledge-based contract research, consulting, and medical communications 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. Perceptive Informatics, Inc., a subsidiary of PAREXEL, provides advanced technology solutions, including medical imaging, to facilitate the clinical development process. Headquartered near Boston, Massachusetts, PAREXEL operates in approximately 70 locations throughout over 50 countries around the world, and has more than 13,000 employees. At PAREXEL, we have a passion for making a profound difference. As an expertise-based business, the caliber of our people and their dedication directly impacts our success, the success of our clients, and the ability to make a difference in the lives of patients worldwide. You’ll be surrounded by supportive leadership and a brilliant team who share a common goal — to improve the lives of millions of patients.
Key Accountabilities • Deliver best value and high quality service. • Ability to fill Database Primary role on projects. The Database Primary will: o Provide input into and negotiate clinical programming timelines. Ensure that timelines are adhered to. o Coordinate and lead a programming team to successful completion of a study within given timelines and budget. o Actively assume activities on a project, as required. o Monitor project resourcing and identify changes in scope. • Interact with Sponsors and Data Operations Leaders as the key contact with regard programming related issues. • Provide technical support and advice to the internal team. • Check own work in an ongoing way to ensure first-time quality. • Ensure quality control (QC) on all process and technical activities related to: o trial set-up and maintenance, and/or o implementation of system applications and upgrades/changes to those applications as required are performed in accordance with corporate quality standards, SOPs/Guidelines/Work Instructions, ICH-GCP and/or other local or international regulatory requirements. • Maintain all supporting documentation for studies in accordance with /Guidelines/Work Instructions to ensure traceability and regulatory compliance. • Proactively participate in and/or lead process/quality improvement initiatives. • Work closely with the Quality Management Groups (QMG) to ensure compliance with SOPs/Guidelines/Work Instructions, ICH-GCP and any other applicable local and international regulations and participate in internal/external audits and regulatory inspections as required. • Develop wider knowledge of areas of Clinical Data Management Systems (CDMS), Electronic Data Capture (EDC), Clinical Trial Management System (CTMS), Safety Reporting, SAS, SQL, and other programming language usage and processes within the GRO, biostatistics, and medical arenas. • Maintain and expand local and international regulatory knowledge within the clinical industry. • Assist project teams in the resolution of problems encountered in the conduct of their daily work. • Provide relevant training and mentorship to staff and project teams. Clinical Systems and Support Programmer • Coordinate system specific project start-up activities. • Lead and supervise and/or configure and implement eClinical applications/systems specifically required in a project including but not limited to Medical Safety Reporting (ISIS), ARGUS, CTMS (IMPACT), PMED. • Lead and supervise and/or execute ongoing maintenance tasks, performance evaluations and tuning of eClinical applications/systems. • Ensure optimum monitoring, support, and maintenance of a reliable, quality, integrated eClinical application/system environment. • Lead and supervise and/or set up / configure automatic reports for studies within the eClinical applications/systems. • Lead and supervise and/or execute automatic import and export of data. • Lead and supervise and/or create, implement and execute procedures to build and maintain database set-up for paper based and/or web based (EDC) clinical data management systems (CDMS) in standard format or CDISC compliant format as required, including the annotation of CRFs where applicable. • Lead and supervise and/or create, implement and maintain consistency checks in standard or CDISC format for database builds in applicable CDMS and EDC, following and understanding internal and external regulatory requirements.. • Lead and supervise and/or create, implement and execute import and export programs, in either standard format, client specific format or CDISC compliant format depending on nature of request. • Perform medium size to complex ad-hoc programming tasks. • Lock/Unlock databases in accordance with guidelines and SOPs. Approve changes made to databases (as required).
Skills • Proficiency in at least one programming environment (e.g., SAS, CDMS, EDC, SQL, VB, Java). • Knowledge of the programming and reporting process within GRO. • Knowledge of SOPs/Guidelines/Work Instructions/System Life Cycle methodologies, ICHGCP and any other applicable local and international regulations such as 21 CFR Part 11 and proven practical application. • Demonstrate ability to learn new systems and function in an evolving technical environment. • Strong leadership ability. • Attention to detail. • Ability to work together with a team (including international teams as required) as well as independently. • Demonstrate strong organizational skills, ability to manage competing priorities, and be flexible to change. • Business/Operational skills that include customer focus, commitment to quality management and problem solving. • Good business awareness/business development skills (including financial awareness). • Ability to create, maintain and define strategies to improve the efficiency of running a clinical trial. • Work effectively in a quality-focused environment. • Demonstrate commitment to refine quality processes. Education • First degree (undergraduate or equivalent) in a relevant discipline is preferred or equivalent work experience. Language Skills • Excellent English written and oral communication skills. Minimum Work Experience • Relevant Clinical Trial industry experience • Experience working with at least one system used within the Clinical Trial process (e.g., SAS, CDMS, EDC (Inform, RAVE, DataLabs), CTMS, Medical Safety Reporting
Subscribe to us
100% Free.
Get It
close
No comments:
Post a Comment