Clinical Programmer Analyst

Job Category: Biotech/R&D/Science Career Level: Experienced (Non-Manager) Location: Waltham, MA 02451           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 PAREXEL is looking for Clinical Programmer Analysts for their Waltham, MA or Durham, NC offices. The Clinical Programmer Analyst will be responsible for providing technical expertise and resource for the conduct of clinical trials and supporting activities related to clinical systems. General areas of responsibility include: database development for EDC and CDMS; data consistency check programming; import/export programming; CDISC database build/exports/imports; ad-hoc programming; and ongoing support. Perform responsibilities in accordance to corporate quality standards, WSOPs/Guidelines, ICH-GCP and/or other international regulatory requirements. Key Accountabilities ' Deliver best value and high quality service for the benefit of the Clinical Data Manager through the application of technical programs or database implementation. ' Support Quality Management efforts through the production and maintenance of technical supporting documentation and ensure that documentation is compliant with corporate quality standards, SOPs/Guidelines, appropriate regulations and Computer System Validation (CSV) requirements. ' Maintain all supporting documentation in accordance with WSOPs/Guidelines to ensure traceability and regulatory compliance. Document any deviations and disseminate to the rest of the group. ' Provide local or global support/mentoring to Data Management on technical activities. ' Create, implement and execute import and export programs, in either standard format, client specific format or CDISC compliant format depending on nature of request. ' Participate in the rollout of Process and Systems as part of the project implementation teams, when required. ' Participate in internal/external audits and regulatory inspections as required. ' Work closely with the Quality Management Groups (QMG) to ensure compliance with SOPs/Guidelines, ICH-GCP and any other applicable local and international regulations. ' Works closely with IS, QMG and other DM operations staff to ensure continuous process improvement. ' Provide relevant training for staff and project teams to assist them in resolution of problems encountered in the conduct of their daily work or on application of Clinical Systems. ' Provide input into other Technical Operations Group activities as required or reasonably requested. ' Develop, improve and implement project specific tools, including, but not limited to standard project directories and subdirectories, document file names and status reports that result in improved efficiencies. ' Maintain technical documentation - parts that are applicable to the Technical Operation Group. ' Approve and perform QC, from a technical perspective, the electronic data receipt, conversion, database build, electronic and paper specifications, and load programs to be released for production use on live data. ' Perform quality control on all technical activities related to trial set-up and processing in accordance with corporate quality standards, WSOPs/Guidelines, ICH-GCP and/or other international regulatory requirements. ' Create, implement and execute procedures to build and maintain database set-up for CDMS or EDC in standard format or CDISC compliant format, depending on request. To include the annotation of CRF's where applicable. ' Set-up, test and approve existing relevant tools, to ensure that this has been documented in the standard QC checklist and ensure process compliant to the use of the tool. ' At all times, utilize tools built to support the technical processes, e.g. Change-Control database. ' Ability to run projects as a Technical Lead. This involves creating and negotiating timelines for projects and ensuring that timelines set for projects are met, adhered to and responsible for communication made to Project Management and Client (if necessary) ' Lock/Unlock database in accordance to guidelines and WSOPs and approve changes made to database. ' Create standards, either through toolsets, libraries or processes, as required for Data Management to ensure efficient, effective and optimal process. ' Develop wider knowledge areas of CDMS, EDC, SAS, other programming language usage and process within the data management arena. ' Maintain and expand local and international regulatory knowledge within the clinical industry. ' To lead, supervise, mentor and provide technical expertise and guidance to create, maintain, QC and implement consistency checks in standard and CDISC format for database builds in CDMS and EDC, following, understanding and enforcing internal and external regulatory requirements within the dept and with clients. ' To provide and supervise technical ad-hoc programming and specification to the Data Management department and client. ' To derive and QC advanced programming, other processing documents, and client proposals documents. ' To lead and provide work direction to junior member of staff to timelines and regulatory compliance ' Create, QC, standard macros and applications to improve the efficiency of the department ' Perform validation of computer systems utilized by the Data Management department ' Review of Case Report Form (CRF) design ' Development or review of Data Validation Specification (DVS) ' Mentoring of Clinical Programmers and Clinical Programmer Analysts Education: M.Sc/B.S./B.Sc./B.A. in a science or industry-related discipline ' Relevant work experience recommended ' Project Management or Management experience recommended. 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=2198452&boardid=749