Organization : Parexel
Job Role : Software Programmer
Location : Hyderabad
Qualification : BE/B Tech/MCA/M Sc
Experience : Freshers
salary : Best In Industry
No.of Vacancies : NA
Website : www.fresherjobs9.com
Apply Mode : Online
Last Date : ASAP
PAREXEL International is a multinational life sciences consulting firm. It conducts clinical trials on behalf of its pharmaceutical clients to expedite the drug approval process. It is the second largest clinical research organization in the world and has helped develop approximately 95% of the 200 top-selling biopharmaceuticals on the market today. The company publishes the annual PAREXEL R&D Statistical Source book,operates the PAREXEL-Academy,and councils all of the top 50 bio-pharmaceutical and top 30 biotechnology companies.
* Candidate should be BE/B Tech/MCA/M Sc from a recognised university.
* Should have an aggregate of 60% through out academics.
* Should deliver best value and high quality service.
* Must have ability to fill Statistical Programming Coordinator role on projects.
* Should input into and negotiate statistical programming timelines. Ensure that timelines are adhered to.
* Must coordinate and lead a statistical programming team to successful completion of a study within given timelines and budget.
* Should monitor project resourcing, project budgets, and identify changes in scope.
* Must ensure quality control (QC) on all process and technical activities related to derived dataset, table, listing, and figure programming in accordance with corporate quality standards, WSOPs/Guidelines, ICH-GCP and/or other international regulatory requirements are performed.
* Should maintain all supporting documentation for studies in accordance with WSOPs/Guidelines to ensure trace ability and regulatory compliance.
* Must be trained in sponsor WSOP’s and disseminate knowledge to project team members as appropriate.
* Should proactively participate in and/or lead process/quality improvement initiatives.
* Must work closely with the Quality Management Groups (QMG) to ensure compliance with WSOPs/Guidelines, ICH-GCP and any other applicable local and international regulations and participate in internal/external audits and regulatory inspections as required.
* Should 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.
* Must maintain and expand local and international regulatory knowledge within the clinical industry.
* Should assist project teams in the resolution of problems encountered in the conduct of their daily work.
* Should provide a broad range of leadership and influencing capabilities to achieve the business objectives and goals for both PAREXEL and sponsors
* Must provide broad support, including advice on new technologies and industry technical standards (e.g. EDC, CDISC, Statistical principles, CFR Part 11, electronic submissions, applications and communications technologies, etc.) and their integration into Programming processes.
* Should provide leadership, project specific training, stakeholder management, external sponsor support, resource management, and project management for the required programming tasks supporting clinical trial activities.
* Must provide consultancy to internal and external sponsors with regard to statistical programming tasks. In addition, maintain visibility to these sponsors to ensure expectations are being met and that requirements are accurately distributed to the appropriate stakeholders.
* Should provide oversight and guidance on multiple-trial programs, complex trials, and submission projects (including Integrated Summary of Safety or Efficacy).
* Must be able to coordinate project start-up activities, including Unix/PMED project area set-up, creation of global programs (e.g. setup.sas, formats.sas, etc.), tracking spreadsheets, and required documentation.
* Should assist in the production and QC of analysis plans, produce and QC TLF mock-shells, derived dataset specifications, programming specifications, and other process supporting documents.
* Must use efficient programming techniques to produce and/or QC derived datasets tables, figures and data listings.
* Should understand regulatory requirements concerning industry technical standards (e.g. CDISC, 21 CFR Part 11, electronic submissions, etc.) and implications for the department.