Clinical Research • Biometrics • Statistics • Programming • Medical Communications
201 - 500
23 hours ago
Clinical Research • Biometrics • Statistics • Programming • Medical Communications
201 - 500
• Quanticate is a leading data-focused Clinical Research Organization (CRO). • Seeking a Lead CDM Programmer to join our team. • Play a critical role in technical and programming requirements of data management. • Work as CDM programmer. • Indicate to the Project Manager any programming resource issues. • Indicate to the project manager any programming timeline issues or potential conflicts. • Assist with technical and programming tasks for allocated projects. • Set up electronic consistency checks when necessary. • Assist with writing and testing of edit checks. • Set up import of electronic data as required. • Prepare electronic data for export. • Report progress against schedules to Project Manager. • Work to the standards appropriate to the study. • Perform quality control checks on programming outputs. • Give opinion on possible improvements to procedures and standards. • Perform other reasonable tasks as requested by management. • Assist with programming tasks for reporting of allocated projects. • Responsible for daily and accurate completion of timesheets.
• Having 5 years of relevant experience in CDM Programming, within the pharmaceutical industry. • Good knowledge in EDC systems programming such as RAVE and/or Medrio and/or Veeve CDMS. • Drafting the CSV documentations , executing the test scripts , building the mock studies and script plans • Building the very complex custom Functions. Custom function expert for Medidata Rave studies – Handle POC role and project management responsibilities • Understand the requirements quickly from customer and implementing the same. • Technical expertise in resolving the prod issues and complex migrations. • Sandbox admin, URL management responsibilities. • Understanding of Clinical Data Management processes. • Good in Investigating and providing a solution. • Resolving and fixing the issues very quickly • Provides flexible support and coverage during migrations , and other study requirements. • Ability to inspire effective teamwork and motivate staff. • Good communication skills (oral and written) and good analytical skills. • Thorough knowledge of ICH Guidelines and GCP including regulatory requirements for the conduct of clinical development programs
• Competitive Salary (Open to discussion based on experience) • Flexible working hours • Holidays (Annual leave, sick leave, casual leave and bank holidays) • Medical Insurance for self and immediate family • Gratuity • Accidental Coverage • Quanticate offers a variety of different learning development opportunities to help you progress (mentoring, coaching, e-learning, job shadowing)
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