Quanticate is a leading data-focused Clinical Research Organization (CRO) that works with pharmaceutical, biotechnology, and medical device companies to provide expert data management, statistical programming, and clinical trial reporting services. We are currently seeking a Lead CDM Programmer to join our team.
As a Lead CDM Programmer at Quanticate you will play a critical role to lead and carry out any required tasks relating to the technical and programming requirements of data management.
· To work as CDM programmer.
· To indicate to the Project Manager any programming resource issues.
· To indicate to the project manager any programming timeline issues or potential conflicts in resource in a timely fashion.
· To assist with all technical and programming tasks for the data management of allocated projects.
· To set up electronic consistency checks when necessary.
· To assist with writing and testing of edit checks.
· To set up import of electronic data as required.
· To prepare electronic data for export and prepare any documentation for return at study completion as requested.
· To report progress against schedules to Project Manager or Lead Clinical Data Manager as appropriate.
· To be aware of and to work to the standards appropriate to the study.
· To perform quality control checks on programming outputs.
· To give opinion on possible improvements to procedures and standards.
· To perform other reasonable tasks as requested by management.
· When necessary to assist as needed with programming tasks for reporting of allocated projects.
· To be responsible and accountable for daily and accurate completion of timesheets.
Requirements
- 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
Benefits
- 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)
Quanticate will never ask for payments as part of the recruitment or hiring process, and all legitimate correspondence from Quanticate will come exclusively from our @quanticate.com domain name. Hiring at Quanticate is based purely on merit and we do not ask or require candidates to deposit any money or complete any paid courses as part of the process. Further guidance on our recruitment process and tips on how to stay safe during your job search can be found on our website at https://www.quanticate.com/careers-guidance.
