Clinexel, the CRO, is looking for motivated candidates for the following departments- ClinicalOperations, Regulatory, MedicalWriting, and quality assurance, based in Navi Mumbai. We are conducting Phase 1 to Phase IV national and global clinical trials. We work in various therapeutic areas and conduct studies on drugs and medical devices. These are office-based positions.
Candidates with Experience in the following areas are invited:
Regulatory Affairs: handling initial submissions, publishing and transmitting quality submissions to the agency; Publishing major and complex submissions for the US, EU, and Canada. The Associate would be required to perform document-level publishing activities, troubleshoot document issues and perform quality control checks for submission-ready documents per the agency guidance. Associates would collaborate with the medical writing team for planning, preparation, publishing, and quality control checks of submissions.
Clinical Data Management: Experience in CRF Review, CDM-related SOP preparation and review, Preparation of Data Management Plan, Database Development (Designing CRFs, edit checks, Enable-Disable), Database testing (Testing Data Entry screens and Validation Programming), Preparing operations manual and eCRF Filling Guidelines, SAE Reconciliation, Database Lock.
Clinical Operations (CRAs): Site Selection, Site Initiation, site monitoring, and closeout.
QA: Management of QMS, Internal and vendor audit, SOP preparations etc.
Medical Writer: Experience in preparation of protocols, ICF, CSR
Preferred Qualifications: (Pharmacists, BDS, MBBS, Nurses, BHMS/ BAMS, physiotherapists, MSc. Life Sciences).
Immediate joiners will be preferred
Application process; If you are interested, please share your cv at firstname.lastname@example.org