Clinical Quality Control Specialist
Location: Navi Mumbai, IN, 400706
Job Description :
- Retrospective review of study documents to ensure adherence to required SOPs and regulatory requirements.
- Ensuring quality by reviewing all study related documents like Regulatory binder, Raw data binders, Case Report Form binders, Study close out report, Sample Case record form, Study updates, screening examination
- Monitoring of SAE and AE management and reporting to all applicable bodies (Regulatory, Ethics committee, Sponsor and PVPI team.)
- Ensuring compliance of standard operating procedures, regulatory guidelines and all applicable laws
- Review of SDTM & Clinic tables data with the source document.
- Quality Control of study activities such as IP dosing, sample collection, sample separation, sample segregation, verification and sample transfer for all clinical studies
- Plan and conduct general in-house audits of facility areas like pharmacy, screening, clinic ward, ICU
- Ensure that the processes needed for Quality management system are established, implemented and maintained.
- To verify the calibration and verification of instruments/equipment.
- To coordinate with the user department and medical writing department for clinical study reports.
- Quality Review of protocol & Informed consent forms by referring the available literature for the drug molecule.
Qualifications : BSc / Msc Clinical Research, 2yrs Relevant Experience.