- Supporting the Clinical Operations Manager and Medical team in planning and execution of Post Marketing studies
- This will involve working with the Medical Team and CRO on digitizing protocol, CRF, Agreements, Informed Consent form, initiating study in coordination with CRO, Tracking of study through dashboard, Support in identifying and managing bottlenecks
- Has to ensure adherence to time lines
- Will have to support Clinical Operations Manager and Medical Team on progress at defined intervals
- To ensure all programs are in Line with GCP and Local Regulatory Guidelines
Deliverables:
- Review of project documents received from Medical Manager.
- Preparation of project plans and timelines for approval by supervisor
- Digitalization of documents by CRO
- Oversee Study Initiation
- Tracking study progress
- Oversee study close out.
- Track Data management, and CSR writing.
Reporting:
- Weekly and Monthly reports on Study Progress Clinical Operations Head
Compliance and Audit Preparedness
- Conduct studies as per GCP and local DCGI regulations.
Stakeholders
- Medical Function, Marketing team, External Vendors, CROs, Finance team
Qualifications:
- M Pharm/ MSc Life Sciences / MSc Clinical Research/ Pharm D
- Fresher or 1-year experience in a related area.
- Should demonstrate aptitude for working in the specific area of Post Marketing Studies.
- Knowledge of certain aspects of Clinical research process will be preferred.
- Ability to interact with multiple internal and external stakeholders
