About This Role
Medical writing is at the core of this role, which involves designing clinical study protocols, reports, and other essential documents. The position is responsible for ensuring compliance with regulatory requirements and supporting the execution of personal healthcare clinical trials.
Responsibilities
- Design Clinical study Protocols, Standard Operating Procedures (SOPs), Clinical Study Reports, Case Report forms, Informed Consent documents/assent forms, working policies, Pre-study meeting presentations, Training Manuals, Study Synopsis, protocol appendices, and any other documents according to project needs and per regulatory requirements
- Design Personal Healthcare Training Manuals per instructions of Head of the Department
- Conduct project tracking meetings of PHC with other stakeholders
- Hard bind final CSR and submit to sponsor
- Final package CD/DVD of raw data submission to sponsor
- Coordinate, submit, and obtain approval from the EC in consultation with Head of Department/Site Manager
- Archive completed projects
- Develop and review SOPs pertaining to operations of the unit, clinical conduct of the studies and bio-instruments
- Assist to perform trial related activities such as application, removal, dosing supervision, instrument operation, subjective perception from subjects, or any other assigned activities
- Collaborate on inter-departmental/Sponsor communications and other trial related activities such as training to study team
- Assist Investigator and Head of Department/Site Manager for planning and execution of personal healthcare clinical trials in compliance with all standard operating procedures, other systems of Karmic Lifesciences LLP and applicable regulations
- Aid PHC team to ensure strict adherence to protocol, patient/subject compliance, ICH-GCP procedures, SOPs and applicable regulatory guidelines
- Perform or supervise the conduct of study-related procedures
- Manage and motivate the investigational staff and other disciplines involved and take measures to minimize any potential risks
- Responsible for study closeout & follow up activities in order to maintain documents at the site
- Ensure to follow and adherence of organization's general rules and applicable policies
- Perform any additional responsibilities given by Head of the Department / Management
Requirements
- 1 to 5 years of experience
- M.Sc, B.Pharma, M. Pharma qualification
- Medical Writing
- Good Clinical Practice
- Clinical Protocol
- Clinical Study Report
- Clinical Study Design
About the Company
Karmic Lifesciences LLP is involved in clinical trials.