Medical Monitor

Hi Candidate,

Looking for MBBS/MD Pharmacology candidate for Medical monitor profile with 1+ years experience in Clinical Trial (Preferred PK Studies)

Role & responsibilities

Review applicable clinical trial related documents.
Conduct medical review of the Concept Sheets to evaluate the study indication, study design, study procedure, Inclusion Exclusion criteria.
Provide inputs for the study from clinical perspective. Conduct review of the Clinical Study Protocols, Informed Consent Form, Investigators Brochure, and Case report form of a clinical trial from clinical perspective.
To attend and participate in SEC Meetings.
To review and approve Safety Medical Monitoring Plan.
Conduct training for the clinical trial team focused on the disease, drug, study design and procedures.
» Eligibility confirmation of all potential patients after review of Inclusion Exclusion criteria, Lab reports, Real Medical records, Call with PI etc.
» Responsible for medical query resolution of the study team (CRA, PM, QA Sponsor, Site etc.)
» Participate in the review and reporting of Lab reports, AE/SAE.
» Conduct a medical review of the Tables, Figures and Listings, and the integrated Clinical Study Reports as appropriate.
» Participate in both internal and external project team meetings and liaising directly with customers, as required.
» Revisions of SOPs, preparation of training documents.
» Any other task assigned by HOD/Designee

Preferred candidate profile

MD Pharmacology

Perks and benefits

As per industry Slandered