Sr. Principal Investigator (Head Clinical Operations)

Job Description

#hiring 'Sr. Principal Investigator (Head Clinical Operations)' for one of the reputed Organization into Lifesciences & clincial research industry Position Title: 'Sr. Principal Investigator (Head Clinical Operations) Education Qualification: MBBS/MD Pharmacology Experience: 15+ years Responsibilities:- Responsible for the end-to-end conduct of Clinical studies in accordance with Good Clinical Practices (GCP), Protocol & SOPs. Responsible to lead entire clinical operations as 'Sr. PI/ Head Clinical' Responsible for Clinical TAT, Quality, staff attrition rate and staff training. System upgradation and E-CRF implementation Regulatory and sponsor audit handling. Responsible for delivering full scope BA/BE, Biosimilar research studies. To co-ordinate the progress of study activities within various team components such as Principal Investigators, Medical Investigators, Screening coordinator's, CRA's, Pharmacists, Paramedical, Medical Writing, QC, & Finance. To assess & provide clinical feasibility of BE study To co-ordinate with PM & BD team to achieve completion of various tasks related to study in the agreed timelines. To ensure that the clinical staff are meeting with defined workload & maintaining quality through regular review. Responsible for the review of study Protocol, ICF, CRF. Responsible for the review of Clinical Study Report. To communicate & co-ordinate with Sponsors as and when required. To co-ordinate with Independent Ethics Committee as and when required. To review departmental SOPs for necessary revisions as and when required. Focus will be on the overall improvement & strengthening of system & processes. Responsible for the appropriate planning & scheduling of BE studies. Responsible to ensure the availability of sufficient eligible volunteers for the conduct of the study. Responsible to plan screening activity of volunteers as per protocol requirement. To Impart protocol training & to assign duty delegation to study personnels based on their qualification, experience, expertise & job responsibility. Identifying, recording, reporting & management of AE's & SAE's that may occur during the conduct of study. Monitoring the conduct of study for appropriate quality compliance & for timelines during various stages. To evaluate eligibility of volunteers as per Inclusion/Exclusion criteria. Appropriate selection of external vendors which plays vital role in the conduct of the study. To provide training to the clinical staff /study personnels as and when required to improve overall conduct of the study. Responsible for the management of clinical staff in accordance with organization's policies & applicable regulations. Responsibilities include planning, assigning & directing the tasks, appraising performance && guiding them for professional development If Interested than kindly share CV to: recruit.corp12@apexservices.in