Job Description
The ideal candidate will be responsible for execution of various clinical studies at the site.
Responsibilities
Budgeting and Procurement
• To plan and prepare the site-specific annual budget for conducting various clinical study and appropriate resource availability
• To ensure timely procurement or availability of various resources required for clinical operations
• To monitor and Review site specific expenditures against the budget
Study Planning & Preparedness
• To responsible for preparation of study slot for execution of various clinical studies at the site.
• To monitor and ensure that the required number of suitable subjects is recruited within the agreed recruitment period.
• To ensure sufficient time is allocated to properly conduct and complete the study within the agreed study period.
• To ensure availability of adequate number of qualified staff and adequate resources for conduction of the study as per protocol
• To responsible for ensuring the safety of subjects while conducting various studies.
• To ensure overall execution of the study as per laid protocols and no deviation.
• To co-ordinate with the clinical research personnel for planning of specific study schedule.
Communication with IEC
• To obtain written and dated approval from the IEC for the study protocol, informed consent form, and any other written information to be provided to subjects.
• To ensure to incorporate the suggestion given by IEC members in respective documents and take re-approval in case of any changes.
• Should provide the IEC with a current copy of the Investigator's Brochure. If the Investigator's Brochure is updated during the study, the copy of the updated Investigator’s Brochure should be provided.
• To ensure to keep informed the Sponsor, IEC and applicable regulatory authorities for any amendment regarding the Protocol, ICF and safety related information or Clinical updates.,
• To ensure that the study is conducted in compliance with the protocol agreed by the sponsor and, if required, by the regulatory authority and which was given approval by the IEC.
• To ensure that no deviation from, or changes in the protocol is made without agreement by the sponsor and prior review and documented approval/favorable opinion from the IEC, except where necessary to eliminate an immediate hazard to study subjects, or when the change involves only logistical or administrative aspects of the study.
• To ensure review and proper documentation of any deviation from the approved protocol
• To monitor the study and ensure that the study is conducted as per approved Protocol, International Conference on Harmonization-Good Clinical Practice (ICH-GCP), and applicable regulatory and in house Standard Operating Procedures (SOP).
• To ensure proper review and response to QA findings and compliance check procedure within timeline.
• To responsible to represent departmental audits conducted by sponsors or any study related regulatory auditors.
Qualifications
• MD Pharmacology with 8-13 years of experience
• Experience in working with CROs
• Leader to handle a team of 50-100 team members
Responsibilities
Budgeting and Procurement
• To plan and prepare the site-specific annual budget for conducting various clinical study and appropriate resource availability
• To ensure timely procurement or availability of various resources required for clinical operations
• To monitor and Review site specific expenditures against the budget
Study Planning & Preparedness
• To responsible for preparation of study slot for execution of various clinical studies at the site.
• To monitor and ensure that the required number of suitable subjects is recruited within the agreed recruitment period.
• To ensure sufficient time is allocated to properly conduct and complete the study within the agreed study period.
• To ensure availability of adequate number of qualified staff and adequate resources for conduction of the study as per protocol
• To responsible for ensuring the safety of subjects while conducting various studies.
• To ensure overall execution of the study as per laid protocols and no deviation.
• To co-ordinate with the clinical research personnel for planning of specific study schedule.
Communication with IEC
• To obtain written and dated approval from the IEC for the study protocol, informed consent form, and any other written information to be provided to subjects.
• To ensure to incorporate the suggestion given by IEC members in respective documents and take re-approval in case of any changes.
• Should provide the IEC with a current copy of the Investigator's Brochure. If the Investigator's Brochure is updated during the study, the copy of the updated Investigator’s Brochure should be provided.
• To ensure to keep informed the Sponsor, IEC and applicable regulatory authorities for any amendment regarding the Protocol, ICF and safety related information or Clinical updates.,
• To ensure that the study is conducted in compliance with the protocol agreed by the sponsor and, if required, by the regulatory authority and which was given approval by the IEC.
• To ensure that no deviation from, or changes in the protocol is made without agreement by the sponsor and prior review and documented approval/favorable opinion from the IEC, except where necessary to eliminate an immediate hazard to study subjects, or when the change involves only logistical or administrative aspects of the study.
• To ensure review and proper documentation of any deviation from the approved protocol
• To monitor the study and ensure that the study is conducted as per approved Protocol, International Conference on Harmonization-Good Clinical Practice (ICH-GCP), and applicable regulatory and in house Standard Operating Procedures (SOP).
• To ensure proper review and response to QA findings and compliance check procedure within timeline.
• To responsible to represent departmental audits conducted by sponsors or any study related regulatory auditors.
Qualifications
• MD Pharmacology with 8-13 years of experience
• Experience in working with CROs
• Leader to handle a team of 50-100 team members
💡 Quick Summary
Seeking a career-building opportunity? The Head position is now open for candidates interested in the Operations Executive Jobs sector. This role in Ahmedabad offers a professional environment and growth potential.
Requirement Snapshot: Candidates should possess basic communication skills, a proactive attitude, and the ability to work in a team. Experience in Operations Executive Jobs is a plus.