Sr Mgr Clinical Research - Centre Head jobs in Navi Mumbai at Teva Pharmaceutical Industries Ltd.

Sr Mgr Clinical Research - Centre Head

Location: Navi Mumbai

Job Description :

Overall responsible for supervising the study related activities.
To provide timely inputs in the protocol and Informed Consent (for e.g. dosing information, contraindications, warnings, precautions, adverse events, and drug interactions) and thus ensure it is scientifically sound and gives a clear detailed description of trial related activities.
To submit protocol and other required study related documents to the Ethics Committee (as per the Ethics Committee SOP and ensure study
commencement only after obtaining IEC and DCGI approval.
Ensure all conditions are fulfilled prior to commencement of the study in case of conditional approval of IEC.
In case of US submission studies, complete form 1572 and 3454 as per SOP CL-G009.
To train and delegate trial related duties to all study personnel prior to start of the study or prior to performing any study specific activity and document the same in ‘Form No.01’.
To ensure adequate facilities and resources are available for proper conduct of the study.
To ensure that the study is conducted as per the EC approved protocol, in-house SOP’s and applicable regulatory requirements.
To inform the volunteer about the study and its procedures, encourage the volunteers to ask
questions and answer their questions in their vernacular language (or with the help of transistor) prior to obtaining their written informed consent.
To ensure timely reporting of the following to all concerned
Deviations /to the protocol
Premature termination of the study.
Serious adverse event in a study.
To provide adequate medical management to the subjects and to review SAE reports.
To ensure proper accountability of investigational product (IP) from the time of receipt till the retention of drugs.
To assess the inclusion/exclusion criteria as per the protocol.
To ensure subject’s fitness prior to dosing and supervise dosing activity of subjects.
To ensure that study samples are transferred to bioanalytical facility with utmost care under required temperature.
To provide the study updates to the sponsor and clinical study report to the Ethics Committee.
To ensure that all trial related documents are attributable, legible, contemporaneous, original and accurate (ALCOA).
To facilitate monitoring / audit / inspection by the regulatory authorities or the sponsor.
To ensure AV recording of study specific informed consent process and checkout.
To ensure that adequate backup of the computerized system data is done and storage media for the audio video recording of Informed Consent process is stored in secured and controlled environment.
To ensure availability and validity of medical insurance and service agreements are in place prior to start of the study.
To report to Centre Head of Clinical unit on all activities.
To perform any other activities as and when assigned by the management.

Qualifications : MBBS + MD

Teva is a global pharmaceutical leader and the world's largest generic medicines producer, committed to improving health and increasing access to quality health solutions worldwide. Our employees are at the core of our success, with colleagues in over 80 countries delivering the world's largest medicine cabinet to 200 million people every day. We offer a uniquely diverse portfolio of products and solutions for patients and we've built a promising pipeline centered around our core therapeutic areas.