Title:  Principal Investigator

JOB DESCRIPTION

Job Location:  Bangalore
Department: Human Pharmacology Unit

About Syngene
Syngene International Ltd. (BSE: 539268, NSE: SYNGENE, ISIN: INE398R01022), is an integrated research, development and manufacturing services company serving the global pharmaceutical, biotechnology, nutrition, animal health, consumer goods and specialty chemical sectors. Syngene’s 4500+ scientists offer both skills and the capacity to deliver great science, robust data management and IP security and quality manufacturing, at speed, to improve time-to-market and lower the cost of innovation. With a combination of dedicated research facilities for Amgen, Baxter, Bristol-Myers Squibb and Herbalife, as well as 1.9 Mn sq ft of specialist discovery, development and manufacturing facilities, Syngene works with biotech companies pursuing leading edge science as well as multinationals including GSK and Merck KGaA.

Key Responsibilities:

• To assure that the rights and welfare of the research subjects are guaranteed, correctly and obtaining the signature of the informed consent form.
• Supervise or personally conduct the research in compliance with Good Clinical Practice and to the ethical principles that have their origin in the declaration of Helsinki and as per protocol and applicable regulatory requirement.
• Assure that all study subjects have been informed of their obligations pursuant to the research protocol.
• Provide resources, staff and facilities including instruments and equipment required for the timely conduct and conclusion of the study.
• Have a thorough Knowledge of the Investigational medicinal product, protocol and the contents of the investigator’s brochure.
• Evaluation of the adverse events and their effective management.
• Be aware of medical decisions and adverse event treatment.
• Comply with the study protocol. Signature of the agreement and of the protocol;
• Responsible for Supervision of Trial Master file with the required documents maintenance by designated in charges.
• Responsible to provide protocol training and other study related update/information to staff involved in the conduct of a study.
• Facilitate the access of documents to the monitor and/or for audits/ inspections. To assign responsibilities for the designees, or to authorize the conduct of study phases in third centers.  The authorization should be formally documented and submitted to the competent agencies, and approved as appropriate.
• Will be responsible for withdrawing a study subject in circumstances as described in the study protocol or if such action appears in the subject’s best interest.
• To co-ordinate for the approval by Ethics Committee and the necessary reviews.
• Provide Interim and final reports to Ethics Committee, as per the regulatory requirements.
• Update Sponsor, Ethics Committee and regulatory authorities as and when required and as applicable.
• Identifying training needs and assuring that each individual performing activity receives regular training
• Responsible for periodic review of SOPs/IOPs.
• Responsible for investigational product accountability.
• Responsible to follow the study randomization procedures, if any, and should ensure that the code is broken only in accordance with the protocol.
• Review and approval of the Clinical Study Report.
• Liaison with Quality Assurance Department for external sponsor audits, internal audits or any other regulatory inspection. 
• Ensure Attributable, legible, contemporaneous, original and accurate data reported to the sponsor in the CRFs and in all required documents.
• To carry out any other responsibility as and when assigned by the Head-Human Pharmacology Unit / Head of Syngene Clinical Development Team.

Equal Opportunity Employer:
It is the policy of Syngene to provide equal employment opportunity (EEO) to all persons regardless of age, color, national origin, citizenship status, physical or mental disability, race, religion, creed, gender, sex, sexual orientation, gender identity and/or expression, genetic information, marital status, status with regard to public assistance, veteran status, or any other characteristic protected by applicable legislation or local law. In addition, Syngene will provide reasonable accommodations for qualified individuals with disabilities.