Principal Investigator

Principal Investigator for early phase trials Review of RFX and feasibility Provide crucial insights and anticipate risks and provide solutions Co-ordinate with PMO Bio-analytical Statistical Finance Regulatory Central Lab Legal and Administration departments for development and execution of the projects 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 Review Quality metrics- audit finding indices power BI data analysis and propose action plans for continuous improvement Reduce redundancy and work towards Operational Excellence Developing and cascading the organizations strategy mission statement to the lower ranking staff and implementing appropriate rewards recognition and coaching corrective practices to align personnel with company goals TECHNICAL FUNCTIONAL SKILL Sound understanding of GCP and regulatory requirements Effective communication skills both written and verbal BEHAVIORAL MANAGERIAL SKILLS Commitment to Syngene core values - Excellence Professionalism Integrity Good Interpersonal skills Team Time management Relationship management - Internal External Positive attitude Customer Centric Result oriented Proactive Continuous improvement Ready to accept any new challenges Learnings Commitment to safety demonstrated by adhering to following behaviors Overall adherence to safe practices and procedures of oneself and the teams aligned Contributing to development of procedures practices and systems that ensures safe operations and compliance to company s integrity quality standards