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Job Location Bangalore Department Clinical Operations About Syngene Incorporated in 1993 Syngene International Ltd is an innovation-focused global discovery development and manufacturing organization providing integrated scientific services to the pharmaceutical biotechnology nutrition animal health consumer goods and specialty chemical industries around the world Syngene s clientele includes world leaders such as Bristol-Myers Squibb Baxter Amgen GSK Merck KGaA and Herbalife Its innovative culture is driven by the passion of its 4240- strong team of scientists who work with clients from around the world to solve their scientific problems improve R D productivity speed up time to market and lower the cost of innovation Job Purpose 1-2 Lines CRA to liaise with site and monitor all Cliniops Studies as assigned Key Responsibilities Maximum 5-8 Points Perform site selection initiation monitoring and close-out visits in accordance with contracted scope of work Standard Operating Procedures and all the applicable Good Clinical Practice GCP Guidelines and Regulations Responsible for site management for the assigned protocols sites and therapeutic areas Complete appropriate Standard Operating procedure training therapeutic area training protocol training and any relevant training required to perform job duties Administer protocol and related study training to assigned sites and establish regular lines of communication with sites to manage ongoing project expectation and activities Ensure the quality and integrity of study conducted at site level in accordance with protocol and applicable regulations Investigate and discuss quality issues with Clinical Project Manager for resolution and implementation of Corrective Action and Preventive Action Manage the progress and performance of the assigned study sites by following activities but not limited to tracking regulatory and Ethics Committee submissions and approvals subject recruitment case report form CRF completion and submission and data query generation and resolution Create and maintain appropriate documentation regarding site management monitoring visit findings and action plans by submitting regular visit reports generating follow-up letters and other required study documentations Provide assistance to the Clinical Project Manager with design of study tools documents and processes Timely submission of timesheets for Project specific and other tasks Supporting the Clinical Project Manager for coordination with-in the project team Delegation of project level Clinical Project Manager responsibilities Educational Qualification Masters Degree in Life Science Masters in Pharmacology Technical functional Skills Maximum 4-6 Points Sound knowledge on ICH-GCP and Indian Regulatory guidelines Well versed with Microsoft Office documents MS word Excel Powerpoint Knowledge about developing SOPs Well versed with facing internal and external audits Experience Mini 3-5 years in core clinical research activities in Clinical Research Activities Behavioral Skills Proficient in English reading and writing Stress Management Empathy Conflict resolution and Patience 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