[Apply in 3 Minutes] Project Associate, Clinical Trials

1 day ago

Bangalore Karnataka, India Syngene International Full time

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 The Clinical trial Assistant plays a significant role in maintaining the study specific documentations of the clinical trials Key Responsibilities Maximum 5-8 Points Assist Clinical Project Manager CPM and Clinical Research Associates all levels by accurately updating and maintaining clinical systems that track site compliance and performance within project timelines Assist the clinical team in the preparation handling distribution filing and archiving of clinical documentation and reports according to the scope of work and standard operating procedures Assist with periodic review of study files for accuracy and completeness Assist Clinical Project Manager and Clinical Research Associates all levels with preparation handling and distribution of Clinical Trial Supplies and maintenance of tracking information Assist with the tracking and management of Case Report Forms CRFs queries and clinical data flow Act as a central contact for the study team for designated project communications correspondence and associated documentation Perform assigned administrative tasks to support team members with clinical trial execution Coordinate with Quality Assurance in providing TMFs Trial Master File In-house during the In-house Audit Secondary contact between site external vendors internal team members and cross-departments for study level activities Co-ordinate with translation agency for getting relevant study documents translated and back translated as required for the study Timely submission of timesheets for Project specific and other tasks 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 1-3 years in clinical research activities in Clinical Operations Behavioral Skills Proficient in English reading and writing Integrity 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

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