Senior Executive - Project Associate

Job Description

Designation: Senior Executive Project AssociateJob Location: BangaloreDepartment: Clinical DevelopmentAbout 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: To manage in-house regulatory documentation and project related activities & to coordinate with the site for documentation and other activities of coordination.Key Responsibilities: Assist Clinical Project Manager (CPM) and Clinical Research Associates (CRAs) with 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 CPM/ CRA 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 QA in providing TMFs (Trial Master File) (In-house) during the In-house Audit. Secondary contact between site and Clinical Research Organization (CRO) for study level activities Co-ordinate with translation agency for getting relevant study documents translated and back translated as required for the study Act as a secondary contact to coordinate with external vendors & internal team members for the smooth execution of the study Timely submission of timesheets for Project specific and other tasks Follow environment, health, and safety (EHS) requirements at all times in the workplace ensuring individual and lab/plant safety Attend training on environment, health, and safety (EHS) measures imparted companyEducational Qualification: Graduate in Life Sciences Masters in Life ScienceTechnical/functional Skills: Should have knowledge of regulatory requirements of India and other global countries, Indian guidelines, European Medicines Agency (EMA) and Food and Drug Administration (FDA) On site experience as a coordinator Coordinating with sites and doctors for various documentationsExperience: At least 3 years of relevant Project Associate experienceBehavioral Skills: Good communication Quick learner Adapt to changes Time management ProfessionalismEqual 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.,

Keyskills :
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