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Job Location | Bangalore, Chennai, Hyderabad, Kolkata |
Education | Not Mentioned |
Salary | Not Disclosed |
Industry | Pharma / Biotech |
Functional Area | Allied Health Services,Sales / BD |
EmploymentType | Full-time |
Designation: Assistant Manager Clinical Data ManagementJob 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 lead Clinical Data Management.Key Responsibilities: Project Manager for all data management projects. Responsible for execution of data management activities for all clinical projects. Leading, mentoring and training data management team members. Reviewing data management plan. Providing inputs for proposal. Performing quality checks for the data points. Raising queries to clarify the discrepancy. Updating the resolved queries in database for paper studies. Initiating the process of data quality reviews. Provide inputs for Consent Requisition Form (CRF) designing. Responsible for the quality of data that is being collected and processed. Preparing and reviewing standard operating procedures. Initiate the process of data quality review and delegate BM personnel to act as a data quality reviewer for the specific study. Conducting periodic performance appraisal for the direct reportees. Any other responsibilities assigned by the organization from time to time. Possess the knowledge and exposure to environment, health, and safety (EHS) practices Follow environment, health, and safety (EHS) requirements at all times in the workplace ensuring individual and lab/plant safetyEducational Qualification: M. Sc (Life Sciences/Basic Science) / M. Pharm or Ph. D (Life Science)Technical/functional Skills: Good Knowledge on the ICH-GCP (Good Documentation Practice) Knowledge on the Clinical trial process (Phase 1 to Phase IV) Good at MS office (Excel, Word and PPT) Ensure environment, health, and safety (EHS) measures are imparted via training and adhered within the team.Experience: At least 10 years of experience in Clinical Research.Behavioral Skills: Leadership qualities Integrity Good Communication skillsEqual 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 :
music makingconsumer goodstatequal employment opportunitymiscontinuous improvement facilitationanimal healthaccountsclinical datasalesclinical developmentdata qualityms officedata managementbanking