Job title: General Manager – Clinical Trials and Clinical Data Management-Biostatistics
Job description: Designation: General Manager Clinical Trials and Clinical Data Management-Biostatistics
Job Location: Bangalore
Department: Clinical Development
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 head following operations Clinical Trials (phase II-IV) and clinical data management, biostatistics group.
Overall management of all activities in the Clinical Trial (phase II-IV) and clinical data management, biostatistics group
Overall responsibility for meeting quality standards, timelines and budgets for all clinical trials, data management and statistics programming activities conducted
Recruitment and appointment of qualified, experienced and trained personnel to handle clinical operations functional responsibilities
Resource management – Assessment of manpower and material resource requirement and appropriate allocation of the same and nominating study specific teams as per the scope of the projects
Ensuring confidentiality of Sponsor/study related information
Ensuring ongoing training of all employees in under span of control.
Identifying specific training needs of department personnel in co-ordination with respective managers
Conducting periodic appraisal and goal setting as per Company Policy
Ensuring all operations are performed in accordance with
International Conference on Harmonisation-Good Clinical Practice (ICH-GCP) and all applicable national and international regulations and guidelines, Standard Operating Procedures (SOPs), company policy, sponsor requirements/agreements
Ensuring relevant corrective actions and preventive actions are implemented based on internal / external quality audits, sponsor audits and regulatory inspections
Periodic review and approval of Standard Operating Procedures (SOPs) and other related quality management system documents
Presenting the project status, achievements and goals in Management review meetings
Identifying and recommending key areas for improvement in the functioning of the department
Assisting in business development activities of the organization by participating in client meetings
Lead fundamentally strong, business focused and goal-oriented teams for the above functions through development of competent team leaders
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 safety
Masters/Post graduate qualification in Biological Sciences. MSc, M Pharm, PhD, MD qualification will be useful additional strength.
Should have good knowledge in medical, Good Clinical Practices, conduct of phase 2-4 clinical trial in India, regulatory guideline on Food and Drug Administration (FDA), The European Medicines Agency (EMA), World Health Organization (WHO), etc.
Ensure environment, health, and safety (EHS) measures are imparted via training and adhered within the team
Thorough understanding of data management processes applicable to clinical trials, including phase I and BA/BE studies
Broad understanding of statistical principles applicable in field of clinical research
Knowledge of medical terminologies, pharmacology, anatomy and physiology
At least 18 years of relevant Clinical Trial Management experience
Role requires bright, dynamic experienced professional with leadership qualities with a strong commitment to compliance, integrity and patient safety
Should be able to build and manage multi-level and multi-skilled teams
Excellent written and verbal communication skills, including scientific writing
Must maintain a culture of inclusiveness and integrity
Adapt to changes
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. ,
Location: Bangalore, Karnataka
Job date: Sun, 06 Jun 2021 07:26:50 GMT
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