Syngene International Ltd
Designation: Associate Manager - Clinical Investigator
Job Location: Bangalore
Department: Clinical Development Human Pharmacology Unit
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.
To supervise and conduct the clinical research [Phase I/BABE studies] in compliance with Good Clinical Practice and applicable regulatory requirement.
Supervise or personally conduct the clinical research in compliance with Good Clinical Practice and to the ethical principles that have their origin in the declaration of Helsinki and as per protocol and applicable regulatory requirement.
Responsible for the day-to-day supervision of the Human Pharmacology Unit operation and staff performing different functions.
Have a thorough Knowledge of the Investigational medicinal product, protocol and the contents of the investigator's brochure. Evaluation of the adverse events and their effective management.
Provide Interim and final reports to Ethics Committee, as per the regulatory requirements.
Update Sponsor, Ethics Committee and regulatory authorities as and when required and as applicable.
Identifying training needs and assuring that each individual performing activity receives regular training.
Responsible for periodic review of SOPs/IOPs.
Liaison with Quality Assurance Department for external sponsor audits, internal audits or any other regulatory inspection.
Ensure the accuracy, completeness, traceability, legibility, and timeliness of the data reported to the sponsor.
To carry out any other responsibility as and when assigned by the Head-Human Pharmacology Unit.
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 company.
Educational Qualification: MBBS
Should have the ability to perform thorough medical review of volunteers and manage medical emergencies.
Should have managed a team of 3-5 members involved in performing research related activities.
Experience: 0-4 year
Adapt to changes,
Effective Planning and Organizing skills.
Good Business/Industry Awareness.
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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