Job Description

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.

Skills Required