Job Location: Translational Health Science and Technology Institute (TSHTI) - Faridabad, Haryana
Department: Human Pharmacology Unit - Translational & Clinical Research
About Syngene: Syngene (www.syngeneintl.com) is an innovation-led contract research, development and manufacturing organization offering integrated scientific services from early discovery to commercial supply.
At Syngene, safety is at the heart of everything we do personally and professionally. Syngene has placed safety at par with business performance with shared responsibility and accountability, including following safety guidelines, procedures and SOPs, in letter and spirit
Mandatory expectation for all roles as per Syngene safety guidelines
Overall adherence to safe practices and procedures of oneself and the teams aligned
Contributing to development of procedures, practices and systems that ensures safe operations and compliance to company’s integrity & quality standards
Driving a corporate culture that promotes environment, health, and safety (EHS) mindset and operational discipline at the workplace at all times.
Ensuring safety of self, teams and lab/plant by adhering to safety protocols and following environment, health, and safety (EHS) requirements at all times in the workplace.
Ensure all assigned mandatory trainings related to data integrity, health, and safety measures are completed on time by all members of the team including self
Compliance to Syngene’ s quality standards at all times
Hold self and their teams accountable for the achievement of safety goals
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Govern and Review safety metrics from time to time
Role Accountabilities
Responsible for planning, coordination and overviewing of study-related activities.
Coordinating with Ethics Committee for review of study-related documents.
Submission of required documents to Ethics Committee on time for review and approval.
Submission of study schedule to Ethics Committee.
Submission of study updates / summary reports to Ethics Committee.
Reporting major protocol deviations or violations that affect participant safety to Ethics Committee.
Reporting SAE and submission of detailed reports of the same to Ethics Committee.
Maintaining all EC-approved general documents (such as advertisements for recruitment of volunteers/participants, compensation plans for research participants, screening CRF, registration consent, general screening consent, Pre-HIV and Post-HIV test forms, etc.) and communication details in appropriate files.
Arranging protocol training and assisting investigators in delegation of activities to study personnel as per their job responsibilities.
Coordinating with investigators, screening teams, and study teams during the conduct of the study.
Coordinating with the PMO team to assist with monitoring visits.
Coordination with other departments (Central Laboratory, Bioanalytical Laboratory, and Data Management) during the conduct of the study. Accompanying and assisting study-specific monitors during monitoring activities as per the monitoring plan.
Arrange study ICDs and CRFs and coordinate with the Document Controller for final issuance.
Responsible for requesting the QA/Document Controller (DC) team to issue the required number of study forms and CRFs well before the start of the study.
Responsible for collecting study forms and CRFs from the QA/DC team for study activities as per the given request and handing them over to the respective activity in-charge personnel for documentation.
Responsible for handing over completed and reviewed CRF forms to QC personnel after filing them in the respective study file.
Ensure readiness of essential documents in the Trial Master File.
Responsible for filing duly completed CRF forms in the respective study files.
Coordinate with QCs for the documentation review process.
In-charge of movement of study files from HPU to QA/QC and CDM for review and scanning.
Coordinate for resolution and closure of QC, QA, monitor, and sponsor observations/reports.
Manage DCFs issued by CDM and address study-related queries with staff, CI, and PI.
Retrieve archived study documents to resolve regulatory and sponsor queries, ensuring proper re-archival.
Responsible for providing reconciliation of all study-related issued forms for QC check and submitting the final copy to the Document Controller (DC)/QMS.
Preparation of periodic study updates and coordination with the Project Manager for providing study updates or any operational documents to the sponsor.
Coordination with Investigators for providing periodic study updates and clinical summary reports to the Ethics Committee (EC).
Archival of all study files.
To carry out other responsibilities that may be assigned by the Principal Investigator, Head - Human Pharmacology Unit / Head - Syngene Translational & Clinical Research.
Leadership Capabilities
Syngene Values
All employees will consistently demonstrate alignment with our core values
Excellence
Integrity
Professionalism
Experience: 8 to 13 years
Education: Master’s in Science (M.Sc.)
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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