(15h Left) Sr Cra

Job Title Senior CRA Job Location Bangalore Department Clinical Operations About Syngene Syngene 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 Govern and Review safety metrics from time to time Core Purpose of the Role Perform site selection initiation monitoring and close-out visits in accordance with contracted scope of work Standard Operating Procedures and all the applicable Good Clinical Practice GCP Guidelines and Regulations Responsible for site management for the assigned protocols sites and therapeutic areas Complete appropriate Standard Operating procedure training therapeutic area training protocol training and any relevant training required to perform job duties Administer protocol and related study training to assigned sites and establish regular lines of communication with sites to manage ongoing project expectation and activities Ensure the quality and integrity of study conducted at site level in accordance with protocol and applicable regulations Investigate and discuss quality issues with Clinical Project Manager for resolution and implementation of Corrective Action and Preventive Action Manage the progress and performance of the assigned study sites by following activities but not limited to tracking regulatory and Ethics Committee submissions and approvals subject recruitment case report form CRF completion and submission and data query generation and resolution Role Accountabilities Create and maintain appropriate documentation regarding site management monitoring visit findings and action plans by submitting regular visit reports generating follow-up letters and other required study documentations Timely submission of timesheets for Project specific and other tasks Leadership Capabilities Provide assistance to the Clinical Project Manager with design of study tools documents and processes Assignment as a Lead Clinical Research Associate if required the responsibilities could include Supporting the Clinical Project Manager for coordination with-in the project team Delegation of project level Clinical Project Manager responsibilities The above responsibilities would be assigned by reporting manager and project-level task allocation would be performed Syngene Values All employees will consistently demonstrate alignment with our core values Excellence Integrity Professionalism Specific requirements for this role Experience Demonstrated Capability Education Experience 3 - 9 Years Skills and Capabilities Should have good communication skill and should be a good team player Ability to work successfully in a dynamic ambiguous environment Ability to meet tight deadlines and prioritize workloads Ability to develop new ideas and creative solutions Should be a focused employee Education M Sc M Pharm Pharm D BAMS BDS MDS BHMS Any life science 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