Job Title

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 spiritMandatory expectation for all roles as per Syngene safety guidelinesOverall 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 selfCompliance to Syngene’ s quality standards at all timesPrincipal Investigator for early phase trials:Review of RFX and feasibility. Provide crucial insights and anticipate risks and provide solutions.Co-ordinate with PMO, Bio-analytical, Statistical, Finance, Regulatory, Central Lab, Legal and Administration departments for development and execution of the projects.To assure that the rights and welfare of the research subjects are guaranteed, correctly and obtaining the signature of the informed consent form.Supervise or personally conduct the 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.Assure that all study subjects have been informed of their obligations pursuant to the research protocol.Provide resources, staff and facilities including instruments and equipment required for the timely conduct and conclusion of the study.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.Be aware of medical decisions and adverse event treatment.Comply with the study protocol. Signature of the agreement and of the protocol;Responsible for Supervision of Trial Master file with the required documents maintenance by designated in charges.Responsible to provide protocol training and other study related update/information to staff involved in the conduct of a study.Facilitate the access of documents to the monitor and/or for audits/ inspections. To assign responsibilities for the designees, or to authorize the conduct of study phases in third centers. The authorization should be formally documented and submitted to the competent agencies, and approved as appropriate.Will be responsible for withdrawing a study subject in circumstances as described in the study protocol or if such action appears in the subject’s best interest.To co-ordinate for the approval by Ethics Committee and the necessary reviews.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 trainingResponsible for periodic review of SOPs/IOPs.Responsible for investigational product accountability.Responsible to follow the study randomization procedures, if any, and should ensure that the code is broken only in accordance with the protocol.Review and approval of the Clinical Study Report.Liaison with Quality Assurance Department for external sponsor audits, internal audits or any other regulatory inspection.Ensure Attributable, legible, contemporaneous, original and accurate data reported to the sponsor in the CRFs and in all required documents.To carry out any other responsibility as and when assigned by the Head-Human Pharmacology Unit / Head of Syngene Clinical Development Team.Review Quality metrics- audit finding indices, power BI data analysis and propose action plans for continuous improvementReduce redundancy and work towards Operational ExcellenceDeveloping and cascading the organizations strategy/mission statement to the lower ranking staff and implementing appropriate rewards/recognition and coaching/corrective practices to align personnel with company goals.Syngene ValuesAll employees will consistently demonstrate alignment with our core valuesExcellenceIntegrityProfessionalismExperience: More than 10 yearsTECHNICAL /FUNCTIONAL SKILL:Sound knowledge on conduct of BA/BE studies and phase one studies.Sound understanding of GCP and regulatory requirements.Effective communication skills both written and verbal.BEHAVIORAL/MANAGERIAL SKILLS:Commitment to Syngene core values –ExcellenceProfessionalismIntegrityGood Interpersonal skillsTeam & Time managementRelationship management – Internal & ExternalPositive attitudeCustomer CentricResult orientedProactive & Continuous improvementReady to accept any new challenges/LearningsCommitment to safety demonstrated by adhering to following behaviors.Overall adherence to safe practices and procedures of oneself and the teams alignedContributing to development of procedures, practices and systems that ensures safe operations and compliance to company’s integrity & quality standardsEqual Opportunity EmployerIt 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.