Job Description

Job description Location - Bangalore Purpose of the job Coordinate, in partnership with the COM (Clinical Operation Manager) and CDC-TM (Trial Managers), the clinical trial set-up at a local level to ensure appropriate site and resources allocation. Manage local clinical projects, ensuring they are executed in a timely and effective manner, within budget and complying with regulatory requirements, Helsinki Declaration, GCP (Good Clinical Practice) and NN SOPs (Standard Operating Procedures). Provide clinical trial related communication and insight to internal and external stakeholders. Manage and coach CRAs (Clinical Research Associate). Position\'s key accountabilities Recruit and develop CRAs and implement necessary actions to improve their performance (30%) Lead quality clinical trial projects (CDP and/or local) in the country (30%) Provide trial related communication and insight to key internal and external stakeholders (25%) Coordinate the clinical trial set-up in partnership with the COM (15%) Nature and scope of Main accountabilities Recruit and Develop CRAs and implement necessary actions to improve their performance Ensure CRA are recruited on time per the departmental needs and expansion plans. Ensure CRA are allocated to all necessary trainings and are onboarded per the onboarding plan with assessments and signoff them as independent monitor. Ensure that staff is appropriately trained for the roles they are undertaking. Identify training needs and coordinate the necessary training for CRAs. Assess CRA performances per the KPI and build CRA based on the improvement areas. Appraise performance of CRAs. Define CRAs individual development plan. Provide them with new challenges and/or responsibilities in alignment with Novo Nordisk business needs. Together with the COM follow up on team members\' personal and professional development. Lead quality clinical trial projects (CDP and/or local) in the country Track tasks performed by CRAs ensuring timely and effective execution of local clinical trials. Ensure that budgets are managed in line with the plan and together with CDC-TM to update the study budget if required. Monitor that submissions / approvals are performed ontime and appropriately. Review key regulatory documentation ensuring it complies with requirements. Develop the study specific quality plan and ensure protocol execution and compliance. Co-monitor visits with the CRA and, in partnership with the COM, monitor the quality of the clinical trial execution, quality audits and inspection issues. Check the maintenance of the TMF (Trial Master File) to ensure compliance. Collaborate in site closure. Provide trial related communication and insight to key internal and external stakeholders Ensure that all data pertaining to the study status is compiled and reported. Provide key operational information to the COM, CDC-TM and update them on the clinical trial progress, elaborating reports when necessary. Provide vendors and external clients with timely project status information. Provide input to develop materials for local Investigator Meetings and monitor Training Meetings if applicable. Maintain ongoing communication with Ethics Committees and the Health Authority, ensuring the Central and local (as applicable) Ethic Committee is provided with the documents requ ested. Coordinate the clinical trial set-up in partnership with the COM Coordinate country level protocol feasibility test together with the COM. Identify sites, coordinate site assessments (if required) and elect appropriate sites to allocate local clinical trials liaising with the COM and MMs. Negotiate Clinical Trial Agreements with local Investigators and monitor the relevant payments Plan local studies and, together with the COM and CDC-TM, assign CRA. Assist CDC-TM/ CRAs in the preparation and carry out of pre-study and/or initiation visits. Collaborate with the COM in effective site recruitment, providing the necessary criteria for successful staffing. Ensure timely execution of contracts in partnership with the CDC-TM. Constantly network among institutions and academicians to identify good centres for clinical trials. Purpose and subject of interaction with internal/external customers and key contacts Extensive and proactive communication both internally and externally (investigators and site coordinators) is essential for successful implementation of main accountabilities. The position requires effective people management to develop and lead the group. Challenges with regard to innovation and change The position requires the understanding of ICH/GCP, local requirements and Novo Nordisk SOPs. The position requires adapting changes and managing the group and clinical trials responsible for. The position requires innovative use of new IT systems (e.g. e-learnings, EDC, IWRS, eTMF, NovoTime, COSMOS). To what extent the job has to be performed abroad The position requires some travelling and flexible working hours as the activities are carried out in accordance with the physicians\' available time and clinics. Majority of the travels are expected within the country but there will be some travels abroad as well. Education requirements Graduate or Post Graduate Degree or higher qualifications in Pharmacy, Life Sciences or other related field. Proficiency in both verbal and written English. Work experience At least 6 years of experience in conducting clinical trials as CRA and/or Trial Manager. Contact To submit your application, please upload your CV and motivational letter online (click on Apply and follow the instructions). Deadline 8th May 2023 We commit to an inclusive recruitment process and equality of opportunity for all our job applicants. At Novo Nordisk we recognize that it is no longer good enough to aspire to be the best company in the world. We need to aspire to be the best company for the world and we know that this is only possible with talented employees with diverse perspectives, backgrounds and cultures. We are therefore committed to creating an inclusive culture that celebrates the diversity of our employees, the patients we serve and communities we operate in. Together, we\'re life changing.

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