Senior Associate, Central Monitor, Risk based Monitoring
About the job
Job Location: Bangalore
Are you experienced Clinical research professional and passionate about clinical trials? Does being part of a growing, yet dynamic environment excite you? If yes, then you may be the one we are looking as Study Start-Up Specialist (SSUS) for Novo Nordisk India, Bangalore.
Purpose of the job
As a SSUS, you will be responsible for the start-up activities for Clinical Trials managed in Clinical Development Centre-India (CDC). The scope of start-up activities for a particular clinical trial may vary with respect to countries sponsored by Novo Nordisk India in accordance with Good Clinical Practice (GCP) guidelines and in line with local regulatory requirements. Start-up activities start post project allocation to country and ends at completion of Site Initiation Visits. In this role your main responsibility will be to conduct feasibility with sites for new clinical trials and site selection, customisation and translations of study documents, Health Authority and Ethics Committee submissions, prepare country budget, negotiations & contract preparations. SSUS will also be responsible for supplies management and payments, documents review and upload in systems, filing and maintaining Trial Master File and any tasks assigned as per project needs in compliance with local regulations, ICH- GCP, Novo Nordisk procedures and protocol requirements.
Qualifications
Below are the required skills.
- Graduate/Post-Graduate in Science, Pharmacy or Medical. Additional Qualification in Clinical Research would be preferred.
- At-least 2 years of work experience as CRA/monitor or experience in end-to-end study start-up activities. Candidate having experience with India and or APAC study start-up activities will be given preference.
- You are required to be trained in ICH-GCP guidelines and if applicable certification is also preferred.
- Should have strategic and analytical capabilities, with demonstrated experience in analysing complex situations. Should be able to work with different stakeholders and prioritize various activities as per project timelines and objectives.
- A strong track record in thorough planning, execution and follow-up is required, with a creative and innovative attitude that will enable you to drive initiatives with operational excellence in mind.
About The Department
Novo Nordisk is a Denmark based multinational with leadership in diabetes. Novo Nordisk India affiliate office is in Bangalore & has more than 1,400 people working across the country in various functions. The position Study Start-Up Manager) reports directly to the Head of Study Start-Up Team and demands responsibility to develop and deliver project plan and site start up activities from site identification, through feasibility, and to site activation by partnering with Project Management, Clinical Operations, and other study stakeholders. Additionally, (s)he will oversee the analysis of clinical trial data and its application to conduct accurate study start-up forecasts as well as to drive rapid, accurate, and data-driven study start-up forecasts, benchmarking assumptions, scenarios, and accurate planning.
