Clinical Research Medical Advisor
- NOVARTIS
- 2 - 5 Years
- Hyderabad
- 4 years ago
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Job Description
Job Description:300+ associates. Join a team of globally collaborative colleagues at the Global Clinical Supply (GCS) function to support clinical trials from Phase 1 to approval and be a key interface between Technical Research & Development teams and the Clinical teams!
At GCS, we aspire to become an intelligent, agile organization to deliver more products to more patients efficiently, through empowered and highly capable teams. As a Clinical Trial Supply Manager, you would be a trusted business partner designing & delivering clinical supplies to serve our patients with excellence.
Your responsibilities:
Your responsibilities include, but are not limited to:
Provide clinical development and indication expertise specific to a country and drives together with the local TMO organization execution of clinical trials with high quality and in planned timelines: Closely collaborates with the Trial Monitoring Organisation to ensure fast clinical trial start up, recruitment according to planned timelines, early identification of potential delays and robust recruitment mitigation plan. Co-own start-up phase and the recruitment plan for development clinical trials with the local TMO organization.
Provides robust indication and protocol training to CRAs and CSEs, and other functions in the country as needed. Provide protocol, Risk management plan & disease training as appropriate, and externally at Investigators Meetings or scientific venues to support recruitment and trial aware-ness.
Assess the clinical feasibility of implementing a clinical trial protocol based on regional/local medical practice using physician interviews, local databases (RWE, payer data, patient association feed-back, etc.) and analysis of the competitive environment. Provide medical/clinical assistance to TMO and site for IEC/IRB Interactions
Review country or site-specific Informed Consent Forms (ICF) and ensure accuracy of translation of information related to Development clinical trials /NIBR PoC studies when translated into the local language, including the patient narrative where appropriate
Support Ministry of Health interaction (or local Board of Health) as required. Support Regulatory Affairs, Health Economics, Drug safety and epidemiology and Medical Information with medical/clinical input as appropriate as this relates to global development clinical trials and NIBR PoC trials. Support planning, implementation and follow-up of regulatory agency inspections and internal audits.
Review and try to resolve local medical issues / questions and, if feasible, support TMO with recruitment/ operational issues that arise during the entire course of the study if necessary, support the discussion of issues to global teams. Perform local AE review for development compounds and provide general medical support for safety issues, Provide medical expertise support to pharmacovigilance activities
Responsible to review the medical aspects of clinical trial SAEs occurring in the country and support patient safety team, if needed follow-up with the Investigator for additional information or clarifications as needed, when necessary, provide medical expertise to Clinical Operations activities for safety amendments, INs, etc.
May be called upon to provide clinical/medical strategic and tactical input into clinical development plans and protocol designs at a global level. May also serve as CO representative in Region-al/Global team. Identify high quality local/regional datasets (e.g. registries etc) which could be used to drive innovative study designs or support recruitment
Drive all scientific activities in adherence to GCP (Good Clinical Practices), and in line with ICH (International Conference on Harmonization) and local regulations. Participation in Early product planning process to ensure that TMO trials conducted optimize cross-functional CO strategy. Participate in global working groups in order to support and improve processes for the CD&A/CRMA Line function.
Minimum requirements:
What youll bring to the role:
MBBS / MD
Trained in relevant aspects of clinical drug development including GCP, local regulatory requirement sand data privacy laws.
Subspecialty training desirable, but not required.
At least 3 Years clinical development experience in pharmaceutical industry
Sound understanding of the overall clinical development and ICH/GCP
Why considers Novartis
799 million. Thats how many lives our products touched in 2019. And while were proud of that fact, in this world of digital and technological transformation, we must also ask ourselves this: how can we continue to improve and extend even more peoples lives
We believe the answers are found when curious, courageous and collaborative people like you are brought together in an inspiring environment. Where youre given opportunities to explore the power of digital and data. Where youre empowered to risk failure by taking smart risks, and where youre surrounded by people who share your determination to tackle the worlds toughest medical challenges.
Imagine what you could do at Novartis!
Commitment to Diversity & Inclusion:
Novartis embraces diversity, equal opportunity and inclusion. We are committed to building diverse teams, representative of the patients and communities we serve, and we strive to create an inclusion workplace that cultivates bold innovation through collaboration and empowers our people to unleash their full potential.
Novartis is an equal opportunities employer and welcomes applications from all suitably qualified persons.
Join our Novartis Network: If this role is not suitable to your experience or career goals but you wish to stay connected to learn more about Novartis and our career opportunities, join the Novartis Network here: https://talentnetwork.novartis.com/network
Interested candidate can apply using below link
https://jobs.brassring.com/TGnewUI/Search/home/HomeWithPreLoadPageType=JobDetails&partnerid=13617&siteid=5260&Areq=325580BR
Employement Category:
Employement Type: Full timeIndustry: Pharmaceutical
Functional Area: Pharmaceutical
Role Category: Clinical Research Associate
Role/Responsibilies: Clinical Research Medical Advisor
Contact Details:
Company: Novartis HealthcareLocation(s): Hyderabad
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NOVARTIS
A global healthcare leader, Novartis has one of the most exciting product pipelines in the industry today. A pipeline of innovative medicines brought to life by diverse, talented and performance driven people. All of which makes us one of the most rewarding employers in our field.
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