394004BR
Apr 16, 2024
Denmark
About the Role
Copenhagen, Denmark (Hybrid) #LI Hybrid
We are seeking a Clinical Research Medical Advisor to provide clinical strategic and tactical leadership in the country to support GDD trials, clinical development plans which change the world, concept sheets/protocols and other clinical documents. You will closely collaborate with the Trial Monitoring Organisation and Medical Affairs to ensure successful allocation, fast clinical trial start up, recruitment according to planned timelines, early identification of potential delays and mitigation plan.
This role will work directly with the GDD CD&A/Clinical Execution/CRMA team and reports to the Clinical Research Medical Head.
Key Responsibilities:
• Managing and day-to-day support provided in program/trial level quality issues, deviations and quality events management.
• Co-owning start-up phase and the recruitment plan for development clinical trials with the local TMO organization.
• Providing robust indication and protocol training to CRAs and CSEs, and other functions in the country as needed.
• Providing protocol, Risk management plan & disease training as appropriate, and externally at Investigator’s Meetings or scientific venues to support recruitment and trial awareness.
• Assessing 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.
• Reviewing 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.
We are seeking a Clinical Research Medical Advisor to provide clinical strategic and tactical leadership in the country to support GDD trials, clinical development plans which change the world, concept sheets/protocols and other clinical documents. You will closely collaborate with the Trial Monitoring Organisation and Medical Affairs to ensure successful allocation, fast clinical trial start up, recruitment according to planned timelines, early identification of potential delays and mitigation plan.
This role will work directly with the GDD CD&A/Clinical Execution/CRMA team and reports to the Clinical Research Medical Head.
Key Responsibilities:
• Managing and day-to-day support provided in program/trial level quality issues, deviations and quality events management.
• Co-owning start-up phase and the recruitment plan for development clinical trials with the local TMO organization.
• Providing robust indication and protocol training to CRAs and CSEs, and other functions in the country as needed.
• Providing protocol, Risk management plan & disease training as appropriate, and externally at Investigator’s Meetings or scientific venues to support recruitment and trial awareness.
• Assessing 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.
• Reviewing 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.
Diversity & Inclusion / EEO
We are committed to building an outstanding, inclusive work environment and diverse teams representative of the patients and communities we serve.
Role Requirements
Essential Requirements:
• A scientific degree.
• Fluency in English (both written and oral).
• Fluency in Danish (both written and oral).
• 3 Years clinical development experience in pharmaceutical industry.
• Sound understanding of the overall clinical development and ICH/GCP.
• Trained in relevant aspects of clinical drug development including GCP, local regulatory requirements and data privacy laws.
• Ability to manage a study from the medical/clinical perspective, and a demonstrated capability to problem solve and mediate complex-clinical / medical / operational issues.
• Agility to move fast across different therapeutic areas and indications.
Desirable requirements:
• A medical degree.
Why Novartis? Our purpose is to reimagine medicine to improve and extend people’s lives and our vision is to become the most valued and trusted medicines company in the world. How can we achieve this? With our people. It is our associates that drive us each day to reach our ambitions. Be a part of this mission and join us! Learn more here: https://www.novartis.com/about/strategy/people-and-culture
You’ll receive: You can find everything you need to know about our benefits and rewards in the Novartis Life Handbook. https://www.novartis.com/careers/benefits-rewards
Commitment to Diversity & Inclusion: Novartis is committed to building an outstanding, inclusive work environment and diverse teams’ representative of the patients and communities we serve.
Commitment to Diversity & Inclusion: Novartis is committed to building an outstanding, inclusive work environment and diverse teams’ representative of the patients and communities we serve.
Join our Novartis Network: If this role is not suitable to your experience or career goals but you wish to stay connected to hear more about Novartis and our career opportunities, join the Novartis Network here: https://talentnetwork.novartis.com/network
• A scientific degree.
• Fluency in English (both written and oral).
• Fluency in Danish (both written and oral).
• 3 Years clinical development experience in pharmaceutical industry.
• Sound understanding of the overall clinical development and ICH/GCP.
• Trained in relevant aspects of clinical drug development including GCP, local regulatory requirements and data privacy laws.
• Ability to manage a study from the medical/clinical perspective, and a demonstrated capability to problem solve and mediate complex-clinical / medical / operational issues.
• Agility to move fast across different therapeutic areas and indications.
Desirable requirements:
• A medical degree.
Why Novartis? Our purpose is to reimagine medicine to improve and extend people’s lives and our vision is to become the most valued and trusted medicines company in the world. How can we achieve this? With our people. It is our associates that drive us each day to reach our ambitions. Be a part of this mission and join us! Learn more here: https://www.novartis.com/about/strategy/people-and-culture
You’ll receive: You can find everything you need to know about our benefits and rewards in the Novartis Life Handbook. https://www.novartis.com/careers/benefits-rewards
Commitment to Diversity & Inclusion: Novartis is committed to building an outstanding, inclusive work environment and diverse teams’ representative of the patients and communities we serve.
Commitment to Diversity & Inclusion: Novartis is committed to building an outstanding, inclusive work environment and diverse teams’ representative of the patients and communities we serve.
Join our Novartis Network: If this role is not suitable to your experience or career goals but you wish to stay connected to hear more about Novartis and our career opportunities, join the Novartis Network here: https://talentnetwork.novartis.com/network
Why Novartis: Helping people with disease and their families takes more than innovative science. It takes a community of smart, passionate people like you. Collaborating, supporting and inspiring each other. Combining to achieve breakthroughs that change patients’ lives. Ready to create a brighter future together? https://www.novartis.com/about/strategy/people-and-culture
Join our Novartis Network: Not the right Novartis role for you? Sign up to our talent community to stay connected and learn about suitable career opportunities as soon as they come up: https://talentnetwork.novartis.com/network
International
Region Europe IMI
Denmark
Copenhagen
NOV HLTCR DNK
Research & Development
Full Time
Regular
No
