Clinical Research Medical Advisor

Novartis

Wien
Feste Anstellung
Teilzeit, Vollzeit
Homeoffice möglich
Remote / vor Ort
Erfahren (2-5 Jahre)
Österreich
Gehalt anzeigen
Erschienen vor 1 Jahr

Leer

Deine Aufgaben

Validates study designs, is accountable for, and makes the final decision on the clinical/medical trial and program feasibility of implementing a clinical trial protocol based on medical/clinical practice and analysis of the competitive environment in the country.
Actively contributes to scientific/clinical/medical aspects of the start-up phase to ensure fast clinical trial site start-up.
Provides clinical/medical expertise to clinical trial operations team members and clinical trial sites.
Provides scientific/clinical/medical expertise during interactions with Country/Cluster external Experts (e.g., Regulatory Authorities, Medical Experts, Advisory Boards, Patient Advocacy Groups, etc.).
Develops clinical/medical trial plans taking the broader ecosystem into account for assigned pro-grams/trials to ensure successful trial implementation, which includes: Pro-actively identifying early on clinical challenges to recruitment or clinical data quality and driving development of clinical/medical mitigation plans & building disease area expertise, especially for new/rare indications.
Provides robust indication, compound, and protocol training to the clinical operations team in the country, especially to the Clinical Research Associates, and other country line functions as needed & externally as needed in the Country/Cluster at Investigator’s Meetings or scientific venues to support recruitment and trial awareness.
As the scientific/clinical/medical expert, supports and partners with internal Stakeholders (e.g., Clinical Trial Team, Regulatory Affairs, Medical Information, Medical Affairs, Marketing, Patient Access, HE&OR, clinical trial operations, etc.), and internal decision boards as needed regarding clinical trials.
Drives all clinical/medical activities in adherence to GCP (Good Clinical Practices), and in line with ICH (International Conference on Harmonization) and Country regulations.

Dein Profil

Validates study designs, is accountable for, and makes the final decision on the clinical/medical trial and program feasibility of implementing a clinical trial protocol based on medical/clinical practice and analysis of the competitive environment in the country.
Actively contributes to scientific/clinical/medical aspects of the start-up phase to ensure fast clinical trial site start-up.
Provides clinical/medical expertise to clinical trial operations team members and clinical trial sites.
Provides scientific/clinical/medical expertise during interactions with Country/Cluster external Experts (e.g., Regulatory Authorities, Medical Experts, Advisory Boards, Patient Advocacy Groups, etc.).
Develops clinical/medical trial plans taking the broader ecosystem into account for assigned pro-grams/trials to ensure successful trial implementation, which includes: Pro-actively identifying early on clinical challenges to recruitment or clinical data quality and driving development of clinical/medical mitigation plans & building disease area expertise, especially for new/rare indications.
Provides robust indication, compound, and protocol training to the clinical operations team in the country, especially to the Clinical Research Associates, and other country line functions as needed & externally as needed in the Country/Cluster at Investigator’s Meetings or scientific venues to support recruitment and trial awareness.
As the scientific/clinical/medical expert, supports and partners with internal Stakeholders (e.g., Clinical Trial Team, Regulatory Affairs, Medical Information, Medical Affairs, Marketing, Patient Access, HE&OR, clinical trial operations, etc.), and internal decision boards as needed regarding clinical trials.
Drives all clinical/medical activities in adherence to GCP (Good Clinical Practices), and in line with ICH (International Conference on Harmonization) and Country regulations.

Deine Benefits:

Attractive incentive program
Modern company pension scheme
Childcare facilities
Learning and development opportunities
Worldwide career possibilities within the Novartis group
Support for part-time and job-sharing models
Flexible and remote working options

Weitere Informationen

Bevorzugte Sprachen:

Deutsch

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Ansprechperson

Novartis

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