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- Clinical Research Manager
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www.cvonline.hu
Hozzáadva: 2014.07.04.
Jelentkezési határidő: 2014.08.12.
Hirdetés azonosító: 829977
lejárt
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Bérszámfejtő
Clinical Research Manager
Régió: Budapest
Hozzáadva: 2014.07.04.
Jelentkezési határidő: 2014.08.12.
Hirdetés azonosító: 829977
lejárt
Clinical Research Manager
Our Pharmaceutical Client is looking for a seasoned clinical research professional to join their talented team in the following role:
Clinical Research Manager
Purpose of the opportunity:
The CRM has a significant impact on how a country can deliver country-specific trial commitments and objectives. As a customer-facing role, this position will build business relationships and represent Company with investigators, functional outsourcing partners and other external partners and therefore have a significant impact on country-level customer relationships. The position requires the ability to make decisions independently and oversee important activities relevant to clinical research activities in the country according to predetermined global policies and commitments with the support, oversight and supervision of the Country Research Director.
Requires strong understanding of local regulatory environment for the individual to weigh pros and cons of key decisions with input from manager.
Main sphere of activities:
• The incumbent is accountable for the performance for assigned protocols in a country in compliance with ICH/GCP and country regulations, Company policies and procedures, quality standards and adverse event reporting requirements internally and externally.
• The CRM is the country point of contact (POC) for assigned protocols between ROC and CO and pro-actively drives/tracks execution and performance of deliverables/timelines/results to meet country commitments, requiring strong collaboration with local Country Operations roles. The CRM forecasts country resource needs and serves local business needs (signs contracts, manages budgets as delegated).
• The CRM is responsible for quality and compliance for assigned protocols in the country and oversees CRAs and/or CTCs and training compliance. Performs quality control visits, reviews Monitoring Visit Reports and escalates performance issues and training needs to functional vendor and internal management as needed.
• The CRM is responsible for collaboration and relationship management with investigators for insourced and outsourced studies, with functional outsourcing vendors and other external partners. The CRM oversees country and site validations, site selection and recruitment in assigned protocols.
• The CRM is responsible for clinical trial education to sites, and acts as the country POC for programmatically outsourced trials for assigned protocols. In collaboration with CRD, represents Company in Pharma industry issues and in seeking influence in external R&D environment.
• The CRM collaborates internally with GMA/GHH, local PV and Regulatory Affairs to align on key decisions in countries. Supports local and regional strategy development consistent with long-term corporate needs in conjunction with CRD and Regional
Operations. The position requires coordination and alignment with the regional and
broader organization.
Main requirements:
• 8-10 years of clinical research experience for a MS/MBA/JD; 3-6 years for an MD-PhD
• Strong understanding of clinical trial planning, (site)management and metrics
• Strong communication, educational/pedagogic, diplomatic and empathic skills.
• Strong leadership skills (scientific and business) and proven ability to coordinate and lead local teams to high performance.
• Strong organizational skills with demonstrated success required.
• Ability to lead across several dimensions simultaneously.
• Excellent oral and written English and Hungarian language skills.
• Problem solving and conflict resolution
• Negotiation skills with both internal and external groups
Our Client can offer competitive compensation and innovative work environment.
Munkavégzés helye: Budapest
Clinical Research Manager
Purpose of the opportunity:
The CRM has a significant impact on how a country can deliver country-specific trial commitments and objectives. As a customer-facing role, this position will build business relationships and represent Company with investigators, functional outsourcing partners and other external partners and therefore have a significant impact on country-level customer relationships. The position requires the ability to make decisions independently and oversee important activities relevant to clinical research activities in the country according to predetermined global policies and commitments with the support, oversight and supervision of the Country Research Director.
Requires strong understanding of local regulatory environment for the individual to weigh pros and cons of key decisions with input from manager.
Main sphere of activities:
• The incumbent is accountable for the performance for assigned protocols in a country in compliance with ICH/GCP and country regulations, Company policies and procedures, quality standards and adverse event reporting requirements internally and externally.
• The CRM is the country point of contact (POC) for assigned protocols between ROC and CO and pro-actively drives/tracks execution and performance of deliverables/timelines/results to meet country commitments, requiring strong collaboration with local Country Operations roles. The CRM forecasts country resource needs and serves local business needs (signs contracts, manages budgets as delegated).
• The CRM is responsible for quality and compliance for assigned protocols in the country and oversees CRAs and/or CTCs and training compliance. Performs quality control visits, reviews Monitoring Visit Reports and escalates performance issues and training needs to functional vendor and internal management as needed.
• The CRM is responsible for collaboration and relationship management with investigators for insourced and outsourced studies, with functional outsourcing vendors and other external partners. The CRM oversees country and site validations, site selection and recruitment in assigned protocols.
• The CRM is responsible for clinical trial education to sites, and acts as the country POC for programmatically outsourced trials for assigned protocols. In collaboration with CRD, represents Company in Pharma industry issues and in seeking influence in external R&D environment.
• The CRM collaborates internally with GMA/GHH, local PV and Regulatory Affairs to align on key decisions in countries. Supports local and regional strategy development consistent with long-term corporate needs in conjunction with CRD and Regional
Operations. The position requires coordination and alignment with the regional and
broader organization.
Main requirements:
• 8-10 years of clinical research experience for a MS/MBA/JD; 3-6 years for an MD-PhD
• Strong understanding of clinical trial planning, (site)management and metrics
• Strong communication, educational/pedagogic, diplomatic and empathic skills.
• Strong leadership skills (scientific and business) and proven ability to coordinate and lead local teams to high performance.
• Strong organizational skills with demonstrated success required.
• Ability to lead across several dimensions simultaneously.
• Excellent oral and written English and Hungarian language skills.
• Problem solving and conflict resolution
• Negotiation skills with both internal and external groups
Our Client can offer competitive compensation and innovative work environment.
Munkavégzés helye: Budapest
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