Job Description:
Clinical Research Manager-CLI003686
Descripción
GCTO is transforming into a new operating model. Project management activities will be centralized in a regional operations center. At the Country Operations level, the CRM has a significant impact on the ability to effectively conduct clinical studies and develop the pipeline, while maintaining local regulatory and compliance requirements.
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 Merck/MSD 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.
Primary activities/responsibilities
• The incumbent is accountable for the performance for assigned protocols in a country in compliance with ICH/GCP and country regulations, Merck 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 Merck/MSD 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.
• The ability to identify problems, conflicts and opportunities early and lead, analyse and prepare mitigation plans and drive conflict resolution is critical. The position requires skilful negotiation in tough situations with both internal and external groups; settle differences with minimum noise; win concessions without damaging relationships; be direct and forceful as well as diplomatic; gain trust quickly from other parties in negotiations and have an excellent sense of timing. Examples of common problems include: 1) low patient recruitment, 2) inadequate staff to meet business needs, 3) performance or compliance issues, 4) working with regulatory issues and the broader organization, and 5) resolution of conflictive situations on country level.
Calificaciones
• Minimum Bachelor's degree, desire Master of Science or Medicine (or comparable).
• 8-10 years of clinical research experience for a BS/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 language skills.
• Problem solving and conflict resolution
• Negotiation skills with both internal and external groups
Puesto: Investigación clínica genérica Job Title:Assoc. Dir, Clinical Research
Ubicación principal: LATAM-Argentina
Estado de empleado
: Fijo
Número de ofertas de trabajo
: 1
Additional Info:
[Click Here to Access the Original Job Post]
Clinical Research Manager-CLI003686
Descripción
GCTO is transforming into a new operating model. Project management activities will be centralized in a regional operations center. At the Country Operations level, the CRM has a significant impact on the ability to effectively conduct clinical studies and develop the pipeline, while maintaining local regulatory and compliance requirements.
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 Merck/MSD 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.
Primary activities/responsibilities
• The incumbent is accountable for the performance for assigned protocols in a country in compliance with ICH/GCP and country regulations, Merck 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 Merck/MSD 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.
• The ability to identify problems, conflicts and opportunities early and lead, analyse and prepare mitigation plans and drive conflict resolution is critical. The position requires skilful negotiation in tough situations with both internal and external groups; settle differences with minimum noise; win concessions without damaging relationships; be direct and forceful as well as diplomatic; gain trust quickly from other parties in negotiations and have an excellent sense of timing. Examples of common problems include: 1) low patient recruitment, 2) inadequate staff to meet business needs, 3) performance or compliance issues, 4) working with regulatory issues and the broader organization, and 5) resolution of conflictive situations on country level.
Calificaciones
• Minimum Bachelor's degree, desire Master of Science or Medicine (or comparable).
• 8-10 years of clinical research experience for a BS/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 language skills.
• Problem solving and conflict resolution
• Negotiation skills with both internal and external groups
Puesto: Investigación clínica genérica Job Title:Assoc. Dir, Clinical Research
Ubicación principal: LATAM-Argentina
Estado de empleado
: Fijo
Número de ofertas de trabajo
: 1
Skills :
Areas :
Additional Info:
[Click Here to Access the Original Job Post]