Clinical Country Study Manager - Sandton
R
55000
per month
Sandton,
Gauteng
more than 14 days ago
Clinical Country Study Manager (AA Only)
Location: Sandton
Salary: R55000 per month
Purpose of position
As a Clinical Country Study Manager, you will be responsible for providing leadership and regional/ local strategic planning and operational delivery of assigned clinical studies through all the phases of study management (Preparation, study start-up, conduct, close-out), in accordance with quality standards, all applicable regulations, timelines and budget commitments.
Duties:
• Full accountability for all assigned studies at regional/country level (Global and local studies) including adherence to quality, timelines and budget.
• Leads local study teams, represents Country/Region Clinical Operation at the global meeting, and provides Global Teams with feedback from a local perspective.
• Coaches, and provides indirect line management support in partnership with the relevant line managers to in-house study team members (i.e. Study Start Up Specialist) by setting clear goals and expectations, monitoring performance, providing overall motivation, support, feedback and follow up to ensure team performance is fully optimized.
• Provides oversight, leadership and support to CRO staff (ie Clinical Research Associates and Clinical Trial Assistants) to ensure overall delivery at the country and site level (time, quality, and cost) and interfaces regularly with local Vendor Manager and CRO Management regarding feedback on CRO staff performance.
Requirements:
This challenging role requires the following qualification, experience and skills:
• University degree or equivalent; preferably in medical/science –related field.
• A minimum of 5 years’ experience in clinical research/development or related industry.
• Conceptualize and solve both complex and uncomplicated problems by making decisions that are aligned with results of in-depth analysis of available information.
• Leadership: developed through leading multi-functional matrix study teams through all stages of clinical studies would be preferable
• Project Management: including implementation of risk management plans and management of complex study budgets and resourcing plans
• Good knowledge of ICH GCP, quality standards related to study management.
• Clinical development experience on the operational aspects of conducting clinical studies including: vendor/CRO resource management, leading/working as part of a development team, implementing clinical development plans, risk management
• Personal Organisation: demonstrated ability to prioritize and manage multiple tasks, self-motivated and achievement driven as well as ability to influence and negotiate at all levels to achieve team delivery.
Location: Sandton
Salary: R55000 per month
Purpose of position
As a Clinical Country Study Manager, you will be responsible for providing leadership and regional/ local strategic planning and operational delivery of assigned clinical studies through all the phases of study management (Preparation, study start-up, conduct, close-out), in accordance with quality standards, all applicable regulations, timelines and budget commitments.
Duties:
• Full accountability for all assigned studies at regional/country level (Global and local studies) including adherence to quality, timelines and budget.
• Leads local study teams, represents Country/Region Clinical Operation at the global meeting, and provides Global Teams with feedback from a local perspective.
• Coaches, and provides indirect line management support in partnership with the relevant line managers to in-house study team members (i.e. Study Start Up Specialist) by setting clear goals and expectations, monitoring performance, providing overall motivation, support, feedback and follow up to ensure team performance is fully optimized.
• Provides oversight, leadership and support to CRO staff (ie Clinical Research Associates and Clinical Trial Assistants) to ensure overall delivery at the country and site level (time, quality, and cost) and interfaces regularly with local Vendor Manager and CRO Management regarding feedback on CRO staff performance.
Requirements:
This challenging role requires the following qualification, experience and skills:
• University degree or equivalent; preferably in medical/science –related field.
• A minimum of 5 years’ experience in clinical research/development or related industry.
• Conceptualize and solve both complex and uncomplicated problems by making decisions that are aligned with results of in-depth analysis of available information.
• Leadership: developed through leading multi-functional matrix study teams through all stages of clinical studies would be preferable
• Project Management: including implementation of risk management plans and management of complex study budgets and resourcing plans
• Good knowledge of ICH GCP, quality standards related to study management.
• Clinical development experience on the operational aspects of conducting clinical studies including: vendor/CRO resource management, leading/working as part of a development team, implementing clinical development plans, risk management
• Personal Organisation: demonstrated ability to prioritize and manage multiple tasks, self-motivated and achievement driven as well as ability to influence and negotiate at all levels to achieve team delivery.
Recruiter: PCSES