외자사 CRO, Project Director
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Project Director
[담당업무]
1. Lead, supervise, execute, manage and monitor daily business operations and service performance to achieve financial goals and business growth objectives of responsible operations; PMs (including CPA(s) and CPS(s)) in Korea
2. Responsible for overseeing a number of Projects to ensure that all deliverables from the program are met and that the client is satisfied with the service delivery and results.
3. Responsible for the quality check of scientific documents according to the international medical and scientific document standards (e.g., ICH guidelines). Documents include Clinical Study Protocol, Informed Consent Form (ICF), Clinical Study Report (CSR), Post Marketing Surveillance (PMS) documents or publication manuscripts, etc.
4. Lead, manage and supervise in hiring, onboarding, performance evaluation, resourcing, talent retention and succession planning processes of PM department. Ensure appropriate utilization and delivery resource supply/demand balancing inclusive of talent attraction, talent placement, on-boarding and training within responsible operation functions; PMs (including CPA(s) and CPS(s))
5. Collaborate with stakeholders to develop, establish, execute, manage and supervise service quality standards and performance deliverables to ensure all policies, procedures, standards, specifications, guidelines, training programs and cultural values are in line with Company Group and CRO business unit. Champion and support the development and implementation of Quality Management System and GxP processes to lift up operations standards and performance excellence.
6. Oversee day-to-day operations, review tasks execution and performance status, and report to supervisor on matters related to Operations and Quality
7. Guide, resolve and improve internal and external conflicts, complaints and underperformance efficiently and to the mutual benefit of those involved. Ensure corrective and preventive actions are executed fully and timely
8. Collaborate with Company stakeholders to provide insights, recommendations, and assistance to develop strategies and operational plans towards continued business growth and profitability
9. Guard, control, carry out costs savings measures and develop improvement actions to meet or exceed budgetary and agreed performance targets to create a sustainable organization
10. Have a primary responsibility to manage PM resource and conduct regular 1:1 sessions with direct reports and the team meeting, identify areas for development and ensure that all trainings are effective and meeting the training and personal development objectives. Lead, act and supervise the implementation of trainings to ensure professional development and career advancement of the employees within responsible business operations
11. Take a responsibility to lead portfolio/ project as per resource availability in Korea
12. Demonstrate leadership by examples to create a stimulating, positive, energetic work atmosphere by adopting CAS “FOCUS Principles” with “CARE” – Communication, Appreciation, Respect and Empathy to foster a happy, harmony, caring and healthy workplace
13. Keep abreast of competitive regulatory and clinical practices and utilize such knowledge for continuous improvements. Understand evolving customer strategy and industry trends and how that changes may impact Company future service delivery needs. Ensure service offerings evolve in line with/ahead of customer evolving needs and expectations.
14. Respond to routine and non-routine inquiries and assignments in a timely and professional manner by the company
15. Support and lead business development activities as assigned
[지원자격]
- Minimum bachelor degree (major in nursing, pharmacy or other bio-science-related background) from a recognized institution, and/or equivalent combination of training and experience
- Minimum 13 years’ experience in clinical research in healthcare, pharmaceutical and/or CRO industry, or relevant experience
- minimum 5 years direct experience as clinical project manager in multi-national clinical trials and/or ICCC trials
- Has experience in a pharmaceutical/biotechnology setting including development of pharmaceutical products and/or medical equipment. Has in-depth knowledge/understanding of clinical development.
-Good understanding of cross-functional processes, clinical trial processes and the regulatory environment
-Good organizational, leadership, negotiation and interpersonal skills
-Excellent written and verbal communication skills, with good command of English in addition to local language
[담당업무]
1. Lead, supervise, execute, manage and monitor daily business operations and service performance to achieve financial goals and business growth objectives of responsible operations; PMs (including CPA(s) and CPS(s)) in Korea
2. Responsible for overseeing a number of Projects to ensure that all deliverables from the program are met and that the client is satisfied with the service delivery and results.
3. Responsible for the quality check of scientific documents according to the international medical and scientific document standards (e.g., ICH guidelines). Documents include Clinical Study Protocol, Informed Consent Form (ICF), Clinical Study Report (CSR), Post Marketing Surveillance (PMS) documents or publication manuscripts, etc.
4. Lead, manage and supervise in hiring, onboarding, performance evaluation, resourcing, talent retention and succession planning processes of PM department. Ensure appropriate utilization and delivery resource supply/demand balancing inclusive of talent attraction, talent placement, on-boarding and training within responsible operation functions; PMs (including CPA(s) and CPS(s))
5. Collaborate with stakeholders to develop, establish, execute, manage and supervise service quality standards and performance deliverables to ensure all policies, procedures, standards, specifications, guidelines, training programs and cultural values are in line with Company Group and CRO business unit. Champion and support the development and implementation of Quality Management System and GxP processes to lift up operations standards and performance excellence.
6. Oversee day-to-day operations, review tasks execution and performance status, and report to supervisor on matters related to Operations and Quality
7. Guide, resolve and improve internal and external conflicts, complaints and underperformance efficiently and to the mutual benefit of those involved. Ensure corrective and preventive actions are executed fully and timely
8. Collaborate with Company stakeholders to provide insights, recommendations, and assistance to develop strategies and operational plans towards continued business growth and profitability
9. Guard, control, carry out costs savings measures and develop improvement actions to meet or exceed budgetary and agreed performance targets to create a sustainable organization
10. Have a primary responsibility to manage PM resource and conduct regular 1:1 sessions with direct reports and the team meeting, identify areas for development and ensure that all trainings are effective and meeting the training and personal development objectives. Lead, act and supervise the implementation of trainings to ensure professional development and career advancement of the employees within responsible business operations
11. Take a responsibility to lead portfolio/ project as per resource availability in Korea
12. Demonstrate leadership by examples to create a stimulating, positive, energetic work atmosphere by adopting CAS “FOCUS Principles” with “CARE” – Communication, Appreciation, Respect and Empathy to foster a happy, harmony, caring and healthy workplace
13. Keep abreast of competitive regulatory and clinical practices and utilize such knowledge for continuous improvements. Understand evolving customer strategy and industry trends and how that changes may impact Company future service delivery needs. Ensure service offerings evolve in line with/ahead of customer evolving needs and expectations.
14. Respond to routine and non-routine inquiries and assignments in a timely and professional manner by the company
15. Support and lead business development activities as assigned
[지원자격]
- Minimum bachelor degree (major in nursing, pharmacy or other bio-science-related background) from a recognized institution, and/or equivalent combination of training and experience
- Minimum 13 years’ experience in clinical research in healthcare, pharmaceutical and/or CRO industry, or relevant experience
- minimum 5 years direct experience as clinical project manager in multi-national clinical trials and/or ICCC trials
- Has experience in a pharmaceutical/biotechnology setting including development of pharmaceutical products and/or medical equipment. Has in-depth knowledge/understanding of clinical development.
-Good understanding of cross-functional processes, clinical trial processes and the regulatory environment
-Good organizational, leadership, negotiation and interpersonal skills
-Excellent written and verbal communication skills, with good command of English in addition to local language
