벤처(코스닥상장사) CPM (Clinical Project Manager)
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CPM (Clinical Project Manager)
[담당업무]
- Manage overall clinical projects from initiation, organization of project team, conduct of clinical project, delivery of outcomes including CSR, timely and in compliance with applicable regulations.
- Oversee performance of CROs, third party vendors, and field CRAs including monitoring, to ensure compliance with study protocol and in accordance with scope of work and in accordance with
corporate timelines; identify areas of concern and escalate to CMO or CRO as appropriate.
- Provides guidance, clinical trial management expertise, and direction to contract CRAs in the field and inhouse staff.
- Assurance of regulatory compliance of investigational sites with company SOPs, EMA/FDA and ICH guidelines.
- Review key study quality metrics (e.g., eligibility, primary endpoint data, etc.) and determine appropriate action in conjunction with study team (autonomy may vary with experience).
- Investigational product(IP) accountability and reconciliation process.
- Manage conjunction with study team(autonomy may vary with experience).
- Responsible for review or approval of IP release packages.
- Oversee investigator meetings.
- Develop and administer study budgets.
- Review and/or submission of research ethics committee/regulatory documentation.
[지원자격]
- Background Education & Qualification Requirements Typical requires a BS or BA in a relevant scientific discipline and minimum 5 years
relevant clinical experience in the pharmaceutical industry or academia
- Knowledges in local regulations and ICH-GCP guidelines regarding clinical trials.
- Excellent interpersonal skills, ability to lead multifunctional teams, and mentor junior staff.
- Effectively solves problems and uses judgment relating to national and international regulations,
guidelines, investigator interactions and timelines.
- Must possess a proven ability to successfully develop, implement, manage and complete clinical trials and manage vendor relations.
- Must possess a proven ability to effectively communicate scientific, medical and organizational concepts to internal and external customers.
- Experience in selection and management of CROs/vendors and management of external resources.
- Good/excellent communication skill in English.
[담당업무]
- Manage overall clinical projects from initiation, organization of project team, conduct of clinical project, delivery of outcomes including CSR, timely and in compliance with applicable regulations.
- Oversee performance of CROs, third party vendors, and field CRAs including monitoring, to ensure compliance with study protocol and in accordance with scope of work and in accordance with
corporate timelines; identify areas of concern and escalate to CMO or CRO as appropriate.
- Provides guidance, clinical trial management expertise, and direction to contract CRAs in the field and inhouse staff.
- Assurance of regulatory compliance of investigational sites with company SOPs, EMA/FDA and ICH guidelines.
- Review key study quality metrics (e.g., eligibility, primary endpoint data, etc.) and determine appropriate action in conjunction with study team (autonomy may vary with experience).
- Investigational product(IP) accountability and reconciliation process.
- Manage conjunction with study team(autonomy may vary with experience).
- Responsible for review or approval of IP release packages.
- Oversee investigator meetings.
- Develop and administer study budgets.
- Review and/or submission of research ethics committee/regulatory documentation.
[지원자격]
- Background Education & Qualification Requirements Typical requires a BS or BA in a relevant scientific discipline and minimum 5 years
relevant clinical experience in the pharmaceutical industry or academia
- Knowledges in local regulations and ICH-GCP guidelines regarding clinical trials.
- Excellent interpersonal skills, ability to lead multifunctional teams, and mentor junior staff.
- Effectively solves problems and uses judgment relating to national and international regulations,
guidelines, investigator interactions and timelines.
- Must possess a proven ability to successfully develop, implement, manage and complete clinical trials and manage vendor relations.
- Must possess a proven ability to effectively communicate scientific, medical and organizational concepts to internal and external customers.
- Experience in selection and management of CROs/vendors and management of external resources.
- Good/excellent communication skill in English.
