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Project manager- Clinical development

  • 채용정보

    Major Bio 기업

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    경력 7년 이상
    학력 대학교(4년)
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  • Project manager- Clinical development
업무내용
Project manager- Clinical development
The clinical operations team is responsible for the ution of all Phase 1-3 clinical trials, across
all therapeutic areas. Working with other departments/functions, clinical operations ensures that
all clinical trial activities are performed in accordance with regulatory guidelines to provide timely
delivery of high-quality clinical data to support the registration and commercialization of the
products.
Locations: Pangyo, Korea or, USA
Job Descriptions
 Manages global Phases I-III outsourced studies.
 Drafts and coordinates review of relevant documents including protocols, informed
consents, case report forms, monitoring plans, investigator brochures, and clinical study
reports.
 Manages study timelines.
 Contributes to development of study budget.
 Contributes to development of RFPs and participate in selection of CROs/vendors.
 Manages CROs/vendors.
 Coordinates review of data listings and preparation of interim/final clinical study
reports.
 Ensures effectiveness of site budget/contract process.
 May be asked to train CROs, vendors, investigators, and study coordinators on study
requirements.
 Conducts oversight monitoring visits of CRO or study sites as required.
 Interacts with cross-functional teams internally and externally to ensure trial progress.
Clinical Trial Project General Manager or Director
Qualifications:

 Knowledge of the drug development process with 6 plus years and a Ph.D. in a scientific
field or a PharmD, DVM, or MD degree.
 A minimum of 5 years of Clinical Project Management and/or Clinical
Operations experience at a Sponsor or CRO, preferably in hematology/oncology or a MS
or MBA.
 Experience should include 5 years of participation in cross functional project management
in various stages of development.
 Project Management Certification: PMP or equivalent is desirable, with working
knowledge of associated methodologies and principles.
 Solid understanding of applicable clinical research and scientific concepts and regulatory
requirements.
 Excellent communication skills both verbal and written are required Fluent in English and
Korean, preferred.
 Strong problem-solving skills with the ability to focus on time-sensitive objectives and
proven flexibility adapting to a rapidly evolving workload.
 Excellent IT skills, particularly MS Office Excel, Word, Project and ability to track
costs/budgets/financial reporting relating to project ution.
 Able to communicate and work with cross functional team, internally and externally.
Clinical Trial Project Management Position
Preferred experience, knowledge and skills:
 Educated to degree level or above within a scientific discipline. (Ph.D. preferred)
 Oncology experience is highly desired.
 Must have clinical trials experience including study management/coordination.
 Monitoring experience highly desirable as site oversight monitoring visits will be
required.
 Thorough knowledge and understanding of FDA and EU Regulations, ICH Guidelines, and
GCPs governing the conduct of clinical trials is desirable.
 Must be able to generally understand, interpret, and explain protocol requirements to
others.
 Ability to participate in multiple departmental or interdepartmental strategic initiatives
under limited supervision.
 Must have a general, functional expertise to support SOP development and
implementation.
 Self-motivated, assertive and able to function independently or as part of a team.
 Effective in selection of investigative sites, CROs, and vendors and management of
external resources.
 Strong interpersonal and negotiation skills as well as strong verbal and written
communication (including presentation of materials to internal teams and external
partners).
 Proven problem solving and decision-making skills and must be able to work under
minimal and at times no supervision, determine personal work plan, and schedule tasks
and activities.
 Ability and willingness to travel 10-20% (domestic and international).

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Project manager- Clinical development
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