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
Locations: Pangyo, Korea or, USA
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
Manages study timelines.
Contributes to development of study budget.
Contributes to development of RFPs and participate in selection of CROs/vendors.
Coordinates review of data listings and preparation of interim/final clinical study
Ensures effectiveness of site budget/contract process.
May be asked to train CROs, vendors, investigators, and study coordinators on study
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
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
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
Excellent communication skills both verbal and written are required Fluent in English and
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
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
Ability to participate in multiple departmental or interdepartmental strategic initiatives
under limited supervision.
Must have a general, functional expertise to support SOP development and
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
Strong interpersonal and negotiation skills as well as strong verbal and written
communication (including presentation of materials to internal teams and external
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
Ability and willingness to travel 10-20% (domestic and international).