For Current Gilead Employees and Contractors:
Please log onto your Internal Career Site to apply for this job.
At Gilead we believe every employee deserves a great leader. As a people leader now or in the future, we expect that you will model and create an environment of inclusion, be intentionally focused on the hiring, development, growth and retention of talent, and empower teams to align and achieve goals.
Job Description
The Sr. Clinical Trials Manager (CTM) is responsible for the execution of Korean PMS including NIS, across all therapeutic areas. In partnership with Clinical Research, Medical Affairs and other Development Operations functions, Sr. CTM ensures that all PMS activities are performed in accordance with applicable SOPs, company policies and regulatory guidelines to provide timely delivery of high-quality data to support product registration and commercialization of Gilead’s products.
For the team based in Seoul/Korea, we are looking for a Senior Clinical Trials Manager or Clinical Trials Manager depending on their experience level.
EXAMPLE RESPONSIBILITIES:
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Leads and oversees all components of assigned studies partnership/collaboration with Clinical Program Managers.
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Collaborates with other functions on how to best achieve their study goals and objectives and communicates cross-functionally to ensure project team goals are met.
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May lead contract research organization (CRO)and vendor selection and, where applicable,
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Oversees all interactions and deliverables from relevant CROs and vendors.
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Provides guidance and training to team members, CROs, vendors, and investigators on study requirements.
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Defines and develops the study logistics and plan for assigned PMS.
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Defines, develops, and oversees adherence to study timelines, including documentation and communications.
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May initiate, author, or otherwise contribute to SOP development and implementation.
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Participates in special projects.
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Presents at internal and external meetings.
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Provides input into study protocols and oversees the development of the content for all study plans and study documents.
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Ensures team’s work complies with established practices, policies, and processes, and any regulatory or other requirement.
REQUIREMENTS:
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We are all different, yet we all use our unique contributions to serve patients. Please see the following for the qualifications and skills we seek for this role.
Minimum Education & Experience
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10+ years’ relevant clinical, KR PMS or related experience in life sciences.
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Multiple years’ KR PMS, or related experience in life sciences, including multiple years’ experience leading studies and project teams.
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Demonstrated abilities to effectively lead and manage a project team and/or effectiveness coaching and mentoring less experienced colleagues.
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Works with Clinical Program Managers to manage processes of PMS and with latitude for independent judgment and decision-making within defined guidelines.
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Demonstrated success in managing members of the team and supporting their professional development.
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Excels in project management and demonstrates ability to take on more studies and/or studies of greater complexity by managing through others or delegation.
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Understands how the design and operations of PMS impact the goals of various functions.
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In partnership with CPMs, provides guidance and daily oversight for the successful management of all aspects of international clinical trials within designated program budgets and timelines.
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Contributes to development of study report, abstracts, presentations, and manuscripts.
Knowledge & Other Requirements
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Demonstrated ability to be a fast learner.
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Demonstrated ability to be flexible and adaptable to change, to move between projects easily and provide support/expertise where needed.
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Complete knowledge of full cycle study management, from start-up to close-out.
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Advanced knowledge of study management best practices and tools and has shown ability to apply these to improve study efficiencies and effectiveness.
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Fully understands protocol requirements and effectively articulates and interprets these.
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Significant industry knowledge, including knowledge of drug development.
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Thorough knowledge and understanding of local Regulations, ICH Guidelines, and GCPs governing the conduct of clinical trials is desirable
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Proven ability to effectively author clinical study and regulatory documentation.
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Ability to lead and influence programs, projects and/or initiatives.
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Strong interpersonal skills and understanding of team dynamics
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Proven ability to work successfully in a team-oriented, highly-matrixed environment.
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When needed, ability to travel.
For Current Gilead Employees and Contractors:
Please log onto your Internal Career Site to apply for this job.
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