Job Description

　　At Thermo Fisher Scientific, you'll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life - enabling our customers to make the world healthier, cleaner and safer. We provide our teams with the resources needed to achieve individual career goals while taking science a step beyond through research, development and delivery of life-changing therapies. With clinical trials conducted in 100+ countries and ongoing development of novel frameworks for clinical research through our PPD clinical research portfolio, our work spans laboratory, digital and decentralized clinical trial services. Your determination to deliver quality and accuracy will improve health outcomes that people and communities depend on - now and in the future.

　　Our global Clinical Operations colleagues within our PPD® clinical research services provide end-to-end support for clinical trials from study start up to monitoring through to study close out, across commercial and government contracts. Together, we help clients define and develop clinical programs, minimize delays, and execute high-quality, cost-efficient clinical studies.

　　Clinical Team Manager(CTM) to Sr.CTM

　　Location: Remote / Office / HybridType: Regular (정규직), Individual Contributor (no subordinators)Indication: Hematology and Oncology

　　Summarized Purpose:

　　Accountable for achieving the final clinical deliverable (usually clean data from valuable patients as specified in the study protocol) within the time period specified in the contract with the customer. Interprets data on project issues and makes good business decisions with support from expert team members or line manager. Works to ensure that all clinical deliverables meet the customer's time/quality/cost expectations. Maintains profitability by ensuring clinical activity is conducted within contract scope, through efficient management of the clinical team.

　　Key responsibilities:

　　Manages all clinical operational and quality aspects of allocated studies, of low to moderate complexity, in compliance with ICH GCP. In accordance to project specific requirements, may assume Clinical Study Manager (CSM) responsibilities on small and/or less sophisticated projects. Develops clinical tools (e.g. Supervising Plan, Monitoring Guidelines) in conjunction with the Data Quality Plan. Contributes to the development of the Master Action Plan (MAP) for providing clinical related documents. Ensures timely set up, organization, content and quality of the relevant sections of the Trial Master File (local and central). May participate in the design and development of CRFs, CRF guidelines, patient informed consent templates and other protocol specific documents as the need arises. Collaborates with the project manager to prepare, organize, and present at client meetings, including bid defense and hand-off meetings. Collaborates with the clinical team and other departments as needed to meet deliverables of the project. Regularly communicates with the team and leads team meetings to ensure that timelines, resources, interactions, and quality are maintained. Responsible for the implementation and training of standardized clinical monitoring processes within the study and according to corporate standard policies. Responsible for the timely archiving of documents and study materials for the department. Ensures achievement of the final clinical deliverable within the contractual time period specified by preparing and supervising clinical activity timelines and metrics, providing status updates to the project manager, regularly reviewing projects using tracking and management tools, implementing recovery actions, reviewing supervising visit reports, and managing CRF collection and query resolution. Continuously monitors or co-monitors clinical trials to assess performance and ensure contractual obligations are met. In smaller regions, may routinely conduct Accompanied Field Visits (AFVs) and be accountable for project financials. May connect with study sites regarding issues such as protocol, patient participation, case report form completion and other study-related issues. May coordinate all start-up activities and ensures that timely ethics committee and regulatory submissions (if appropriate) are addressed. Ensures that crucial document quality meets the expectation of Regulatory Compliance Review. Reviews and follows up on all questions raised by the ethics committees. May provide input into preparation of forecast estimates for clinical activities. Responsible for clinical resource management, assignment, delegation of clinical responsibilities and identification of additional resource requireme

　　Keys to Success

　　Bachelor's degree or equivalent and relevant formal academic / vocational qualification Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 5+ years). Effective oral and written communication skills, including English language proficiency Capable of evaluating workload against project budget and adjusting resources accordingly Solid understanding of relevant regulations e.g. ICH/GCP, FDA guidelines, etc.

　　기타사항

　　지원 과정에서 아래 사항에는 해당이 될 경우에만 Yes로 체크해주시기 바랍니다. - (1) 써모피셔 사이언티픽 과거 또는 현재 재직여부 (2) 합병 관계사 재직여부 (3) 장애여부(disabled) (4) 보훈대상여부(veteran) (5) VISA Sponsorship 지원 필요 여부 (6) U.S. 연방정부 기관 근무 여부 (7) 고용 및 이직에 제한사항 여부고유식별정보(주민등록번호, 여권번호 등) 민감정보(종교, 정치 등)는 기재하지 마세요.전형과정 중 합격 및 불합격 안내는 서류전형 합격자(인터뷰 대상자)에 한하여 개별 안내됩니다.보훈, 장애 대상자는 관련 서류 제출 시 관계법에 따라 우대합니다.영문이름은 여권상의 이름과 동일하게 기재하십시오.입사지원서 내용에 허위 사실이 판명될 경우, 입사가 취소될 수 있습니다.

　　• Our 4i Values:

　　Integrity - Innovation - Intensity - Involvement

　　• Our Mission:

　　Our Mission is to enable our customers to make the world healthier, cleaner and safer.

　　Our Mission is to enable our customers to make the world healthier, cleaner and safer. Watch as our colleagues explain 5 reasons to work with us. As one team of 100,000+ colleagues, we share a common set of values - Integrity, Intensity, Innovation and Involvement - working together to accelerate research, solve complex scientific challenges, drive technological innovation and support patients in need. #StartYourStory with PPD, part of Thermo Fisher Scientific, where diverse experiences, backgrounds and perspectives are valued.

　　Apply today! http://jobs.thermofisher.com

　　Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.