인재풀 - Clinical Trial Manager

Thermo Fisher Scientific · Remote

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Job Description

This is an evergreen (ongoing) talent pool position. Applications will be reviewed on a rolling basis, and qualified candidates may be considered with priority for relevant open roles as they arise. Please note that this posting does not correspond to a specific immediate vacancy, and only shortlisted candidates will be contacted; individual application status updates (including rejection notifications) may not be provided.

Join Us as a Clinical Trial Manager - Make an Impact at the Forefront of Innovation

The Clinical Trial Manager is accountable for achieving the final clinical deliverable (usually clean data from evaluable patients as specified in the study protocol) within the time period specified in the contract with the customer. The Clinical Trial Manager interprets data on project issues and makes good business decisions with support from experienced 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. The position involves working on projects of low to moderate complexity and as part of a team of CTMs.
What You'll Do:

• Manage 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 complex projects.
• Develop clinical tools (e.g. Monitoring Plan, Monitoring Guidelines) in conjunction with the Data Quality Plan. Contribute to the development of the Master Action Plan (MAP) for providing clinical related documents. Ensure 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 required. Collaborate with the project manager to prepare, organize, and present at client meetings, including bid defense and hand-off meetings.
• Collaborate with the clinical team and other departments as needed to meet deliverables of the project. Regularly communicate with the team and lead 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.
• Ensure achievement of the final clinical deliverable within the contractual time period specified by preparing and monitoring clinical activity timelines and metrics, providing status updates to the project manager, regularly reviewing projects using tracking and management tools, implementing recovery actions, reviewing monitoring visit reports, and managing CRF collection and query resolution. Continuously monitor 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 communicate 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. Ensure that essential document quality meets the expectation of Regulatory Compliance Review. Review 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 requirements.

Education & Experience Requirements:

• 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).

In some cases an equivalency, consisting of a combination of appropriate education, training and/or directly related experience, will be considered sufficient for an individual to meet the requirements of the role.
Knowledge, Skills, Abilities:

• Good leadership skills, effective at mentoring and training, and capable of motivating and integrating teams
• Good planning and organizational skills to enable effective prioritization of workload
• Solid interpersonal and problem solving skills to enable working in a multicultural matrix organization
• Capable of working effectively in a changing environment with complex/ambiguous situations
• Familiarity with the practices, processes, and requirements of clinical monitoring
• Good judgment and decision making skills
• Effective oral and written communication skills, including English language proficiency
• Capable of evaluating workload against project budget and adjusting resources accordingly
• Sound financial acument and knowledge of budgeting, forecasting and fiscal management
• Strong attention to detail
• Solid understanding of relevant regulations e.g. ICH/GCP, FDA guidelines, etc.
• Good computer skills to effectively use automated systems and computerized applications such as Outlook, Excel, Word, etc.

「인재풀 등록 시 고지 및 동의에 관한 안내」

귀하께서 인재풀에 등록하실 경우, 당사는 『개인정보 보호법』 제15조 및 제22조에 따라, 아래와 같은 목적을 위하여 귀하의 개인정보를 수집·이용할 수 있으며,
이에는 채용 관련 정보 제공 및 뉴스레터 발송이 포함됩니다.

• 수집·이용 목적: 채용 기회 안내, 채용 뉴스레터 발송, 향후 채용 포지션에 대한 적합 후보자 선정

• 수집 항목: 성명, 연락처, 이메일 주소, 경력 및 이력 정보 등 인재풀 등록 시 제공한 정보

• 보유·이용 기간: 인재풀 유지 기간 또는 수신 거부 요청 시까지

• 수신 동의: 인재풀 등록 완료 시, 위와 같은 정보 제공에 사전 동의하신 것으로 간주되며, 언제든지 수신 거부 및 정보 삭제 요청이 가능합니다.

수신을 원하지 않으실 경우, 등록 후 제공되는 ‘수신 거부’ 절차를 통해 변경하실 수 있습니다.

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