Clinical Team Manager / Sr. (Ctm) - Hemonc

Jobtome; Myrtle Point (OR); On-site; USD 90,000 - 130,000; Full time

Job summary

Thermo Fisher Scientific is seeking a Clinical Trial Manager to lead operational and quality aspects of low-to-moderate complexity studies in accordance with ICH GCP.

You will coordinate cross-functional teams, manage timelines and budgets, and ensure deliverables meet time/quality/cost expectations while maintaining contract scope. Remote work options are available; travel may be required.

Strong leadership, planning, and communication skills are essential in this global role.

Qualifications

• Bachelor's degree or equivalent in a related field.
• 5+ years of clinical research experience including trial operations, study management, or monitoring.
• FSO/CRO experience required.
• Global CTM experience managing cross-border teams.
• Indication experience in oncology or related therapies is a plus.

Responsibilities

• Manage clinical operational and quality aspects of low-to-moderate complexity studies in accordance with ICH GCP.
• Develop and implement clinical tools and master action plan with the project team.
• Coordinate with cross-functional teams to meet timelines and budget constraints.
• Monitor and report progress using timelines, metrics and CRF/CTF activities.
• Oversee start-up activities and regulatory submissions as appropriate.

Skills

Leadership

Project management

Team collaboration

Communication

Regulatory knowledge

Education

Bachelor's degree

Tools

MS Office

Job description

Work Schedule

Standard (Mon-Fri)

Environmental Conditions

Office

Job Description

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
• 5+ years of relevant experience in clinical research, including clinical trial operations, study management, clinical monitoring, or related clinical research activities.
• Transferable experience in healthcare, nursing, medicine, or related disciplines may be considered in combination with clinical trial experience where the candidate demonstrates significant clinical expertise, therapeutic area knowledge, and direct patient care responsibilities.
• Preferred candidates must have:
• Must have FSO/CRO experience.
• Must have Global CTM experience managing global teams.
• Indication experience: Ovarian, Sickle Cell, Non-Hodgkins Lymphoma, Multiple Myeloma, Glioma, Head and Neck, Pancreas, Prostate, Non-Small Cell Lung, Breast, Colorectal, Radiopharmaceutical, Cell and Gene Therapy, and/or CART-T.

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 acumen 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.

Working Conditions and Environment:

• Work is performed in an office environment with exposure to electrical office equipment.
• Frequently drives to site locations and frequently travels both domestic and international.

Why Join Us?

Before applying for this role, please read the following information about this opportunity found below.

When you join Thermo Fisher Scientific, you become part of a global team that values passion, innovation, and a commitment to scientific excellence. You'll work in an environment where collaboration and development are part of the everyday experience- and where your contributions truly make a difference.

Remote working/work at home options are available for this role.