Senior CTM, Hematology/Oncology

ThermoFisher Scientific; España; A distancia; EUR 85.000 - 120.000; Jornada completa

Descripción de la vacante

Thermo Fisher Scientific is seeking a Senior Clinical Team Manager to lead its Hematology/Oncology CTM group. You will manage clinical operations, ensure quality, and deliver study milestones within contract scope.

The role requires experience with multiple cancer indications and collaboration across cross-functional teams. Ideal candidates bring regional/global CTM experience, strong leadership, planning, and communication skills, and the ability to work in a matrixed organization.

Formación

• Bachelor's degree or equivalent is required.
• 5+ years of relevant experience is expected.
• Equivalency of education/training with related experience may be considered.

Responsabilidades

• Manage clinical operations and quality aspects of allocated studies per ICH GCP.
• Develop clinical tools and contribute to Master Action Plan for clinical documents.
• Coordinate start-up activities and regulatory submissions as appropriate.
• Lead team meetings and ensure timelines, resources, and quality are maintained.
• Monitor trials and manage CRF collection and query resolution.
• Ensure final deliverables meet time/quality/cost expectations.

Conocimientos

Leadership

Mentoring

Team motivation

Planning

Organization

Communication

Problem solving

English proficiency

Educación

Bachelor's degree or equivalent

Equivalent education/training/experience

Herramientas

Outlook

Excel

Word

Descripción del empleo

Work Schedule

Standard (Mon-Fri)

Environmental Conditions

Office

Job Description

Join us as a Senior Clinical Team Manager within the Hematology/Oncology team - Make an Impact at the Forefront of Innovation

The Senior Clinical Team 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.

We are seeking experienced Clinical Team Managers (CTMs) to join our growing Hematology/Oncology team. Ideal candidates will bring regional and/or global CTM experience, along with expertise in one or more of the following therapeutic areas and indications:

• Ovarian Cancer
• Sickle Cell Disease
• Non-Hodgkin Lymphoma
• Acute Myeloid Leukemia (AML)
• Glioma
• Head & Neck Cancer
• Pancreatic Cancer
• Prostate Cancer
• Non-Small Cell Lung Cancer (NSCLC)
• Breast Cancer
• Colorectal Cancer
• Experience with Radiopharmaceuticals, Cell & Gene Therapy, and CAR-T therapies is highly desirable.

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 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?

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.

We are unable to consider junior CTMs at this time.

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.