Clinical Team Manager / Sr. (CTM) - HemOnc

Thermo Fisher Scientific•Morrisville, NC

2d•Onsite

About The Position

The Clinical Trial Manager is accountable for delivering the clinical results specified in the study protocol within the customer contract timeline and quality and cost expectations. The role interprets project data and issues, makes business decisions with support from experienced team members or a line manager, and maintains profitability by managing clinical activities within contract scope. The position supports projects of low to moderate complexity as part of a team of Clinical Trial Managers. The manager oversees clinical operations and quality in accordance with ICH GCP, develops study tools and contributes to clinical documents and Trial Master File quality, and collaborates with project managers, clinical teams, and other departments. The role monitors timelines, metrics, study performance, monitoring reports, CRF collection, and query resolution; implements recovery actions; and communicates project status. Depending on project needs, responsibilities may also include study start-up, regulatory and ethics submissions, site communications, clinical resource management, forecasting, financial oversight, and conducting accompanied field visits.

Requirements

Bachelor's degree or equivalent and relevant formal academic or vocational qualification.
At least 5 years of relevant clinical research experience, including clinical trial operations, study management, clinical monitoring, or related activities.
Must have FSO/CRO experience.
Must have global Clinical Trial Manager experience managing global teams.
Good leadership skills, including mentoring, training, motivating, and integrating teams.
Planning and organizational skills to prioritize workload effectively.
Interpersonal and problem-solving skills for working in a multicultural matrix organization.
Ability to work effectively in a changing environment and handle complex or ambiguous situations.
Familiarity with clinical monitoring practices, processes, and requirements.
Good judgment and decision-making skills.
Effective oral and written communication skills, including English proficiency.
Ability to evaluate workload against project budgets and adjust resources accordingly.
Financial acumen and knowledge of budgeting, forecasting, and fiscal management.
Strong attention to detail.
Understanding of relevant regulations, including ICH/GCP and FDA guidelines.
Computer skills to use automated systems and applications such as Outlook, Excel, and Word.
Transferable experience in healthcare, nursing, medicine, or related disciplines may be considered alongside clinical trial experience when the candidate demonstrates significant clinical expertise, therapeutic-area knowledge, and direct patient-care responsibilities.

Nice To Haves

Experience in one or more of these indications or modalities: ovarian cancer, sickle cell disease, non-Hodgkin lymphoma, multiple myeloma, glioma, head and neck cancer, pancreatic cancer, prostate cancer, non-small cell lung cancer, breast cancer, colorectal cancer, radiopharmaceuticals, cell and gene therapy, or CAR-T.

Responsibilities

Manage clinical operational and quality aspects of allocated low- to moderate-complexity studies in compliance with ICH GCP; may assume Clinical Study Manager responsibilities on small or less complex projects.
Develop clinical tools such as Monitoring Plans and Monitoring Guidelines in conjunction with the Data Quality Plan, and contribute to the Master Action Plan for clinical documents.
Ensure timely setup, organization, content, and quality of relevant local and central Trial Master File sections; may contribute to CRFs, CRF guidelines, informed consent templates, and other protocol-specific documents.
Collaborate with the project manager to prepare, organize, and present at client meetings, including bid defense and hand-off meetings.
Coordinate with the clinical team and other departments, communicate regularly, and lead team meetings to maintain timelines, resources, interactions, and quality.
Implement and train teams on standardized clinical monitoring processes and corporate policies; ensure timely archiving of departmental documents and study materials.
Prepare and monitor clinical activity timelines and metrics, provide status updates to the project manager, review projects using tracking and management tools, and implement recovery actions.
Review monitoring visit reports and manage CRF collection and query resolution; monitor or co-monitor clinical trials to assess performance and ensure contractual obligations are met.
In smaller regions, conduct Accompanied Field Visits and be accountable for project financials.
Communicate with study sites about protocol, patient participation, case report form completion, and other study-related issues, as needed.
Coordinate study start-up activities and ensure timely ethics committee and regulatory submissions, where appropriate; ensure essential document quality meets Regulatory Compliance Review expectations and follow up on ethics committee questions.
Provide input to clinical activity forecasts as needed; manage clinical resources, assign and delegate responsibilities, and identify additional resource needs.