Clinical Trial Manager, FSP

Thermo Fisher Scientific•Wilmington, NC

2d•Onsite

About The Position

The Clinical Trial Manager is accountable for delivering the final clinical outcome—usually clean data from evaluable patients as specified in the study protocol—within the customer contract timeline. The role interprets project issues and makes business decisions with support from experienced team members or a line manager, while ensuring clinical deliverables meet customer expectations for time, quality, and cost. The Clinical Trial Manager maintains profitability by keeping clinical work within contract scope and efficiently managing the clinical team. The position works on low- to moderate-complexity projects as part of a team of Clinical Trial Managers. The role manages operational and quality aspects of allocated studies in compliance with ICH GCP, and may take on Clinical Study Manager responsibilities for small or less complex projects. It develops clinical tools and contributes to study plans and Trial Master File quality, coordinates with project teams and other departments, manages clinical timelines and metrics, and supports study-site communications and start-up activities as needed. The position may also contribute to clinical activity forecasts and manages clinical resources and delegated responsibilities. Work is performed in an office environment with exposure to electrical office equipment. The role frequently drives to site locations and travels domestically and internationally. Thermo Fisher Scientific describes its environment as collaborative, with opportunities for development and contributions to scientific excellence.

Requirements

Bachelor's degree or equivalent and relevant formal academic or vocational qualification.
Previous experience providing the knowledge, skills, and abilities to perform the job, comparable to 5 or more years; an appropriate combination of education, training, and directly related experience may be considered equivalent.
Good leadership skills, including mentoring, training, motivating, and integrating teams.
Planning and organizational skills to prioritize workload effectively.
Interpersonal and problem-solving skills for work in a multicultural matrix organization.
Ability to work effectively in a changing environment with 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 applicable regulations, including ICH/GCP and FDA guidelines.
Computer skills to use automated systems and applications such as Outlook, Excel, and Word.

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, including Monitoring Plans and Monitoring Guidelines, in conjunction with the Data Quality Plan; 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; participate in developing CRFs, CRF guidelines, informed consent templates, and other protocol-specific documents as needed.
Collaborate with the project manager to prepare, organize, and present at client meetings, including bid defense and hand-off meetings.
Collaborate across 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 in accordance with study requirements and corporate policies.
Ensure timely archiving of department documents and study materials.
Achieve clinical deliverables within contractual timelines by preparing and monitoring clinical activity timelines and metrics, providing status updates, reviewing projects with tracking and management tools, implementing recovery actions, reviewing monitoring visit reports, and managing CRF collection and query resolution.
Continuously 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 as applicable.
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 clinical responsibilities, and identify additional resource requirements.