Clinical Trial Manager, FSP

Thermo Fisher Scientific•Wilmington, NC

3d•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. The role interprets project issues and makes business decisions with support from experienced team members or a line manager. It ensures clinical deliverables meet customer expectations for time, quality, and cost, while maintaining profitability by managing clinical activities within contract scope and efficiently overseeing the clinical team. The position works on low- to moderate-complexity projects as part of a team of Clinical Trial Managers. The Clinical Trial Manager manages clinical operational and quality aspects of allocated studies in compliance with ICH GCP, and may assume Clinical Study Manager responsibilities for small or less complex projects. The role develops clinical tools and contributes to project plans and Trial Master File content; collaborates on study documents and client meetings; coordinates clinical teams and standardized monitoring processes; and monitors timelines, metrics, study performance, and deliverables. The position may also support site communications, study start-up and regulatory submissions, clinical activity forecasting, and clinical resource management.

Requirements

Bachelor's degree or equivalent and relevant formal academic or vocational qualification.
Comparable to 5+ years of previous experience providing the knowledge, skills, and abilities to perform the job; an appropriate combination of education, training, and/or directly related experience may be accepted as an equivalency.
Good leadership skills, including mentoring, training, motivating, and integrating teams.
Good planning and organizational skills, including effective workload prioritization.
Solid interpersonal and problem-solving skills for working 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.
Sound financial acumen and knowledge of budgeting, forecasting, and fiscal management.
Strong attention to detail.
Solid understanding of relevant regulations, such as ICH/GCP and FDA guidelines.
Good computer skills, including use of Outlook, Excel, Word, and similar automated systems and applications.

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-related documents.
Ensure timely setup, organization, content, and quality of relevant local and central Trial Master File sections; ensure timely archiving of documents and study materials.
Participate as needed in designing and developing CRFs, CRF guidelines, patient informed consent templates, and other protocol-specific documents.
Collaborate with the project manager to prepare, organize, and present client meetings, including bid defense and hand-off meetings.
Collaborate with the clinical team and other departments, communicate regularly, and lead team meetings to maintain project timelines, resources, interactions, and quality.
Implement and train teams on standardized clinical monitoring processes in accordance with study requirements and corporate policies.
Achieve clinical deliverables within contractual timelines by preparing and monitoring activity timelines and metrics, updating the project manager, reviewing project tracking tools, and implementing recovery actions.
Review monitoring visit reports and manage CRF collection and query resolution.
Continuously monitor or co-monitor clinical trials to assess performance and ensure contractual obligations are met; may conduct Accompanied Field Visits in smaller regions and be accountable for project financials.
Communicate with study sites as needed regarding protocol, patient participation, case report form completion, and other study-related issues.
Coordinate study start-up activities as needed 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 into clinical activity forecast estimates as needed.
Manage clinical resources, assign and delegate clinical responsibilities, and identify additional resource requirements.