Sr. CTM, FSP

Thermo Fisher Scientific•Wilmington, NC

4d•Onsite

About The Position

The Senior 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 timeline defined in the customer contract. The role interprets complex data and makes business decisions with support from line management, while ensuring clinical deliverables meet customer expectations for time, quality, and cost and that clinical activities remain within contract scope and support profitability. The position typically manages moderately to highly complex projects independently and may take on regional lead or Clinical Study Manager responsibilities. The role manages clinical operations and quality in compliance with ICH GCP; develops clinical tools and contributes to study plans and documentation; coordinates clinical teams and cross-functional partners; monitors timelines, metrics, study performance, and contractual obligations; and communicates with study sites. Depending on project needs, responsibilities may also include study start-up and regulatory submissions, client meeting preparation, resource management, financial oversight, process improvement, and limited line management on certain North American Government & Public Health Studies projects. Work is performed in an office environment with exposure to electrical office equipment. The role frequently involves driving to site locations and domestic and international travel.

Requirements

Bachelor's degree or equivalent and a relevant formal academic or vocational qualification.
Experience providing the knowledge, skills, and abilities to perform the job, comparable to 8 or more years; an equivalent combination of appropriate education, training, and directly related experience may be considered.
Strong leadership skills, including mentoring, training, motivating, and integrating teams.
Strong planning and organizational skills for prioritizing personal and team workloads.
Strong interpersonal and problem-solving skills for working in a multicultural matrix organization.
Solid understanding of change management principles.
Comprehensive understanding of clinical monitoring practices, processes, and requirements.
Strong judgment, decision-making, escalation, and risk-management skills.
Effective oral and written communication skills, including English-language proficiency.
Ability to evaluate personal and team workloads against project budgets and adjust resources accordingly.
Strong financial acumen and knowledge of budgeting, forecasting, and fiscal management.
Strong attention to detail.
In-depth understanding of relevant regulations, including ICH/GCP and FDA guidelines.
Strong computer skills, including use of Outlook, Excel, Word, and other automated systems and computerized applications.
Ability to independently manage clinical-only studies.

Responsibilities

Manage clinical operational and quality aspects of allocated studies of moderate to high complexity in compliance with ICH GCP.
Depending on project requirements, serve as regional Lead CTM, Clinical Study Manager, or take on additional process improvement, program management, management, or project coordination responsibilities.
Develop clinical tools, such as Monitoring Plans and Monitoring Guidelines, in conjunction with the Data Quality Plan.
Contribute to the Master Action Plan for clinical documents and ensure timely set-up, organization, content, and quality of relevant local and central Trial Master File sections.
Participate as required in the design and development of CRFs, CRF guidelines, patient 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.
Collaborate with clinical team members and other departments to meet project deliverables; 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 documents and study materials for the department.
Deliver clinical outcomes within contractual timelines by preparing and monitoring clinical activity timelines and metrics, providing project status updates, reviewing projects with tracking and management tools, and implementing recovery actions.
Review monitoring visit reports and manage CRF collection and query resolution.
Continuously monitor trial performance and ensure contractual obligations are met; conduct Accompanied Field Visits when applicable and take accountability for project financials as required.
Communicate with study sites about protocol, patient participation, case report form completion, and other study-related issues.
Coordinate study start-up activities when assigned and ensure essential document quality meets Regulatory Compliance Review expectations.
Ensure timely regulatory submissions where appropriate and review and follow up on questions raised by ethics committees.
Provide input into clinical activity forecast estimates.
Manage clinical resources, assign and delegate clinical responsibilities, and identify additional resource requirements.
For assigned North American GPHS projects, potentially perform limited line management responsibilities.