Sr. CTM, FSP

Thermo Fisher Scientific•Wilmington, NC

3d•Onsite

About The Position

The Senior Clinical Trial Manager is accountable for delivering the final clinical deliverable—usually clean data from evaluable patients as specified in the study protocol—within the customer contract period. The role interprets data on complex issues and makes business decisions with support from line management. It ensures clinical deliverables meet customer expectations for time, quality, and cost, and helps maintain profitability by keeping clinical activity within contract scope through efficient clinical team management. The Senior Clinical Trial Manager typically works independently on projects of moderate to high complexity and may take on regional lead or Clinical Study Manager responsibilities. The role manages clinical operations and quality for allocated studies in compliance with ICH GCP; develops clinical tools and contributes to study planning documents; maintains Trial Master File sections; and may contribute to CRFs, consent templates, and other protocol-specific documents. The Senior Clinical Trial Manager collaborates with project managers, clinical teams, and other departments; leads team meetings; communicates study status; implements standardized monitoring processes; and oversees timely study-document archiving. The position monitors timelines, metrics, project performance, and contractual obligations; takes recovery actions when needed; reviews monitoring visit reports; and manages CRF collection and query resolution. It communicates with study sites, may coordinate study start-up and regulatory submissions, follows up on ethics committee questions, contributes to clinical activity forecasts, and manages clinical resources and assignments. For certain North American Government & Public Health Studies projects, the role may include limited line-management responsibilities. 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 relevant formal academic or vocational qualification.
Previous 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/or 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 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, such as ICH/GCP and FDA guidelines.
Strong computer skills, including use of automated systems and applications such as Outlook, Excel, and Word.
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, assume regional Lead CTM or Clinical Study Manager responsibilities, or take on process improvement, complex-program management, management, or project coordination duties.
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-related documents and ensure timely set-up, organization, content, and quality of relevant local and central Trial Master File sections.
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 at client meetings, including bid defense and hand-off meetings.
Collaborate with clinical team members and other departments to meet project deliverables.
Communicate regularly with the team 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 departmental 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 clinical trials to assess performance and ensure contractual obligations are met.
May 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.
May coordinate study start-up activities, ensure essential-document quality meets Regulatory Compliance Review expectations, address timely regulatory submissions where appropriate, and review and follow up on ethics committee questions.
Provide input into clinical activity forecast estimates.
Manage clinical resources, assign and delegate clinical responsibilities, and identify additional resource needs.
May have limited line-management responsibilities when assigned to GPHS projects in North America.