Clinical Trial Manager / Sr. (CTM) - NIS (Non-Interventional Studies)

Thermo Fisher Scientific•Austin, TX

2d•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 timeframe specified in the customer contract. The role interprets complex issues and makes business decisions with support from line management. It ensures clinical deliverables meet customer expectations for time, quality, and cost, while maintaining profitability through efficient management of the clinical team and ensuring work remains within contract scope. The Senior Clinical Trial Manager typically works independently on moderately to highly complex projects and may take on regional lead or Clinical Study Manager responsibilities. The role manages clinical operational and quality aspects of allocated non-interventional studies in compliance with ICH GCP. Responsibilities may include developing clinical tools and study documents, maintaining Trial Master File sections, coordinating project and client meetings, leading clinical teams, monitoring timelines and study performance, managing clinical resources and financials, communicating with study sites, and supporting study start-up and regulatory submissions as appropriate. The position is based in an office environment and involves frequent travel to site locations, both domestically and internationally.

Requirements

Bachelor's degree or equivalent and a relevant formal academic or vocational qualification.
Previous experience providing the knowledge, skills, and abilities to perform the role, comparable to 8 or more years.
Strong leadership skills, including mentoring, training, motivating, and integrating teams.
Strong planning and organizational skills to prioritize personal and team workloads.
Strong interpersonal and problem-solving skills for work 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 assess personal and team workload 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 Outlook, Excel, Word, and other automated systems and 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.
As needed, take on regional Lead CTM, Clinical Study Manager, process improvement, complex 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 setup, organization, content, and quality of relevant local and central Trial Master File sections.
Participate as required 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 teams and other departments, lead team meetings, and communicate regularly 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 the final clinical deliverable within the contract timeframe by preparing and monitoring clinical activity timelines and metrics, providing status updates, reviewing projects with tracking 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; 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, and address timely regulatory submissions as appropriate.
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 GPHS projects in North America, may have limited line management responsibilities.