Job Description: Clinical Team Manager (CTM)

Employment Type: Full-time Work Schedule: Standard (Mon-Fri) Location Type: Remote Environmental Conditions: Office

Position Overview

PPd (a part of Thermo Fisher Scientific) is seeking experienced Clinical Team Managers (CTMs) or Senior Clinical Team Managers (Snr CTMs) to join our Project Delivery team. This role is crucial for advising, coordinating, and managing the technical and operational aspects of clinical trials, ensuring their successful completion. We are looking for individuals with prior experience in respiratory, infectious disease, and/or critical care diseases (e.g., asthma, COPD, PAH, HIV, RSV, stroke).

As a CTM, you will leverage your deep knowledge, therapeutic expertise, and robust tools to help clients deliver life-changing therapies to market. You will take ownership, anticipate problems, find solutions, and deliver results by coordinating the activities of Clinical Management members on a regional or country basis. You will partner with the Project Manager to ensure vital training, tracking, and quality systems are in place for the clinical management team and be primarily responsible for the clinical results of the Project within agreed timelines and budget. CTMs also provide contact and support to the project sponsor for all clinical aspects.

PPd is committed to hiring the best, developing ourselves and each other, and recognizing the power of being one team. We offer continued career advancement opportunities, award-winning training, and benefits focused on the health and well-being of our employees.

Summarized Purpose

The CTM is accountable for achieving the final clinical result (usually clean data from evaluable patients as specified in the study protocol) within the time period specified in the contract with the customer. This role involves interpreting data on complex issues, making sound business decisions with support from line management, and ensuring all clinical results meet the customer's time, quality, and cost expectations. The CTM maintains profitability by ensuring clinical activity is conducted within contract scope through efficient management of the clinical team. Typically, the CTM works independently on projects of moderate to high complexity and may assume regional lead or Clinical Study Manager responsibilities.

Responsibilities

• Lead Clinical Operations: Lead all clinical operational and quality aspects of allocated studies, of moderate to high complexity, in compliance with ICH GCP.
• Assume Lead Roles: In accordance with project-specific requirements, may assume Lead CTM responsibilities on a regional level, Clinical Study Manager (CSM) responsibilities, or seek additional responsibilities such as process improvements, leading complex programs, or broader management/project coordination.
• Develop Clinical Tools: Develop clinical tools, such as Monitoring Plans and Monitoring Guidelines, in conjunction with the Data Quality Plan.
• Contribute to Master Action Plan (MAP): Contribute to the development of the MAP for providing clinical-related documents.
• Manage Trial Master File (TMF): Ensure timely setup, organization, content, and quality of the relevant sections of the Trial Master File (local and central).
• Document Development: May participate in the design and development of CRFs, CRF guidelines, patient informed consent templates, and other protocol-specific documents as required.
• Client Meeting Preparation: Collaborate with the project manager to prepare, organize, and present at client meetings, including bid defense and hand-off meetings.
• Cross-functional Collaboration: Collaborate with the clinical team and other departments as needed.

Requirements

• Prior experience as a Clinical Team Manager (CTM) or Senior Clinical Team Manager (Snr CTM).
• Good prior experience with respiratory, infectious disease, and/or critical care diseases (e.g., asthma, COPD, PAH, HIV, RSV, stroke).
• Ability to work independently on projects of moderate to high complexity.
• Knowledge of ICH GCP compliance.

Company Information

PPd, a part of Thermo Fisher Scientific, is dedicated to improving health by bringing life-saving therapies from idea to reality. We foster a collaborative environment where dedicated, forward-thinking, and energetic teams work together to reimagine health-promoting protocols.