Senior Clinical Trial Manager – Non-Interventional Studies

This is a fully remote position, open to applicants in Texas.

📋 Description

• Oversee all clinical operational and quality dimensions of assigned studies, which may vary in complexity from moderate to high, ensuring adherence to ICH GCP standards. Depending on project-specific needs, may take on Lead CTM roles at a regional level, Clinical Study Manager (CSM) tasks, or additional responsibilities such as process enhancements, management of intricate programs, and broader project coordination tasks.

• Create clinical tools (such as Monitoring Plan and Monitoring Guidelines) in collaboration with the Data Quality Plan. Contribute to the formulation of the Master Action Plan (MAP) for clinical documentation. Guarantee timely setup, organization, content accuracy, and quality of the pertinent sections of the Trial Master File (both local and central). May engage in designing and developing CRFs, CRF guidelines, patient informed consent templates, and other protocol-specific documents as necessary. Work closely with the project manager to prepare, organize, and present during client meetings, including bid defense and hand-off sessions.

• Work in partnership with the clinical team and other departments as required to achieve project deliverables. Maintain regular communication with the team and lead team meetings to ensure adherence to timelines, effective resource management, and high-quality standards. Responsible for implementing and training on standardized clinical monitoring practices within the study, adhering to corporate policies. Ensure timely archiving of documents and study materials for the department.

• Ensure the successful completion of the final clinical deliverable within the defined contractual timeline by preparing and monitoring clinical activity schedules and metrics, updating the project manager on status, routinely reviewing projects using tracking and management tools, executing recovery actions, assessing monitoring visit reports, and managing CRF collection and query resolution. Continuously evaluate clinical trials to assess performance and ensure all contractual obligations are fulfilled. May regularly conduct Accompanied Field Visits (AFVs) and oversee project financials.

• Interact with study sites regarding matters such as protocol adherence, patient involvement, case report form completion, and other study-related inquiries.

• May oversee all start-up activities, ensuring that the quality of essential documents meets Regulatory Compliance Review standards. Ensure that timely regulatory submissions (if applicable) are addressed. Review and respond to all questions raised by ethics committees. Responsibilities may vary based on project timelines.

• Provide insights for the preparation of forecast estimates related to clinical activities.

• Manage clinical resources, including the assignment and delegation of responsibilities, as well as identifying additional resource needs.

⛳️ Requirements

• Bachelor’s degree or equivalent with relevant formal academic or vocational qualifications.

• Prior experience that equips the individual with the knowledge, skills, and abilities necessary for the role (typically 8+ years).

• In certain cases, a combination of appropriate education, training, and/or directly related experience may be deemed sufficient to meet the role's requirements.

• Preferred experience: familiarity with STM roles and/or prior involvement in non-interventional / Phase IV studies / RWE studies.

• Strong leadership capabilities, proficient in mentoring and training, and skilled at motivating and integrating teams.

• Exceptional planning and organizational abilities to efficiently prioritize workload for oneself and team members.

• Strong interpersonal and problem-solving skills to effectively operate within a multicultural matrix organization.

• Solid grasp of change management principles.

• Comprehensive understanding of the practices, processes, and requirements related to clinical monitoring.

• Strong judgment, decision-making, escalation, and risk management skills.

• Effective oral and written communication skills, with proficiency in the English language.

• Able to assess personal and team workload in relation to project budget and adjust resources as necessary.

• Strong financial insight and knowledge of budgeting, forecasting, and fiscal management.

• Keen attention to detail.

• In-depth understanding of relevant regulations such as ICH/GCP, FDA guidelines, etc.

• Proficient computer skills to effectively utilize automated systems and applications such as Outlook, Excel, Word, etc.

• Capable of independently managing clinical-only studies.

🏝️ Benefits

• Health insurance

• 401(k) matching

• Flexible working hours

• Paid time off

• Remote work options