Senior CTM – Internal Medicine, Dermatology, Cardiovascular, Liver, Nephrology, Immunology, Rare Disease, Diabetes

This is a fully remote position, open to applicants in Bulgaria, +4 more states.

📋 Description

• Oversee all clinical and start-up operations, as well as quality aspects of assigned moderate- to high-complexity studies, ensuring adherence to ICH GCP standards.

• Create start-up and clinical tools, such as Essential Document Checklists, Monitoring Plans, and Monitoring Guidelines.

• Assist in the development of the Master Action Plan for clinical-related documentation.

• Guarantee timely setup, organization, content, and quality of the relevant sections of the Trial Master File.

• Engage in the design and development of CRFs, CRF guidelines, informed consent templates, and protocol-specific documents.

• Work alongside the Project Manager to prepare, organize, and deliver presentations for client meetings, including bid defense and hand-off sessions.

• Collaborate with country start-up, regulatory, clinical, and other departments to achieve project goals.

• Maintain regular communication with teams and lead team meetings to uphold timelines, resources, interactions, and quality standards.

• Implement and train personnel on standardized clinical monitoring processes in line with corporate policies.

• Archive documents and study materials promptly.

• Track start-up and clinical timelines and metrics, provide status updates, execute recovery actions, review monitoring visit reports, and manage CRF collection and query resolution.

• Continuously assess clinical trials to evaluate performance and fulfill contractual obligations.

• Conduct Accompanied Field Visits and manage project financials as necessary.

• Liaise with study sites regarding protocols, patient participation, case report forms, and study-related issues.

• Coordinate start-up activities and ensure the quality of essential documents meets Regulatory Compliance Review standards.

• Ensure timely regulatory submissions and follow up on inquiries from ethics committees.

• Provide insights for forecast estimates related to start-up and clinical activities.

• Manage start-up and clinical resources, delegate tasks, and identify additional resource needs.

• Support sponsors on all clinical facets of projects.

• Collaborate with the Project Manager to ensure that training, tracking, and quality systems are effectively implemented.

⛳️ Requirements

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

• A minimum of 5 years of prior experience that provides the knowledge, skills, and abilities necessary for the role.

• An equivalent combination of suitable education, training, and/or directly related experience may also be considered.

• Strong leadership, mentoring, and training capabilities.

• Excellent planning and organizational abilities.

• Strong interpersonal and problem-solving skills in a multicultural matrix environment.

• Solid understanding of change management principles.

• Comprehensive knowledge of start-up and clinical monitoring practices, processes, and requirements.

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

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

• Ability to assess workload against project budgets and adjust resources accordingly.

• Strong financial understanding and expertise in budgeting, forecasting, and fiscal management.

• High attention to detail.

• In-depth knowledge of relevant regulations, including ICH/GCP and FDA guidelines.

• Proficient in computer skills, including Outlook, Excel, Word, and other computerized applications.

• Capability to independently manage clinical-only studies.

• Ability to work under pressure while prioritizing and managing multiple projects.

• Willingness to travel independently up to 20% by automobile, airplane, and train.

• Junior CTMs are not eligible for consideration.

🏝️ Benefits

• Opportunities for continued career advancement.

• Award-winning training programs.

• Benefits designed to promote the health and well-being of employees.

• Reasonable accommodations available to participate in the job application or interview process, perform essential job functions, and access employment benefits and privileges.