CTM/Sr CTM - FSP - EMEA

Role Overview

What You'll Do

• Manage all clinical operational and quality aspects of allocated studies in compliance with ICH GCP.
• Develop clinical tools such as Monitoring Plan and Monitoring Guidelines in conjunction with the Data Quality Plan.
• Ensure timely setup, organization, content, and quality of relevant sections of the Trial Master File.
• Collaborate with the project manager to prepare, organize, and present at client meetings including bid defense and hand-off meetings.
• Communicate with the clinical team and lead team meetings to maintain timelines, resources, interactions, and quality.
• Implement and train standardized clinical monitoring processes within the study.
• Prepare and monitor clinical activity timelines and metrics, provide status updates, and implement recovery actions.
• Review monitoring visit reports and manage CRF collection and query resolution.
• Continuously monitor or co-monitor clinical trials to assess performance and ensure contractual obligations are met.
• May coordinate start-up activities and ensure timely ethics committee and regulatory submissions.
• May provide input into preparation of forecast estimates for clinical activities and manage clinical resource assignment.

Education & Experience Requirements

• Bachelor's degree or equivalent and relevant formal academic or vocational qualification.
• Previous experience that provides the knowledge, skills, and abilities to perform the job, comparable to 5+ years.
• In some cases an equivalency of education, training, and directly related experience will be considered sufficient.

Knowledge, Skills, Abilities

• Good leadership skills, effective at mentoring and training, and capable of motivating and integrating teams.
• Good planning and organizational skills to enable effective prioritization of workload.
• Solid interpersonal and problem solving skills to enable working in a multicultural matrix organization.
• Capable of working effectively in a changing environment with complex or ambiguous situations.
• Familiarity with the practices, processes, and requirements of clinical monitoring.
• Good judgment and decision making skills.
• Effective oral and written communication skills, including English language proficiency.
• Capable of evaluating workload against project budget and adjusting resources accordingly.
• Sound financial acumen and knowledge of budgeting, forecasting, and fiscal management.
• Strong attention to detail.
• Solid understanding of relevant regulations such as ICH/GCP and FDA guidelines.
• Good computer skills to effectively use automated systems and applications such as Outlook, Excel, and Word.

Working Conditions and Environment

• Work is performed in an office environment with exposure to electrical office equipment.
• Frequently drives to site locations and frequently travels both domestic and international.
• Work schedule is standard, Monday through Friday.