Senior Clinical Trial Manager – CNS

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

📋 Description

• Provide leadership and guidance to the clinical site management team throughout the study lifecycle, from initiation to closure.

• Supervise regional Clinical Trial Managers (CTMs) and harmonize efforts within the CTM team.

• Represent Site Management matters during Sponsor, Investigator, and bid defense meetings.

• Serve as the primary point of contact for all activities throughout the study.

• Contribute to the comprehensive project plan and develop global monitoring strategies across designated regions.

• Assign sites on behalf of the sponsor.

• Assume a dual role of Project Manager (PM) and CTM when necessary.

• Create, maintain, and ensure adherence to Clinical Monitoring Plans, including budgets, study tools, and site visit reports.

• Review protocol deviations, out-of-scope items, and actionable items.

• Train and oversee Clinical Research Associate (CRA) teams on clinical study aspects.

• Engage in the development and execution of recruitment strategies.

• Anticipate site visits with CRA teams to meet staffing requirements and mitigate backlogs.

• Mentor CTMs as required.

• Conduct co-monitoring visits.

• Review and finalize trip reports in accordance with WCT Standard Operating Procedures (SOPs).

• Assist study teams during inspections by healthcare authorities or sponsor audits.

⛳️ Requirements

• Exceptional interpersonal, oral, and written communication skills in both English and the local language.

• Capacity to lead and inspire a remote team.

• Strong initiative and problem-solving abilities.

• Robust customer orientation with the capability to engage professionally with sponsor contacts.

• Proficient in Microsoft Office, Clinical Trial Management Systems (CTMS), and Electronic Data Capture (EDC) systems.

• Bachelor's degree or equivalent in biological, physical, or health studies, with a minimum of 4 years of experience as a Senior Clinical Research Associate or similar role.

• Alternatively, possess a two-year college degree or equivalent education/training along with a minimum of 6 years as a Senior Clinical Research Associate.

• At least 2 years of relevant experience as a CTM/LCRA or equivalent, including oversight of a CTM team.

• Experience in Neuroscience/Central Nervous System (CNS) studies is essential.

• Willingness to travel is required.

🏝️ Benefits

• Equal employment opportunities without regard to race, color, ethnicity, ancestry, religion, national origin, gender, sex, gender identity or expression, sexual orientation, age, citizenship, marital or parental status, disability, military status, or any other class protected by applicable law.

• A diverse and inclusive workplace culture.

• A supportive and team-oriented environment.

• Accessible and hands-on leadership.

• Equal opportunity for success.