Senior Clinical Project Manager

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

📋 Description

• Oversee and coordinate multifaceted clinical projects across clients in the pharmaceutical, biotechnology, medical device, and consumer health sectors.

• Manage project-specific Sponsor services such as central lab examinations, drug dispatches, and document shipments.

• Facilitate communication among Sponsors, Investigators, and project team members.

• Handle the documentation of study data, which includes CRFs, patient diaries, questionnaires, queries, study supplies, regulatory documents, and correspondence.

• Ensure adherence to project timelines and budgetary constraints.

• Monitor the workload and performance of the project team.

• Plan and oversee team assignments.

• Coordinate activities of Clinical Research Associates and Clinical Monitors.

• Collaborate on obtaining local authority approvals, as well as on biometrics, safety, regulatory, and archiving tasks.

• Support the Medical Monitor with developing protocols, Case Report Forms, and final Clinical Study Reports.

• Provide project-specific training and organize meetings for Monitors, Investigators, and project updates.

• Share project updates with Sponsors, Senior Project Managers, and Project Directors/Leaders.

• Raise issues to the Project Director/Leader as needed.

• Conduct co-monitoring visits when required.

• Mentor Project Coordinators and Project Manager I.

• Maintain relationships with Sponsors.

• Develop Standard Operating Procedures for clinical research activities and ensure compliance with Company protocols.

⛳️ Requirements

• A Bachelor's Degree or an equivalent University Degree in scientific, medical, or paramedical fields; equivalent education, training, or directly related experience may also be considered.

• Minimum of 8 years of clinical research experience in Project Management.

• Prior experience managing studies related to respiratory conditions, rare diseases, general medicines, and/or GLP-1 treatments.

• Experience working in a Contract Research Organization (CRO) is essential.

• Comprehensive understanding of clinical trial operations, GCP/ICH Guidelines, and relevant regulatory requirements.

• Proficient in English.

• Skilled in Microsoft Office, including Word, Excel, and Outlook.

• Previous experience as a Clinical Research Associate (CRA) is highly desirable.

• Familiarity with electronic data capture systems is preferred.

🏝️ Benefits

• Opportunities for professional development.

• Strong emphasis on work-life balance.

• A collaborative and quality-focused "one-team" culture.

• Ongoing training and close management support.

• Commitment to equal opportunity and an inclusive workplace.