Clinical Trial Manager

This is a fully remote position, open to applicants in Poland, +4 more countries.

📋 Description

• Oversee and operationally implement clinical components within trials, encompassing site selection, initiation, enrollment management, site engagement and support, monitoring planning and execution, data cleaning, and closure.

• Successfully execute assigned trials and guarantee the fulfillment of trial deliverables.

• Ensure effective communication, appropriate regulatory documentation, and continuous oversight of assigned trials in partnership with functional team members.

• Provide mentorship and training to team members.

• Recognize potential challenges to study timelines and deliverables, and create innovative action plans for the team and sponsor.

• Guide Clinical Research Associates (CRAs) in building site relationships and managing monitoring, regulatory, investigational product, site payment, and site correspondence activities.

• Keep the team focused on study priorities through cross-functional collaborations and effective communication to ensure client satisfaction.

• Act as the central intelligence hub for managed studies and supervise clinical aspects across various countries.

⛳️ Requirements

• A Bachelor’s degree or an equivalent combination of education and experience in a science or health-related field, with experience in oncology.

• Proven experience leading clinical aspects of studies across multiple countries within a Contract Research Organization (CRO), Pharmaceutical, or Biotech firm in a dedicated clinical lead capacity.

• Extensive clinical trial management experience specifically in oncology.

• Solid understanding of Good Clinical Practice (GCP) and International Council for Harmonisation (ICH) guidelines, as well as the clinical development process.

• Willingness to travel domestically and internationally, including overnight stays.

• Proficient in English communication.

• Strong computer skills in Microsoft Office, Microsoft Project, and PowerPoint.

• Familiarity with Clinical Trial Management Systems (CTMS), Electronic Trial Master File (eTMF), Electronic Data Capture (EDC), and Interactive Voice Response Systems (IVRS).

• Proven ability to foster positive working relationships with internal and external organizations.

• Fundamental understanding of medical terminology and clinical trial activities related to the execution of a clinical development plan.

• Mastery of ICH-GCP, relevant Precision Standard Operating Procedures (SOPs), and regulatory guidance, with the capability to implement them.

• Candidates must be legally authorized to work in the country of employment without requiring employer sponsorship.

🏝️ Benefits

• Flexible remote work arrangement.

• Support for career growth and ongoing professional development.

• Opportunities for mentoring and training.

• Domestic and international travel opportunities.