Senior Clinical Trial Manager – Clinical Research Medical Advisor, M.D / PhD

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

📋 Description

• Deliver medical and scientific leadership to ensure the successful execution of clinical trials and studies within the designated country or region.

• Oversee the local clinical and medical components of trial implementation, which includes protocol evaluation, site selection assistance, feasibility assessments, and planning recruitment strategies.

• Serve as the medical representative for study design, regulatory communications, site training, protocol compliance, and patient safety.

• Recognize recruitment and operational obstacles and formulate mitigation strategies.

• Offer training on protocols, compounds, and indications to both internal and external partners.

• Contribute medical insights for informed consent documents and safety reporting.

• Collaborate with clinical operations, regulatory affairs, medical affairs, and external experts to enhance trial execution.

• Review serious adverse events, provide pharmacovigilance support, and guarantee the quality of clinical data.

• Assess study feasibility and assist in site engagement and training during the initial trial start-up phase.

• Ensure compliance with Good Clinical Practice, ICH guidelines, and local regulations.

• Participate in scientific discussions, advisory boards, and investigator meetings.

• Offer clinical and medical expertise during regulatory inspections, audits, and in trial documentation.

• May involve cross-country collaboration.

⛳️ Requirements

• An advanced scientific degree such as M.D., Ph.D., or Pharm.D. (M.D. is preferred); subspecialty training is advantageous.

• Fluency in the local language is essential.

• Proficiency in English, both spoken and written.

• A minimum of 3 years of experience in clinical development or clinical practice within the pharmaceutical or healthcare industry.

• A solid understanding of clinical trial design, execution, and ICH/GCP principles.

• Demonstrated ability to analyze intricate clinical and scientific issues and provide effective solutions.

• Strong communication and leadership abilities to collaborate across functions.

• A problem-solving attitude and adaptability across various therapeutic areas.

• Exceptional presentation skills in both English and the local language.

• Proficient in protocol review and feasibility assessment.

• Knowledge of safety and regulatory standards in clinical trials.

• Experience in supporting regulatory submissions, audits, and inspections.

• Willingness to travel up to 50% of the time.

🏝️ Benefits

• Opportunities for career development and advancement.

• Supportive and engaged management team.

• Training in technical and therapeutic areas.

• Recognition from peers.

• Comprehensive total rewards program.

• A culture of inclusivity.

• Reasonable accommodations provided when necessary.