Clinical Research Expert

vor 4 Wochen

Dortmund, Nordrhein-Westfalen, Deutschland Pharmiweb Vollzeit

Medical Monitor Role Overview

We are seeking an experienced Medical Monitor to join our team at Pharmiweb. As a Medical Monitor, you will be the clinical and scientific expert for trial protocols and Expanded Access Programs, ensuring the accuracy, quality, and compliance of clinical studies.

Key Responsibilities

  • Act as the main medical point of contact for investigators, regulatory bodies, and internal teams, clarifying protocols and ensuring consistent interpretation.
  • Oversee clinical trials and Expanded Access Programs to safeguard participant safety, data accuracy, and protocol adherence.
  • Address any medical issues arising during the study.
  • Organize and lead investigator calls to discuss eligibility criteria and enhance site selection and recruitment processes.
  • Conduct safety monitoring, including reviewing adverse events (AEs) and serious adverse events (SAEs), providing causality assessments, and ensuring timely reporting.
  • Collaborate with safety committees and Data Safety Monitoring Boards (DSMBs) to provide safety oversight and monitor ongoing trial data.
  • Deliver training to investigators and site staff on protocol and therapeutic area to ensure protocol adherence and comprehension.
  • Review protocol documents and provide expert medical input on study design, endpoints, and eligibility criteria.
  • Identify and resolve protocol deviations, maintaining the scientific integrity and ethical standards of the study.
  • Work closely with clinical, regulatory, and project management teams to ensure Good Clinical Practice (GCP) and regulatory compliance.
  • Support pharmacovigilance efforts to ensure safety reporting and manage safety signals throughout the trial.
  • Contribute to business development efforts, participating in project bid proposals and client meetings when requested.
  • Collaborate in cross-functional discussions, resolving protocol-related issues and aligning on trial objectives.

Requirements

  • MD or PhD in a health-related field is required.
  • Minimum of 5 years of experience in clinical research, with a focus on medical monitoring.
  • Familiarity with Expanded Access, Compassionate Use, or Named Patient Programs is advantageous.
  • Proven background in protocol development, implementation, and data interpretation.
  • Expertise in safety monitoring and adverse event reporting within clinical trial settings.
  • Solid knowledge of clinical trial design, regulatory standards, and drug development.
  • Proficient in Microsoft Office (Excel, Word, PowerPoint).
  • Strong leadership, communication, and collaboration skills, with an ability to engage effectively with diverse teams.
  • Analytical mindset with problem-solving capabilities, well-suited to the healthcare sector.
  • Ability to travel domestically and internationally up to 25%.

What We Offer

We're dedicated to creating a supportive work environment that values collaboration and empowers our employees. As part of our team, you'll engage in meaningful work that contributes to improving patient lives. We offer a competitive salary and benefits, including comprehensive health insurance, annual bonuses, a development allowance, pension schemes, flexible summer hours, and company social events.

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