Site Manager – Clinical Research, Local Site Coordinator

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

📋 Description

• Facilitate the execution of clinical studies.

• Provide site support related to patients in accordance with specific site management plans for each study.

• Enhance the utilization of site personnel through training and oversight of logistically or technically challenging study procedures.

• Ensure that clinical studies are advanced and executed, documented, and reported in compliance with protocols, SOPs, ICH GCP, and regulatory standards.

• Serve as the primary liaison for Study Site Coordinators and Research Nurses.

• Engage in Site Manager training.

• Offer ongoing training, consultation, support, and supervision to Study Site Coordinators.

• Assist in strategies for patient recruitment and retention while monitoring recruitment activities.

• Oversee the inventory of investigational medicinal products and clinical trial supplies.

• Facilitate the logistics of sample shipments.

• Inform the LSM, CRA, CTM, or PM about any site-related issues.

• Maintain relationships with site coordinators, research nurses, investigators, and sub-investigators.

• Participate in internal team teleconferences and site management meetings.

• Prepare Site Management Visit reports following onsite or remote visits.

• Ensure that visit reports, phone contact reports, and correspondence are properly filed in the eTMF.

• Support the management of patient travel expenses, calculation sheets, and site invoicing.

⛳️ Requirements

• Educated to degree level, ideally in a medical or public health discipline, or possess relevant equivalent work experience.

• Prior experience in conducting site management or site support activities.

• Proficient in both English and German.

• Strong communication skills.

• Excellent organizational abilities.

• Familiarity with clinical study protocols, Ergomed SOPs, ICH GCP, and pertinent regulatory requirements.

• Capability to support study site coordinators, research nurses, investigators, and sub-investigators.

• Competence in managing the inventory of investigational medicinal products and clinical trial supplies.

• Skill in preparing site management visit reports and maintaining eTMF documentation.

• Ability to assist in patient travel expense management and site invoicing.

🏝️ Benefits

• Flexible remote working options.

• Emphasis on work-life balance.

• Collaborative environment with an international team.

• Opportunities for career advancement.

• Empowerment and autonomy in your role.

• Supportive workplace culture.

• Chance to contribute to impactful clinical research that aids in delivering safe and effective pharmaceutical treatments to patients.