Site Manager

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

📋 Description

• Oversee the execution of clinical studies

• Offer patient-related site assistance in line with study-specific management plans

• Enhance site staff utilization by providing training and supervision for complex logistical or technical study procedures

• Ensure the advancement of clinical studies while adhering to protocols, Ergomed SOPs, ICH GCP, and relevant regulatory standards

• Serve as the main point of contact for Study Site Coordinators and Research Nurses

• Engage in Site Manager training sessions

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

• Aid in patient recruitment and retention initiatives while monitoring recruitment efforts

• Manage the inventory of investigational medicinal products and clinical trial supplies

• Coordinate logistics for sample shipments

• Inform LSM, CRA, CTM, or PM of any identified site issues

• Build and maintain relationships with site coordinators, research nurses, investigators, and sub-investigators

• Participate in internal team teleconferences and site management meetings

• Draft Site Management Visit reports following on-site or remote evaluations

• Ensure that visit reports, phone contact reports, and pertinent correspondence are appropriately filed in the eTMF

• Assist in managing patient travel and related expenses, calculation sheets, and site invoicing

⛳️ Requirements

• Possess a degree, preferably in medical/public health, or relevant equivalent professional experience

• Prior experience in site management or site support roles

• Familiarity with clinical trial protocols and site management procedures

• Understanding of Ergomed standard operating procedures (SOPs)

• Knowledge of ICH GCP and applicable regulatory guidelines

• Capability to assist with patient recruitment and retention strategies

• Skill in overseeing the inventory of investigational medicinal products (IMP) and clinical trial supplies

• Proficiency in preparing site management visit reports, phone contact reports, and filing correspondence in the eTMF

• Ability to assist with patient travel expense management, calculation sheets, and site invoicing

• Capacity to collaborate effectively with Study Site Coordinators, Research Nurses, Investigators, and Sub-Investigators

🏝️ Benefits

• Flexibility for remote work

• Emphasis on work-life balance

• Opportunities for career advancement

• Collaborative environment within an international team

• Fulfilling work that supports patients

• A passionate and cooperative team of specialists

• An inclusive workplace where every opinion is valued