Founded in 1997 by two Medical Doctors , Ergomed Plc is dedicated to the development of new drugs to save or improve lives. Operating with a global footprint in over 55 countries, Ergomed has the expertise to manage even the most challenging clinical trials.  Ergomed provides services to over 100 clients in a range of therapy areas but excels in the provision of services for  complex trials in Rare Diseases, Oncology and Neuroscience.

Brief summary of Responsibilities:

• The Clinical Team Manager will be responsible for operational project management and will act as the direct project line manager to allocated study Monitors.
•  The CTM proactively identifies, resolves/mitigates and escalates risks and/or issues to the PM/PD and Head of Clinical Operations as necessary
• Direct communication with project allocated Monitors, Site Managers and CTAs
• Direct communication and collaboration with the Sponsor representative in projects where only operational management is contracted, i.e. if no project manager  is assigned.
• Verifying and ensuring that project team members (Monitors, Site Managers, CTAs) are trained (e.g. GCP, SOP, indication, protocol, study specific procedures / requirements, etc. ) to perform their assignments
• Organizing and facilitating Monitors’ Meetings throughout the project. 
• Organizing and facilitating project team meetings (e.g. weekly calls with Monitors, Site Managers, CTAs), and ensuring meeting minutes are reviewed, approved and distributed to all concerned parties
• Developing, reviewing and revision of project documents (e.g. monitoring plan, CRF completion guidelines, study specific operating manual, study specific forms etc.)  
• Initiating corrective / preventative measures – e.g. update of study guidance documents, performing re-training, performing co-monitoring, etc.
• Investigator identification and selection,

Ops Technical Trainer (or Training Coordinator)

Position Summary: Training Coordinator (TC) will be responsible for the management of training, development and quality control of the Monitors and other staff performing monitoring tasks employed at ERGOMED and Monitors insourced from external vendors or Freelancers. The TC will work in close cooperation with the HR department and Line Managers for ensuring that new staff is properly trained for fulfilling their job. The TC will also be the first point of contact for PM/CTM or senior staff in case of any concerns about the training status or quality of the activities performed. The TC will assist and report to the Head of Investigational Site Services Department. On request of other Functional Heads and in agreement with the Head of Investigational Site Services the TC will take over similar activities as depicted above also for other operative staff, e.g. CTAs, SMs or CTMs.

• Developing, reviewing and revision of training related documents and development plans for Monitors, and if requested also for other operational staff
• Organizing and performing of training programs for monitors and other operational staff
• Performing and organizing routine/”for cause” Co-Monitoring visits at investigational sites with assigned monitors to assess Monitor’s performance
• Organizing, management and tracking of Co-Monitoring visits performed by other operational senior staff, such as PM, CTM or Senior Monitor
• Training of senior staff foreseen for performing Co-Monitoring or other quality control related procedures (e.g. QC of TMF, reviewing of Monitoring reports)
• Assisting HR department in training and alignment of activities of Line Managers of Monitors  or optimizing all relevant line manager processes
• Organizing the onboarding process of new monitors (and other operative staff if requested) in collaboration with the human resources department and the respective line manager
• Performing job interviews and skill assessments with operative staff candidates, in cooperation and on request by the HR department and/or the Head of Global PM and Monitoring
• Collaborating effectively with vendors providing Monitor resources to develop and implement training and development plan in a timely manner based on any deficiencies found or areas identified for improvement
• Setting up and Review of Ergomed SOPs within area of expertise, related Forms, other guidelines or plans as requested
• Assisting with in-house and on-site Site Monitoring inspection readiness activities, as requested
• Identifying ways to streamline work processes within the operative group and support quality improvement initiatives.
• Reviewing internal audit report observations and supporting PMs, CTM and Monitors to develop a plan for addressing actions, as requested.

·         Proven experience working within clinical operations  

·         Ability to line  manage study monitors/CRA’s

·         Experience of phase 2/3 trials ideally complex studies such as oncology or rare disease

·         Able to work in a fast paced small CRO  environment and manage multiple projects

·         A minimum of a science based Bachelors degree

·         Able to work effectively with minimal supervision

Why Should You Apply?

·         You want  be involved in a wide range of interesting projects and studies

·         You want your  achievements  and hard work to be recognized

·         You want to work for a growing company where you can progress in your career and where there are opportunities for advancement.

·         You want to work in a company that has a great reputation with its clients and employees, and invests in its relationships with both.