.Company DescriptionFounded 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.
As part of the Ergomed Group, our joint mission is to become the leading global specialized CRO in Orphan Drugs.
Through different ways, we try to help these patients and make sure their voices are heard.Are you ready for a new career at a niche CRO?Job Description: The Clinical Team Manager works in close collaboration and is fully supportive of the Project Manager, assigned to a specific study team.
The role can be assigned to anyone who has the experience, skills, and competences to execute the tasks and responsibilities as listed below.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 revising 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.If you succeed we can offer you the opportunity to grow into enhanced roles within the department and also have examples of Clinical Team Managers who have moved into project management or management of CRAs.Qualifications: - Minimum Bachelor's degree in a Life Science discipline and/or at least 2 years' experience in clinical trials or related experience in the pharmaceutical industry or in a clinical setting.- Excellent planning, organizational, leading and managing multiple priorities, and time management skills