Clinical Team Manager

Company: ERGOMED PLC
Location: Cary
Posted on: February 17, 2021

Job Description:

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.Job Description* 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,Qualifications* 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 supervisionAdditional InformationWhy 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.

Keywords: ERGOMED PLC, Cary , Clinical Team Manager, Executive , Cary, North Carolina