Clinical Team Manager - Mississauga, Canada - Ergomed
Description
Company Description
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.
Job Description:
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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 retraining, performing comonitoring, 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 mínimal 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.
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