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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 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 supervision
