Job Description A 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 Additional information Why Should You Apply?
You won't 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.
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 wok 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