Clinical Team Manager
hace 7 días
Company Description
Ergomed and PSR joined forces together to create a leading orphan drug development expert team that will allow our clients to implement patient-driven solutions in their clinical trials. People living with a rare disease are at the center of everything we do at PSR. 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.
- 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,
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.
- You need to have exceptional interpersonal and problem-solving skills, with the ability to lead and train CRAs in different countries.
- Review site visit reports.
- Organize and chair CRA-calls.
- Prepare various study documents (ICF, worksheets, study manuals, etc.) to be reviewed by the Project Manager.
- Act as back-up for the Clinical Project Manager.
The actual allocation of tasks and responsibilities will be determined and captured at the beginning of the project in consultation with the study team.
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