About The Position
The Site Manager (SM) is engaged in facilitating the conduct of clinical studies. Specific focus is put on patient related site support, with the aim to maximise the utilisation of staff designated to a given study (e.g. study site coordinator, study nurse, sub-investigator) through provision of site training and oversight for logistically / technically more demanding study procedures. The SM is working under the supervision of Senior SM or Director of Site Management (or LSM on project level).
Requirements
- Educated to degree standard (preferably in medical / public health field) or appropriate equivalent work experience
- Previous experience in conducting site management/site support activities
- Fluent in English and German
- Good communications skills
- Good organisational skills
Responsibilities
- Conducts patient related site support as per study specific site management plan
- Ensures the progress of the clinical study and that it is conducted, recorded, and reported in accordance with the protocol, Ergomed standard operating procedures (SOPs), ICH GCP, and the applicable regulatory requirement(s)
- Acts as primary contact with Study Site Coordinator (SSC)/Research Nurse (RN)
- Participating in SM trainings
- Ensures continuous training, consultation, support and supervision of SSCs
- Assists in development of patient recruitment and retention strategies, and tracking of recruitment activities at assigned investigational sites
- Oversees IMP and other clinical trial supplies inventory and facilitates logistics for the shipment of samples
- Notifies LSM / CRA / CTM / PM on any site issue that is detected in contact with the site
- Establishes and maintains relationships with SSCs/RNs, Investigators and Sub-Investigators to optimize performance on clinical studies
- Participates in internal team teleconferences and meetings related to general site management group activities, as required on project level
- Prepares Site Management Visit report after on-site/remote visit
- Ensures that SM visit reports, phone contact reports and any relevant correspondence is provided for filing in eTMF as per study specific Filing Plan
- Supports in management of patient travel expenses or other expenses, preparation of calculation sheets and assistance in site's invoicing.
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What This Job Offers
Job Type
Full-time
Career Level
Mid Level
