Site Manager (clinical research, local site coordinator role)

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 site 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).
Role and 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.
Educated to degree standard (preferably in medical / public health field) or appropriate equivalent work experience
Previous experience in conducting site management/site support activities
Language: Fluent in English and German
Good communications skills
Good organisational skills

Employment type
Full-time

Work arrangement
Yes