Beschreibung
Task:- Participates in site feasibility and/or pre-trial site assessment visits, providing recommendation from local area about site/investigator selection in collaboration with the trial team
- Acts as primary local company contact for assigned sites for specific trials.
- Attends/participates in investigator meetings as needed.
- Responsible for executing activities within site initiation and start-up, site monitoring, site management and site/study close-out according to internal SOPs/WIs/IFUs and policies.
- Ensures site staff are trained and the corresponding training records are complete and accurate at any time point during all trial phases
- Works closely with LTM to ensure CAPA is completed for QA site audits and for quality issues identified at the site during routine monitoring and other visit types.
Requirements (Must have):
A Site Manager is the person in Site Management that serves as primary contact point between the sponsor and the investigational site. A Site Manager is assigned to trial sites ensuring inspection readiness through compliance with the clinical research protocol, company's Standard Operating Procedures (SOP), codes of Good Clinical Practice (GCP), applicable regulations and guidelines from start-up through data-base lock. Responsibilities include site selection, pre trial assessment, subject recruitment and retention planning, site initiation, monitoring and close-out. Partner with the CTA/IDA, LTM and GTM to ensure overall site management while performing trial related activities for assigned protocols. Contribute to process improvement, training and mentoring of other Site Managers.
- CRF Experiences (Case Report Form)
- Experience in Pharma/Medical or Consumer Product branch
- Fluent English
- Fluent German
- GCP (Good clinical practice) Knowledge
- ICH (International Conference on Harmonisation) Knowledge
- Indication experiences: Cardiovascular
- Indication experiences: Neurology
- Indication experiences: Oncology
- Indication experiences: Psoriasis
- Mediadata rave experiences
- SAE (Serious adverse event) Experiences
Environment/Miscellaneous:
„-3 Tage Reisen pro Woche (eher 2, also 50%).
Beginn: 01.03.2016
Dauer: 31.12.2016
Branche: Chemie/Pharma