Acts as primary local company contact for assigned sites for specific trials
May participate in site feasibility and/or pre-trial site assessment visits
Responsible for executing activities within site initiation and start-up, preparation and conduct of site monitoring (including remote monitoring), site management (by study specific systems and other reports/dashboards) and site/study close-out according to SOPs, Work Instructions (WIs) and policies
Responsible for the implementation of analytical risk based monitoring model at the site level and to work with site to ensure timely resolution of issues found during monitoring visits
Ensures site staff are trained and the corresponding training records are complete and accurate at any time point during all trial phases
Responsible in close collaboration with LTM and central study team for the activities during site activation phase in order to speed up the process and activate the site in shortest possible timeframe
Contributes to site level recruitment strategy and contingency planning and implementation in partnership with other functional areas
Ensures that clinical drug supplies are appropriately used, handled and stored and returns are accurately inventoried and documented.
Maintains complete, accurate and timely data and essential documents in relevant systems utilized for trial management
Complies with relevant training requirements.

A minimum of a BA or BS degree in Life Sciences, Nursing or related scientific field (or equivalent experience)
A minimum of 2 years of clinical trial monitoring experience is preferred
Strong working knowledge of GCP, company SOPs, local laws and regulations, assigned protocols and associated protocol specific procedures including monitoring guidelines
Strong IT skills in appropriate software and company systems
Willingness to travel with occasional overnight stay away from home
Proficient in speaking and writing the country language and English
Good written and oral communication.

Associate Site Manager – SSU

Key skills