Beschreibung
On behalf of our client in the Life Science industry, Harvey Nash is looking for a Coordinator of Local Studies for a 1 year project in Switzerland.
The role is about acting as global/regional coordinator of local studies and central point of contact for Country's (CPOs) Medical associates, facilitating local medical associates in executing, completing and reporting local studies to ensure quality and compliance according to GCP and health authority regulations, monitoring and tracking compliance according to quality indicators.
You are responsible for:
assisting CPO-Chief Scientific Officers (CSOs)/Medical Directors/Advisors and local trial planners (TPAs)/Clinical Research Associates (CRAs) to ensure local studies are conducted according to policies and procedures applicable to local studies facilitating initial concept sheet submission process (via MACCS), assisting CPO, Regional CD&MA associates and Global Medical Affairs Teams as necessary, coordinating implementation of MACCS expansion to incorporate submission of protocols, amendments and final reports for Global review, providing MACCS training to local associates as required. upon receipt of Global Medical Affairs Study Team (MAST) approval decision for each local clinical study ensure that NCC is allocated, study is set-up in ClinAdmin and folders in CREDI are requested accordingly monitoring and track data entry and updates of internal systems (eg, ClinAdmin), liaising with CPO trial operations associates to assist in quality improvement initiatives. coordinating document transfer and importation into appropriate repositories (eg, CREDI), assisting CPOs with using translation services to ensure Global teams have access to critical study information as needed tracking overall clinical study progress within Region and provide updates on performance and quality metrics to management and users participating in quality improvement initiatives and support health authority inspections as necessary utilization of MACCS by local medical associates (number of study concepts, protocols, amendments, study reports and publications). ensuring adherence to quality check process compliance with performing quarterly study updates minimizing risk for significant health authority inspection findings driving quality and compliance in the conduct of local studies, facilitating processes to ensure timely completion of studies, contributing to improving systems, processes and reporting tools that support local studies, establishing relationships with CPO study operation associates and be point of contact for regional associates regarding compliance of local studies with policies and procedures. facilitating completion of local studies enabling quicker time to publication and sharing important data with key customers and decision makers, overseeing processes to ensure high quality and compliant studies; minimizing risk form deviating from health authority and GCP guidelines. Requirements
2 years college (associate degree) and or at least 2 years experience in clinical research, preferably with phase IV studies Must have experience in Clinical Research and Project Management. Demonstrated knowledge of clinical trials, especially phase IV and investigator initiatedstudies, including GCP and other regulations. Demonstrated experience in project coordination and quality improvementinitiatives. Strong computer skills; MS Excel, MS Word and possibly a reporting tool. Lotus Notesdatabase or comparable system, a plus. Must be able and willing to learn new systems readily. Great attention to and have good eye for detail. Strong customer orientation, excellent interpersonal and oral/written communication skills. Ability to work effectively both independently/remotely and with teams, demonstrates a pro-active working attitude. Fluent in English (oral and written), other languages an advantage Are you available immediately, have experience working within a Life Science company?
Please send your complete CV (Word documents preferred)
For further details feel free to call me. I am looking forward to receiving your application.
