participates in the planningand implementation clinical research projects; contributes technical and clinical operations expertise
May co-ordinate the activities of relevant colleagues within the Company and investigators to ensure compliance with the overall scientific study objectives. May work with international investigators and key customers as well.
Travels to field sites to monitor studies.
Under moderate guidance; plans and prepares studies.
Reviews study protocols, reports and manuscripts. Contribute technical and clinical operations expertise for these documents
Works with Data Management and Biostatistics staff on the design of documents and processes for the collection of study data from participating sites.
Collects and maintains legal and regulatory documentation, as applicable.
Manages training and coordinating certification of study site personnel.
Ensures accurate and complete study management/data collection and transfer to data management.
Ensures site compliance with regulations and study protocol.
Monitors the sites and provides technical assistance, as necessary.
Manages material logistics for the studies.
Conducts reference material testing in-house.
Organizes investigator meetings, as necessary.
May act as a lead for assigned projects and/or Project Team Meetings.
Evaluates and escalates decisions impacting project team and/or work area(s) and/or broader organization.
Maintains a high level of professional expertise through familiarity with scientific literature, Company product portfolio, and competitve environments.
Processes and applies specific knowledge to the completion of difficult work assignments.