Global Studies Associate Ii
I am responsible for providing operational support to multiple cross-functional global Study Management Teams (SMTs) through all phases (phases1b- IV) and stages (start-up, conduct and close-down) in accordance with appropriate quality standards including ICH/GCP and applicable regulations.My main Responsibilities and Accountabilities include:Provide operational support to multiple global Study Management Teams (SMTs):• Develop and maintain effective working relationships… Show more I am responsible for providing operational support to multiple cross-functional global Study Management Teams (SMTs) through all phases (phases1b- IV) and stages (start-up, conduct and close-down) in accordance with appropriate quality standards including ICH/GCP and applicable regulations.My main Responsibilities and Accountabilities include:Provide operational support to multiple global Study Management Teams (SMTs):• Develop and maintain effective working relationships with members of the SMT involved in running clinical studies • Assist with effective communication and information sharing within the SMT and with external partnersResponsible for reviewing and maintaining accurate study level progress information through the efficient use of systems, tools and reports:• Contribute to the development, set up and maintenance of study specific tools• Review standard study related reports and liaise with accountable study members to address any inconsistencies• Identify any data or quality issues through the use of study related reports and ensure any discrepancies are escalated• Provide the SMT with guidance and know how to support the effective use of system functionality and reports to ensure consistency across SMTs.Coordinate activities with CRO vendors to meet study timelines:• Responsible for communication between the study team and vendor for defined tasks and tracking information • Trouble shoot issues ensuring vendor and CROs are meeting study timelines• Ensure essential study information is tracked• Responsible for managing the delivery of non-drug equipment to sites • Ensure site personnel access to vendor systems is granted Identify and contribute to areas of best practice and process improvements Show less