Contributes to the operational execution of clinical studies and supports complex global trials as needed.
Provides operational input on development, management and maintenance of study deliverables (i.e. timelines, study plans, documents, etc.) through collaboration with internal and external stakeholders.
Drives process / system enhancements related to GTS responsibilities / deliverables and manage / comply with various quality or compliance systems
Manages country planning, protocol level attributes and milestones/drivers in CTMS.
Manages the development and/or collection of study level documentation, support GTM in ensuring eTMF accuracy and completion for all studies.
Manages the global setup of study level non-clinical supplies.
Understands study level tools and plans.
Provides support to the GTM along with the appropriate teams for response to country/regulatory and IRB/IEC.
Provides operational input and participates in operational processes in support of the startup maintenance and close out of studies.
Assist the GTM in driving study execution.
Learns, observes and performs core GTS tasks and escalates appropriately.
Facilitates vendor creation and payment processing in conjunction with the appropriate stakeholders.
Raises possible issues for potential escalation to the appropriate colleagues.
Follows instructions, determines level of understanding and seeks clarification when needed.
Seeks guidance to navigate undefined tasks, challenges, and study tools/resources.
Develops, updates, and submits Transfer of Obligations to Regulatory Authorities.
Manages global vendor site lists and resolve issues related to global site lists.
Manages study mail-groups/distributions and SharePoint/Study Directory updates.
Participates, sets up agendas, and captures meeting minutes in study team meetings for assigned protocols.
Identifies issues and risks, develops mitigations, and escalates appropriately.
Participates in filing activities and any associated audits as applicable.
Qualifications
Degree Requirements
BA/BS or Associate degrees in relevant discipline
Experience Requirements
Experience in the use of industry Clinical Trial Management Systems and Clinical Trial Master File Systems is a plus.
Experience in Clinical Research or related work experience.
Global experience is a plus.
Key Competency Requirements
Technical Competencies
Basic knowledge of clinical research budgets including processing and tracking of site and vendor payments is preferred.
Knowledge of ICH/GCP and regulatory guidelines/directives.
Basic understanding of project management desired.
