Study Specialist II

Job ID: 24-01031

Hybrid role - will need ot be local to come onsite as needed.

Responsibilities include but are not limited to:

Develop and/or review study specific documentation, as delegated by the Study Manager

Contribute to the management of country and site feasibility assessment

Provide support in the management of Regulatory document collection and tracking (in the absence of a CRO) for participating sites

Contribute to the collection and oversight of essential documents for study life-cycle management

Contribute to the development of site and investigator training materials

May present at investigator meetings as assigned

Ensure timely study entry and updates to ClinicalTrials.gov

Ensure investigator payment: site set-up, pass-through processing, visit payment processing and funding processing (in collaboration with payment vendor)

Provide administrative assistance with internal and external meetings including investigator meeting(s) as warranted

Facilitate Screening Authorization Forms tracking/sign off where applicable

Manage various Global Study Operations document translations as applicable

Process documents for signature in DocuSign

Site management for delegated site(s)

Manage and resolve site related issues and risks escalated to *** that can't be resolved by CRO.

Contribute to identifying risks identification and mitigations

Oversee the Clinical Trial Insurance process

Support Study Manager to ensure timely delivery and handling of IP to the sites

Support Vendor Management

Attend internal Global Study Operations team meetings, vendor meetings, and/or Cross-Function Study Execution Meeting(s) as GSO representative and take meeting minutes as requested.

Oversee and manage essential documents in the Trial Master File (TMF)

Contribute to Global Study Operations risks identification and mitigations.

Provide support and administrative assistance with internal and external meetings

Assist with filing GSO internal study documents in internal systems

The Study Specialist II (SS-II) contributes to or leads tasks related to the oversight of site monitoring, site management and/or vendor management, and other activities as delegated by the Study Manager. This may include contributing to and/or supporting study related matters that impact study timelines, quality, and budget. Within the role the candidate is expected to show and have proficient knowledge and experience in the following competencies:

Core Competencies:

Agility and Proactivity

Communication and Collaboration

Technical competencies:

Study Management and Execution

Compliance and Quality

Drug Development and Study Design

Product and Therapeutic Area Knowledge