Objective / Purpose of Role
The Study Specialist (SS) significantly contributes to or leads tasks related to the oversight of site monitoring, 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 participant safety, data integrity, study timelines, quality, and budget. The SS will demonstrate a greater level of independence in executing assigned tasks and manage more challenging or complex vendors, sites, regions, including issue escalations from CROs and effective relationship management with Key Principal Investigator(s).
Key Activities / Key Responsibilities
* Develop study specific documentation, as delegated by the Study Manager
* Contribute to the oversight of country and site feasibility assessment and site selection
* Oversight of CRO for IRB/EC related submission/approval activities
* Oversight of essential documents for study life-cycle management
* Develop/Oversee site and investigator training materials
* Ensure accurate and timely study entry and updates to ClinicalTrials.gov
* Process documents for signature in DocuSign
* Oversight of Clinical Trial Insurance
* Attend Global Study Operations team, vendor, and/or Cross-Function Study Execution Meeting(s) 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
Scope of the position
* Internal – Medical, Regulatory, QA, Finance, Supply Chain
* External – CROs, Vendors, Clinical sites and consultants contracted to support the trials
Qualifications
* BA/BS or higher in nursing, life or health sciences is preferred
Experience
* Industry or relevant experience in lieu of education is considered
* Experience in a biotechnology or pharmaceutical company, oversight of external vendors including SOW, budgets, POs, and invoice management (e.g., CROs, central labs, imaging etc.)
Core Competencies
* Candidate must demonstrate a growth mindset and willingness to learn
* Strong Agile thinker who adapts well to situations of fast-changing environments, using initiative and taking a proactive approach
* Leadership – Takes ownership, drives tasks forwards, and fosters collaboration.
* Communication and Collaboration – Engages effectively with stakeholders, demonstrating strong teamwork and collaboration
* Problem solver who can work through complex issues with a solution-oriented mindset
* Demonstrates a willingness to achieve goals together and respect the view of others
* Compliance and Quality – Upholds regulatory and quality standards with integrity and an ethical mindset.
Technical Competencies
* Study Management and Execution
* Drug Development and Study Design
* Product and Therapeutic Area Knowledge
Disclaimer
The above statements are intended to describe the general nature and level of work being performed by employees assigned to this classification. They are not to be construed as an exhaustive list of all responsibilities, duties, and skills required of personnel so classified. All personnel may be required to perform duties outside of their normal responsibilities from time to time, as needed.