2247-1 Sr Study Specialist
Summary:
The company is the world leader in delivering therapeutics that provide meaningful advances to patients who live with serious and life-threatening rare genetic diseases. We target diseases that lack effective therapies and affect relatively small numbers of patients, many of whom are children.
These conditions are often inherited, difficult to diagnose, progressively debilitating, and have few, if any, treatment options.
The company aims to improve life and health outcomes for people with rare diseases by advocating the use of innovative company therapeutics, advancing the standard of care, and providing personalized support and services globally.
The Global Study Operations function is tasked with providing strategic direction on the feasibility, design, and conduct of clinical studies and drives the delivery of high-quality data to support the registration and approval of clinical development assets.
The function achieves this through the development and operationalization of Clinical Development Plans, study planning and delivery, cross-functional leadership of Study Execution Teams, operational trial expertise, and vendor management and oversight.
Role Description:
The Sr. 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 or Program Lead (PL). This may include contributing to and/or supporting study related matters that impact study participant safety, data integrity, study timelines, quality, and budget. The Sr. 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). Within the role, the candidate is expected to demonstrate and have proficient knowledge and experience in the following competencies:
Core Competencies:
Agility and Proactivity
Leadership
Communication and Collaboration
Technical Competencies:
Study Management and Execution
Compliance and Quality
Drug Development and Study Design
Product and Therapeutic Area Knowledge
Responsibilities include but are not limited to:
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
Present at investigator meetings as assigned
Ensure accurate and timely study entry and updates to
Facilitate Screening Authorization Forms sign off and oversee tracking, where applicable
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) 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
Education & Experience:
BA/BS or higher in nursing, life or health sciences is preferred.
Industry or relevant experience in lieu of education is considered.
Experience in a biotechnology or pharmaceutical company, oversight of external vendors including SOW, budgets.
The hiring range for this position is $57 to $67.87 per hour. The base pay actually offered will take into account internal equity, and may also vary depending on candidate’s geographic region, job-related knowledge, skills, and experience amongst other factors.
Harvest Technical Services is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, gender, gender identity or expression, sexual orientation, national origin, genetics, pregnancy, disability, age, veteran status, or any other federal, state, or local protected class.