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.

Description:

• The Senior Study Specialist (SS) significantly contributes to or leads tasks related to overseeing 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 managing 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 the clinical trials government website.
• 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.

Skills:

• 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.)

Education:

• BA/BS or higher in nursing, life or health sciences is preferred.
• Industry or relevant experience in lieu of education is considered.

The hiring range for this position is $51 to $61 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.