Reports To:  Vice President, Applied Epidemiology
Location: Remote Work (US Only)
Term Period: This is a term position with funding through June 2023, with the opportunity for extension if additional funding is secured. (Consultancy opportunity may be considered).

Why Sabin:

Our mission is to make vaccines more accessible, enable innovation and expand immunization across the globe. We seek a future free from vaccine-preventable diseases. We are an innovative, collaborative and engaged team that values accountability, teamwork, partnership and driving impact. We are vaccine champions improving lives through immunization. Sabin staff, management and Board of Trustees are committed to developing a diverse, equitable and inclusive team.

Position Summary:

Sabin is seeking a Manager/Senior Manager, Clinical Research to implement, oversee and conduct interventional clinical trials for global and multi-site vaccine research program. The incumbent will work closely with the Principal Investigator (PI) and co-PIs to adhere to a strict study timeline and budget, while ensuring Sabin is meeting the highest standards for quality and safety. Overall responsibilities include coordinating with a range of partners to ensure on-time deliverables, oversee the maintenance of the study electronic Trial Master File (eTMF), coordinating site monitoring activities, performing risk management, and assuring compliance with Standard Operating Procedures (SOPs). The successful candidate will have experience managing vaccine clinical trials according to International Committee on Harmonization Good Clinical Practices (ICH GCP) and comprehensive understanding of global vaccine regulatory environments. Sabin’s Applied Epidemiology team is growing its project portfolio and the Manager/Senior Manager of Clinical Research will be an integral part of developing a long-term clinical research strategy, securing new project opportunities, and contributing to new projects execution.


Responsibilities:

Ethical and Regulatory Compliance
• Monitor submissions to institutional and national ethical review committees and regulatory authorities; collaborate and support the sites for successful approvals
• Oversee maintenance of study eTMF in compliance with ICH GCP
• Ensure trial is conducted according to local and national regulatory standards, ICH GCP, and Sabin’s quality management systems
• Maintain trial records in clinicaltrials.gov, as applicable

Study Start-up
• Coordinate testing of electronic data capture systems and support modifying in REDCap as needed
• Support the CRO with development of materials for site trainings on protocol and study forms
• Support sites in developing and adhering to clinical recruitment plans
• Support the CRO with development of study standard operating procedures (SOPs) and coordinate project-specific site trainings

Study Coordination and Monitoring
• Implement the project in line with contract, budget and protocol (e.g., implementation of protocol and amendments; protocol deviation prevention, tracking and reporting; investigational product management; timely investigator payments)
• Schedule and coordinate plans for Sabin’s site monitoring visits
• Organize audit of CROs study monitoring (e.g., pre-study, initiation, monitoring, and closeout), review reports, and training to ensure adherence to ethical, regulatory, and protocol requirements
• Track study progress and maintain study status updates (e.g., IRB approvals, regulatory document collection, enrollment, SDV status, study drug inventory, clinical specimen tracking)
• Participate in data review activities
• Identify any risks to study quality or timeline/budget adherence and develop mitigation plans
• Oversee study close-out and related reporting
• Prepare and conduct reporting for the funding agency in accordance with the contractual obligations

Strategy and Partnership
• Provide strategic input and leadership in study execution
• Serve as the main point of contact for day-to-day clinical study activities
• Present scientific data by communicating accurate, succinct summaries of clinical study work at partner and funder meetings
• Plan and lead regular study team calls to provide status updates and accountability to deliverables
• Coordinate quarterly funder reporting
• Write grants to actively contribute to expanding team portfolio
• May author scientific abstracts and/or publications

Requirements:

• Bachelor’s degree in relevant science field
• 7+ years’ project management experience, preferably in clinical vaccine development
• Demonstrated experience managing clinical research 
• Comprehensive understanding of ICH GCP guidelines, especially sponsor responsibilities, regulatory documentation, and study monitoring
• Experience with regulatory compliance audits and inspections
• Comprehensive understanding and experience conducting statistical analysis
• Experience supporting strategic development and execution
• Demonstrated ability to identify risks and skilled at contingency planning
• Proficient in Microsoft Office applications and organizational tools
• Proven ability to manage in a complex team environment, build relationships, collaborate, and understand what motivates others
• Excellent verbal and written communicator with ability to tailor approach toward the perspective of others; produce compelling presentations and accurate reports
• Strong attention to detail, ability to manage complex tasks, highly organized, dependable, and able to prioritize competing demands to meet deadlines
• Demonstrated ability to operate with purpose, urgency and accuracy in a fast-paced and deadline-driven environment
• Must demonstrate interest in furthering Sabin’s mission, superior service orientation
• Availability to travel with notice

Attributes that Are Important to Sabin:

• Diversity, Equity and Inclusion
• Problem-Solving and Critical Thinking
• Decision-Making
• Communication and Professionalism
• Initiative and Ownership
• Productivity and Quality Control
• Professional Development/Personal Learning

Other:

• Subject to a criminal background investigation
• Request for three professional references
• Verification of education/degrees

How to Apply:

To be considered, please submit your cover letter and resume via e-mail to [email protected] Please be sure to reference “Manager/Senior Manager, Clinical Research” in the subject line. Applications without a cover letter will not be considered. Your cover letter should: (1) address the reasons for your interest in this position; (2) describe the knowledge, skills and abilities you would bring the Sabin Vaccine Institute. No phone calls, please. Only short-listed candidates will be contacted.
Salary commensurate with qualifications and experience. Sabin Vaccine Institute has a generous benefits package (see https://www.sabin.org/careers/employee-benefits).
Sabin is an Equal Opportunity Employer. All applicants will be considered for employment without attention to their race, color, religion, national origin, ancestry, age, disability or genetic information, sex (including gender identity, pregnancy or sexual orientation), marital status, veteran status, or any other characteristic protected by applicable federal, state or local laws.