Manager, Investigator Initiated and Expanded Access Programs

California Jobs; San Mateo (CA); Remote; USD 80,000 - 110,000; Full time

Job summary

An innovative firm is seeking an experienced Manager for Investigator Initiated and Expanded Access Programs. This remote role involves managing all aspects of expanded access programs and IITs, ensuring compliance with FDA regulations and Good Clinical Practice guidelines. The ideal candidate will excel in project management, cross-functional collaboration, and vendor management while demonstrating strong communication skills. Join a forward-thinking organization that values your expertise and offers a dynamic work environment where your contributions can make a significant impact.

Qualifications

• 5+ years of experience in clinical research or pharmaceutical industry.
• Strong ability to manage multiple projects and prioritize effectively.

Responsibilities

• Support IIT and EAP operations and project management.
• Coordinate with Quality and Clinical Supply Chain colleagues as needed.

Skills

Project Management

Interpersonal Communication

Data Analysis

Multitasking

Education

BS Degree

Tools

Microsoft Office Suite

IIT Tracking Software

Veeva Systems

Job description

Manager, Investigator Initiated and Expanded Access Programs

We currently have an exciting opportunity available for an experienced Investigator-initiated (IIT), post-marketing clinical trials, and Expanded Access program Manager or Sr. Manager. The ideal candidate will be responsible for the effective management of all aspects of expanded access programs and IITs, including implementation in multi-institutional and research settings in accordance with FDA regulations and Good Clinical Practice guidelines. This role will also assist with program management, including the use of the BGNE contract system for creating and tracking contracts and report creation through the CG portal. This is a remote position, with no direct reports.

Essential Functions of the job:

1. Support IIT and EAP operations and project management, cross-functional collaborations, process improvement, and vendor management. This includes tracking and measurement of IIT KPIs.
2. Work with the EA Program to maintain ongoing programs and lead the implementation of new programs.
3. Support monthly study status reports and maintain updated study information in the CG portal.
4. Interface with the Accounting Department to manage POs, record, and reconcile all payment information and invoices for the studies managed.
5. Coordinate with Quality and Clinical Supply Chain colleagues as needed on IITs and EAPs managed.
6. Track study progress, including milestones and payments, for studies managed.
7. Demonstrate strong interpersonal skills for effective professional communication, aiming to cultivate strong working relationships with internal and external groups.
8. Effectively communicate complex medical/scientific information.
9. Provide operational assistance to field medical teams on trials and activities.
10. Position level will be commensurate with experience.

Education Required:

• BS Degree required.

Qualifications:

BS Degree required with 5+ years of overall experience and at least 1 year within the pharmaceutical industry, clinical research, consulting, or CRO.

Experience with Microsoft Office Suite, IIT tracking software, and Veeva systems.

Experience in creating data extracts and reports.

Ability to plan, prioritize, and execute multiple projects; capable of multitasking and working both independently and within multidisciplinary teams.

Travel:

• Work-related travel approximately 5-10%.

All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or protected veteran status.