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Clinical Project Manager
4 months ago
**Clinical Project Manager**
Our client is an innovative, clin-tech startup providing expanded access clinical trials. The company is seeking an experienced Clinical Project Manager to join their growing team. In this critical role, you will be responsible for overseeing the successful execution of the expanded access programs, ensuring seamless coordination across all clinical operations functions.
**Responsibilities**:
- Develop and maintain comprehensive project plans, timelines, and budgets for the company's expanded access clinical trials
- Collaborate closely with the clinical operations, medical, data management, and regulatory teams to drive project milestones and deliverables
- Facilitate cross-functional meetings and communications to identify and resolve clinical operations-related issues proactively
- Monitor project progress, identify risks and mitigation strategies, and provide regular status updates to stakeholders
- Implement robust project management processes and tools to enhance visibility, transparency, and data-driven decision making in the clinical operations function
- Serve as the primary point of contact for external clinical partners, including investigative sites, CROs, and sponsors, ensuring a positive experience
- Contribute to the continuous improvement of the company's clinical project management practices, identifying opportunities to enhance efficiency and quality
Qualifications:
- 5+ years of experience as a Clinical Project Manager in the pharmaceutical, biotechnology, or contract research organization (CRO) industry, with a proven track record of successfully managing expanded access or other non-traditional clinical trials
- Exceptional project management skills, including the ability to develop and execute detailed clinical trial project plans, track progress, and mitigate risks
- Strong understanding of GCP guidelines and other relevant regulatory requirements governing clinical research
- Excellent communication and interpersonal skills, with the ability to effectively collaborate with cross-functional teams and external stakeholders
- Proficient in the use of project management software and tools, such as Asana, Trello, or Microsoft Project
- Adaptable and resilient, with the ability to thrive in a fast-paced, startup environment
- Bachelor's degree in a life sciences or healthcare-related field; PMP or CCRA certification preferred
**A strong-willed and resilient mindset is essential, as the successful individual will play a pivotal role in shaping the company's operational infrastructure and scaling the business. If you are energized by the challenge of building something transformative from the ground up, this is an unparalleled opportunity to make a lasting impact in the clinical research industry.**
Pay: $82,897.00 - $100,000.00 per year
**Benefits**:
- 401(k)
- Dental insurance
- Health insurance
- Paid time off
Experience level:
- 3 years
Medical specialties:
- Infectious Disease
- Nephrology
- Neurology
- Oncology
Schedule:
- Monday to Friday
Application Question(s):
- Do you have any experience/ exposure to expanded access programs?
**Experience**:
- Clinical Project Management: 3 years (required)
Ability to Relocate:
- San Jose, CA: Relocate before starting work (required)
Work Location: In person
