Full-Time
Manager – Clinical Programs
Confirmed live in the last 24 hours
Develops healthcare technologies for vascular conditions
Compensation Overview
$126,180 - $187,106Annually
Senior
Remote in USA
- BA/BS/RN/BSN or equivalent is preferred with 8+ years of biotech clinical research experience
- Highly effective organizational and communication skills
- Previous Field monitoring experience highly desirable
- Previous FDA or other regulatory body trial design experience preferred
- Medical device, pharmaceutical, biotech, or other regulated industry experience desired
- Knowledge of CFR and GCP/ICH requirements is required
- Demonstrated leadership skills and the ability to solve problems proactively
- Proficiency with Excel, MS Project, Contract development and vendor oversight
- CRO management experience a plus
- Ability to plan, identify risks, anticipate issues and outcomes and respond strategically, tactically and operationally while balancing short-term and long-term objectives of the Company
- Responsible and accountable for global clinical studies as part of a therapeutic program, inclusive of strategy
- Develops strong and collaborative working relationships with Key Opinion Leaders
- Hire, train and mentor study managers to develop project plans inclusive of database planning, enrollment projection, site ramp up through database lock and trial completion
- Develops staffing plans for onboarding and continuing career growth
- Oversees the timelines of data snapshots for study reports, DSMB and CEC meetings and FDA submissions
- Responsible for overseeing MS Project timelines for each project and uses these timelines to track and manage a project's progress
- Reviews and approves Penumbra marketing materials
- Participates in cross functional strategy plans with internal (Regulatory Affairs, Marketing, Reimbursement, R&D) and external (Key Opinion Leaders, Study Investigators, etc.) stakeholders to draft global clinical strategies
- Reviews and/or writes protocols and assists in CRFs development
- Manages and oversees data review, participates in safety review
- Collaborates with Medical Affairs and Marketing for clinical podium publications and presentations as needed globally
- Proactively looks for process improvements opportunities in the department and implements them
- Leads team in vendor selection and ensures strong relationships with those vendors (e.g. Core Lab, EDC, and CROs)
- Participates in internal/external audit as the subject matter expert
- Adhere to the Company’s Quality Management System (QMS) as well as domestic and global quality system regulations, standards, and procedures
- Understand relevant security, privacy and compliance principles and adhere to the regulations, standards, and procedures that are applicable to the Company
- Ensure other members of the department follow the QMS, regulations, standards, and procedures
- Perform other work-related duties as assigned
Penumbra, Inc. excels in pioneering healthcare technologies specifically designed for neuro and peripheral vascular conditions. This involves a focus on stroke revascularization and embolization, with leading products like the REAL Immersive System and ACE Reperfusion Catheters that underline their commitment to top-tier, patient-focused innovations. Their dedication to leveraging cutting-edge technology in medical solutions makes it an outstanding workplace for professionals eager to impact critical care positively and advance in the fast-evolving healthcare sector.
Company Stage
IPO
Total Funding
$3.4M
Headquarters
Alameda, California
Founded
2004