Senior Clinical Project Manager

Job not on LinkedIn

🔥 18 hours ago

🏄 California – Remote

🏄 California – Remote

💵 $150k - $170k / year

⏰ Full Time

🟠 Senior

🏥 Clinical Operations

👻 Ghost score 0%

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Balt

WebsiteLinkedInAll Job Openings

501 - 1000 employees

🏭 Manufacturing

🏥 Healthcare

💰 Private Equity Round on 2015-09

Manufacturing • Healthcare

Balt is a leading company in the medical equipment manufacturing sector, specializing in innovative solutions for interventionnal neuroradiology. With over 45 years of experience, Balt collaborates closely with physicians to develop advanced neurovascular and peripheral vascular medical devices. The company has made significant contributions to the field, including the introduction of the first neurovascular intervention device in 1977 and now offers a comprehensive portfolio for treating both ischemic and hemorrhagic strokes, as well as peripheral embolization.

📋 Description

• Provide project strategy, management, and proactive planning for one or more highly complex clinical projects • Ensure the safety and effectiveness of BALT and affiliate products • Oversee contractors, vendors, and project team members to complete deliverables on time and within budget • Manage and coordinate one or more clinical trials • Keep trials audit ready, including training records, central files, and system validation • Lead clinical study audits and mock audits involving regulatory authorities • Ensure project deliverables and milestones are achieved across multiple projects • Communicate with the Clinical Project Team, functional management, and BALT leadership • Develop and manage projects within approved budgets and timelines • Support selection, contracting, coordination, and management of CROs, vendors, and contractors • Develop study manuals, study tools, and operational plans • Compile proposed investigational site lists and participate in site review and approval • Travel to investigational sites to build clinical relationships and improve collaboration • Forecast required devices in collaboration with supply chain • Coordinate and attend investigator and coordinator meetings • Prepare and present clinical project status to Clinical Management • Manage corrective action plans at individual sites and across trials • Participate in internal and external trial-related audits • Mentor and train team members and provide best practices • Participate in non-trial-related process and procedure teams

🎯 Requirements

• Bachelor’s-level degree required • Degree in science/health-related field preferred, such as Biology, Nursing, Biomedical, Pharmacy, or Veterinary Sciences • 8+ years’ experience in clinical/scientific research, nursing, or medical devices/pharmaceutical clinical trials • Ability to independently manage multiple global complex clinical projects • Ability to analyze diverse information and collect research data • Ability to generate creative solutions and demonstrate attention to detail • Skill in gathering and analyzing information and developing alternative solutions • Ability to adapt to changes, manage competing demands, and handle unexpected events • Independently motivated, persistent, and able to overcome obstacles • Oral and written communication skills, including presenting data effectively and addressing senior leadership • Ability to develop interpersonal relationships with medical professionals • Thorough knowledge of clinical research conduct, laws, regulations, standards, and applicable BALT SOPs and policies • Light lifting, moderate computer usage, and extended periods of sitting or standing • Approximately 20% domestic/international travel

🏖️ Benefits

• Meaningful work improving patient lives • Close-knit, mission-driven team • Recognition of work and respect • Multicultural community • Travel opportunities to investigational sites, conferences, and domestic/international locations

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