Clinical Project Manager

Location: San Jose, CA

Circulation

ZOLL Medical is a growing, innovation-driven company on the forefront of delivering medical devices to save lives, and software solutions to improve efficiency. With customers in more than 140 countries, we continue to expand our reach, as well as our product offerings. Hospitals, emergency medical services (EMS), and others trust us to provide high-quality products and exceptional customer service. ZOLL products are used every day across the globe to save the lives of people who suffer sudden cardiac arrest. From Real CPR Help® technology—an industry first—to the world’s only wearable defibrillator, our capabilities and features set us apart. But none of this would be possible without the motivation and dedication of ZOLL employees, and we’re invested in their success.

We offer competitive salaries and a comprehensive benefits package. Join our team. It’s a great time to be a part of ZOLL!

Location: This position can be 100% remote!

General Summary: 
Manage clinical projects and studies by collaborating with Clinical Affairs management in the implementation of various team and company objectives for the execution of clinical studies.

Essential Functions

Project Management:
• Provide project support for both U.S. and International Clinical Trials consistent with applicable regulations, guidelines and policies.
• Ensure conformance with GCP, trial protocols and trial safety reporting requirements
• Lead projects that support division and company objectives
• Skillfully develop, nurture and maintain relationships with investigators, coordinators, site staff and all members of ZOLL with whom this individual works
• Adhere to study execution strategy in order to meet business objectives
• Implement immediate and long-range plans to carry out objectives for new and ongoing clinical trial research in support of regulatory submissions in a timely and efficient manner
• Simultaneously balance multiple business, clinical, product and physician requirements
• Contribute in both a leadership and individual contributor capacity, depending on the need and circumstance.

Study Related Tasks:
•Ensure timely completion of case report forms and queries at clinical centers within timelines determined by the company by tracking visits and reports
•Contribute to the development of study documents such as study manuals, worksheets, etc.
•Track budget approvals and site payments
•Responsible for Device shipment and Device accountability
•Interface with Data Management and EDC to generate reports and track data collection, query resolution
•Write and/or review adverse event narratives to support world-wide adverse event reporting requirements

Site/CRO/Investigator Management
•Manage site qualification, activation, monitoring and close-out activities and reports as necessary
•Ensure protocol adherence at all clinical centers in order to maintain a high level of compliance, data integrity and the highest possible percentage of patient follow-up
•Support IRB/EC/CA submissions and renewals 
•Oversee site contracts, payment schedules and payments
•Perform clinical monitoring activities as needed to ensure compliance with the investigational protocol, good clinical practices and appropriate regulations 
•Support activities performed by Contract Research Organizations (i.e. CROs, core labs)
•Support audits of CROs and other outside vendors as necessary

Training/Scientific Meetings/Other Duties as Assigned
•Manage site initiation training of investigators, coordinators and other hospital/clinical center staff in order to properly prepare sites throughout the clinical trial to assure correct implementation of study protocols, data collection and superior data quality and integrity
•Manage training of CRAs, Consultants, and Contract CRAs, as needed.
•Participate in the development, review and approval of departmental SOPs
•Attend relevant scientific/medical meetings as needed
•Responsible for other duties and projects as assigned

General Departmental Responsibilities:
•Confer with Clinical Affairs and other management staff regularly to review internal progress towards goals and objectives, as well as external conditions and required actions, mitigations, or changes needed.
•Comply with ZOLL Circulation’s quality system requirements as well as any applicable regulatory requirements
•Maintain up-to-date knowledge of global medical device regulations
•Interact with equivalent level intra- and inter-organizational management and staff concerning matters of significance to the company.

Education/Experience Requirements:

  • Must have relevant experience executing clinical programs in cardiovascular medical devices, particularly interventional cardiology or ICU-based clinical trials.
  • BS degree in life sciences plus 7 years of related work experience, or equivalent combination of education and experience 
  • Prior people management and clinical trial project management experience required

Supervisory Responsibilities:

May manage subordinates in the Clinical Affairs Department and is responsible for the coordination and implementation of the projects within the unit. When supervising others, carries out supervisory responsibilities in accordance with the organization's policies and applicable laws. Responsibilities include interviewing and training employees; planning, assigning, and directing work; appraising performance; addressing complaints and resolving problems.

Travel Requirements:

May be required to travel 30-40% of the time.

Skill Requirements:

  • Analytical – Analyzes complex or diverse information; collects and researches data; uses results, intuition and experience to synthesize product specific direction
  • Design - Generates creative solutions; demonstrates attention to detail
  • Problem Solving - Gathers and analyzes information skillfully; develops alternative solutions; works well in group problem solving situations
  • Oral Communication – Speaks clearly and persuasively in positive or negative situations; listens and gets clarification; responds clearly to questions
  • Written Communication – Writes clearly and informatively; presents numerical data effectively; able to read and interpret medical, scientific and engineering literature
  • Organizational Support - Supports organization's goals and values
  • Adaptability & Dependability – Adapts to changes in the work environment; manages competing demands; changes approach or method to best fit the situation; able to deal with frequent change, delays, or unexpected events.  Takes responsibility for own actions; keeps commitments; commits to long hours of work when necessary to reach goals
  • Innovation - Displays original thinking and creativity; meets challenges with resourcefulness; generates suggestions for improving work; develops innovative approaches and ideas
  • Motivation - Sets and achieves challenging goals; demonstrates persistence and overcomes obstacles; measures self against standard of excellence