Clinical Program Manager

1. Clinical Program Manager

The Clinical Program Manager is responsible for oversight of the clinical study conduct and reporting.  This role will serve as an scientific and technical advisor on all aspects of the global clinical research program throughout the product lifecycle.  Partners with leadership to oversee the daily execution of clinical studies performed by employees, contractors, and/or CROs. Identifies and gathers business requirements from stakeholders to ensure an aligned understanding of business needs for the development and maintenance of project plans/deliverables and budgets.  Serves as the key liaison between trial teams and leadership.  Solves complex business challenges, represents the department on cross-functional teams and contributes to special initiative projects as needed.   

2. Duties & Responsibilities

•  Supports the development of the clinical research program throughout the lifecycle, including the development of the clinical research strategy, overall objectives, timelines, milestones, project plans/deliverables, and budget
• Leads or provides input/review on the development of clinical study documents and processes (i.e. study protocol, statistical analysis plan, case report form specifications, reporting) to ensure scientific integrity of the clinical research design and strategy are achieved  
• Serves as liaison between trial teams and leadership throughout project lifecycle.
• Serves as a business partner with functional leaders concerning projects and operational decisions
• Participates in and assists with the planning and creation of project and/or vendor-related meetings and materials.
• Reviews status of project and budgets; manages schedules and prepares status reports.
• Monitors projects from initiation through delivery and performs regular analysis to ensure complete and proactive reporting of program health to leadership.
• Drives cross-functional project and initiative alignment involving close collaboration with internal stakeholders (Clinical Affairs, Regulatory, Marketing, Research & Development, Finance).
• Supports the implementation of standardized tools, visualization dashboards, reports, and executive review documents to assist in decision making, measuring program performance and drive business results.
• Assist the trial teams trending of protocol deviations and other quality metrics.
• Tracks vendor contract timelines and initiates renewal process as needed.
• Monitors key performance indicators (KPIs) and performance metrics; engages teams in proactive mitigations; facilitates early escalation of issues

• Maintains confidentiality regarding company related matters.
• Other duties as assigned.

3. Education

• BS in Life Sciences, Engineering, or related field.
• Preferred advanced degree in Life Sciences or related field.

4. Qualifications

• 5+ years of clinical research experience, cardiovascular medical device clinical research, PMA experience preferred
• Demonstrated understanding of FDA regulations, ISO-13485, ISO-9001, and GMPs
• Experience in start-up company environment is preferred
• Class II and III medical device experience
• Demonstrated ability to solve complex clinical research challenges, including both technical/scientific challenges and operational challenges
• Demonstrated ability to function as both a collaborative project leader and a project team member
• Project management experience and fluency with related tools
• Demonstrated ability to build trusting collaborative relationships with third parties (ex. CRO, Core Labs)
• Demonstrated ability to effectively communicate, collaborate and influence across all levels of the company and all levels of a clinical research project.
• Clinical research budget experience.

• Demonstrated ability to be well-organized, a self-starter, and able to function with minimal supervision.

• Proficient knowledge of medical terminology including cardiovascular medical device and cardiovascular pathophysiology.
• Proficient knowledge and demonstrated ability using MS Office Suite
• Understanding of medical device regulations and quality systems

5. Travel Requirements

Domestic and international travel, as needed (~10%).

6. Location

This position allows for remote-based employment, or employment based in the Alleviant Medical office (Austin, Texas, USA).  If remote-based, the candidate must maintain a suitable work environment (i.e. home office).  Home office supplies and equipment will be allocated and/or reimbursed, following employment agreement and agreement with the hiring manager.