Manager, Clinical Research - US Remote

About Route 92 Medical

Route 92 Medical is on a mission to improve outcomes for patients undergoing neurovascular intervention. At the core is a reconsidered procedural approach, cutting-edge engineering, and innovative product design. Our portfolio targets the most significant challenges in neurointerventional care to deliver meaningful solutions. The company was founded by physicians developing thoughtful product solutions in collaboration with the world’s leading clinicians, who focus on improving procedural and patient outcomes. 

https://www.route92medical.com/

Chart a new course

Route 92 Medical is looking for dynamic, innovative people who are inspired by our mission to improve outcomes for patients undergoing neurovascular intervention.

We welcome team members who approach their work with courage, flexibility, persistence, and a willingness to assist others. Teamwork matters here. We are committed to collaboration and finding innovative solutions that advance neurovascular intervention, establishing Route 92 Medical as one of the premier companies in the field.

PURPOSE OF JOB: 

This position will support Route 92 Medical's efforts to manage clinical trials according to the Code of Federal Regulations, Good clinical Practice and the Declaration of Helsinki and the trial protocol. The individual taking this role will also manage relationships with investigators, site research staff, and ensure high-quality data quality through the monitoring of patient data in the database. This person will assist in the management of other team members in the Clinical Research Department and provide support to the Vice President in all assigned activities required by the role. This role will be 100% remote in the US. 

RESPONSIBILITIES: 

• Plan and oversee clinical trials.
• Provide regulatory oversight of clinical research trials through compliance monitoring, documentation management and ethical management.
• Assist in the management of Project Managers, Clinical Research Associates and Clinical Trial Associates
• Participate in performance management of Clinical Research Team members as assigned.
• Assist with conflict resolution.
• Independently develop process optimization techniques to facilitate trial enrollment while also maintaining a high level of integrity and data quality.
• Facilitate resource allocation.
• Collaborate with cross-functional teams to manage clinical trials at a high level.
• Investigate and resolve data correctness and quality issues.
• Support strategic quality initiatives and projects.
• Participate in risk management activities.
• Follow guidance on regulatory compliance and research ethics.
• Excellent communication and teamwork abilities.
• General knowledge of regulatory requirements and quality management systems.
• Other duties as assigned.
• Travel: Up to 20%.

SKILLS FOR SUCCESS: 

• Excellent written and verbal communication skills 
• Adaptable to a fast-paced environment – a flexible attitude is a plus in a fluid, dynamic growing company.
• Attention to detail and focus on the identification of potential issues and continuous improvement
• Experience with Electronic Data Capture Systems
• Collaborative team attitude to support the goals of the Clinical Research Department and Route 92 Medical.
• Knowledge of the laws and guidances that govern medical device clinical research such as the Code of Federal Regulations, Good Clinical Practice, Anti-Kickback Statute (AKS), the Declaration of Helsinki, etc.

REQUIRED EDUCATION: 

• High School Diploma or equivalent 
• Clinical research certifications a plus

REQUIRED EXPERIENCE: 

• Minimum of 10 years of clinical research work experience
• Familiarity with electronic data capture systems and neuro imaging portals 
• Proficient in Outlook, Word, Excel and PowerPoint 

BENEFITS & PERKS

• Comprehensive healthcare benefits are effective day one! R92M offers generous benefit options, including Medical, Dental, Vision, Life Insurance, FSA, HSA, Short-term and Long-term disability, Critical Illness Insurance, and Accident Insurance.
• Competitive base pay plus corporate bonus program
• Generous paid time off and 16 paid holidays, including a company-wide summer recharge week in July
• 12 weeks of paid parental leave for employees after 90 days of employment
• Monthly cell phone stipend

The actual base pay is dependent on several factors, including, but not limited to, work experience, market data, skills, geographic location, and business needs. The base pay range is subject to change and may be modified in the future. This role may also be eligible for equity.