Manager, Clinical Operations

The Company
Rion is a clinical-stage biotechnology company based in Rochester, Minnesota. Rion was founded as a Mayo Clinic Employee Entrepreneurial Program startup company. Rion’s mission is to develop clinically impactful and accessible therapies using innovative regenerative medicine technologies based on extracellular vesicle science. Our proprietary exosome platform has the ability to address significant unmet patient needs in many fields of medicine; accordingly, we are actively pursuing clinical programs in wound healing, cardiovascular diseases, and women’s health.  

Our ultimate mission is to deliver cutting edge solutions accessible to any patient in need, anywhere in the world. 

The Position
Reporting to the Senior Director, Clinical Development & Operations, the Manager, Clinical Operations manages one or more clinical studies from Protocol Concept to Clinical Study Reporting and Disclosure. This is an exciting opportunity for an individual with a proven track record of managing studies, including internal cross-functional collaboration and coordination, CRO and vendor management to join a dynamic team working to deliver high quality studies on time and within budget. The role is key to ensuring that study milestones and deliverables are achieved according to agreed quality standards and timelines and that quality of data are acceptable and suitable for regulatory submission. This individual ensures that assigned studies are executed according to ICH/GCP guidelines, applicable regulatory requirements, and standard operating procedures.  

Job Responsibilities: 

  • Managing study progress from start-up to close-out activities and end of study reporting. 
  • Assuring adherence to intended timelines to achieve study goals while ensuring compliance with international GCP guidelines/regulations and SOPs/SWPs, identifying risks and implementing risk mitigation plans. 
  • Coordinating interdisciplinary activities throughout the study. 
  • Oversight and management of CRO and clinical vendors as appropriate to ensure successful conduct of the clinical trial and to ensure data integrity and quality. 
  • Effective communication with KOLs and Investigator site staff to support study delivery. 
  • Contributing to individual and team development through training initiatives and team building activities
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  • Bachelor’s degree in biological science, nursing, pharmacy or equivalent as a minimum. 
  • Minimum 5 years of experience in the pharmaceutical industry in a position performing clinical operations functions.  
  • Proven track record as a clinical study manager including internal cross-functional coordination and CRO and vendor management to deliver high quality studies to time and budget. 
  • Previous pharma industry experience Managing early through late studies with preference to early phases. 
  • Demonstrated experience in the identification of emerging risks and the ability to collaboratively champion solutions within a multi-disciplinary drug development team to help resolve challenges. 
  • Must possess excellent project planning and priority setting skills, as well as excellent organizational and interpersonal skills and flexibility to accommodate to rapidly changing priorities and deadlines. 
  • Solid project and vendor management, analytical and problem-solving skills. 
  • Prior experience with forecasting, tracking and reconciliation of study budgets. 
  • Prior experience with authoring and coordinating the development of clinical protocols, Investigator brochures and study reports. 
  • Excellent written and verbal communication skills. 

Additional Information: 

  • Schedule: Monday – Friday 
  • Work Location: Remote  
  • Work Remotely: Yes 
  • Job Type: Full-time, Exempt 
  • Direct Reports: 0+ 

The Benefits 

Rion recognizes the importance of balance and flexibility in our work environment. We offer a wide variety of competitive benefits, services and programs that provide our employees with the resources to pursue career path their goals, both at work and in their personal lives. 

We provide a competitive compensation package with a unique culture focusing on development and wellbeing of our staff. Below are some of the benefits offered by Rion: 

  • Full Health, Dental and Vision Insurance for employees and their dependents. 
  • Choice between PPO or High Deductible Health Plan with Health Savings Account (HSA) 
  • Flexible Spending Accounts (FSA) 
  • 401K or IRA Retirement Savings Plan 
  • Life Insurance Programs 
  • Basic life and supplemental life insurance options for self, spouse, children 
  • Short and Long-Term Disability Insurance 
  • Paid Time-off, Paid Holidays, and Parental Leave programs 
  • Parking Benefits 

EEO Statement
Rion is proud to be an equal opportunity employer that complies with all applicable federal, state and local fair employment practices laws. Rion strictly prohibits and does not tolerate discrimination against employees, applicants or any other covered persons because of race, color, religion, creed, national origin or ancestry, ethnicity, sex (including pregnancy), gender (including gender nonconformity and status as a transgender or transsexual individual), age, physical or mental disability, citizenship, past, current or prospective service in the uniformed services, genetic information, marital status, AIDS/HIV status, smoker/nonsmoker, and occupational pneumoconiosis or any other characteristic protected under applicable federal, state or local law. 

Recruitment & Staffing Agencies
Rion does not accept agency resumes unless contacted directly by internal Rion Talent Acquisition. Please do not forward resumes to Rion employees, or any other company locations; Rion is not responsible for any fees related to unsolicited resumes. 

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