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Job Title:  Manager, Clinical Research

Req ID:  22468
Job Category:  Clinical Support, Operations & Education
Country/Region:  US
State:  OH
City:  Mentor
Zip:  44060
Description: 

At STERIS, we help our Customers create a healthier and safer world by providing innovative healthcare and life science product and service solutions around the globe.

Position Summary

The Manager, Clinical Research plans, directs, and manages the activities of STERIS Endoscopy’s Clinical Research department.  This includes development of clinical study protocols, site selection and qualification, preparing Informed Consent materials, contracting resources, training, site monitoring, budgeting, study document management and financial management of sites. The Manager, Clinical Research will also provide clinical and technical support to product development activities, support product launches, and conduct post-market surveillance and evaluation activities.

 

The Clinical Research Manager is responsible for multiple projects and must be comfortable working both independently and in a team environment. The individual must have the ability to provide strategic and technical guidance to ensure clinical trials are properly defined, planned and executed.

 

100% remote work will be considered for this role for candidates that live outside of Northeast Ohio.

What You Will Do

  1. Responsible for management of all aspects of clinical study planning and execution within pre-specified program and company objectives (resources, timelines, budgets, contracts relationship management, identification of project risks & contingency plans); Effectively manage the Clinical Research team:
    1. Attract, retain, manage, and coach the members of the Clinical Research team
    2. Provide ongoing educational and motivational support to the Clinical Research team
    3. Support and achieve all corporate goals and initiatives relative to this department
    4. Foster collaborative relationships with key functions
    5. Drive a positive, collaborative, and results-oriented culture within the team
  2. Execute clinical development program from protocol design collaboration to the final clinical study report for assigned studies;
  3. Create and maintain Clinical Standard Operating Procedures (SOPs), systems and processes across study trials;
  4. Ensure clinical trial compliance with all regulatory regulations and standards domestically and internationally;
  5. Engage Key Opinion Leaders in clinical dialog around study design, conduct and interpretation of clinical results;
  6. Manage study sites and tracking systems for enrollment of subjects, regulatory document flow, study timelines, financial information, SAE, performance metrics and data flow;
  7. Data Management: manage Clinical Research Form (CRF) and Data Clarification Form (DCF) review, quality and information flow; Facilitate open and comprehensive communication among staff in diverse functional groups and between the company and partners, contractors and Customers;
  8. Consult on publications and data analysis
  9. Ensure all activities comply with the department, company and regulatory standards and procedures.
  10. Manage the day to day relationship and output of third-party vendors/consultants.

What You Need to be Successful

  • Bachelor's Degree in Nursing or Science required
  • Minimum of 10 years of progressive experience managing clinical departments within the medical device industry or Clinical Research Organization required
  • Minimum of 5 years’ experience managing a team preferred
  • Advanced knowledge of application of all regulatory regulations and guidelines pertaining to clinical trials;
  • In depth knowledge and understanding of all phases of clinical trials
  • Ability to manage multiple projects simultaneously;
  • Analytical thinker with problem solving skills and ability to adapt to changing priorities;
  • Excellent verbal and written communication skills with strong customer-facing orientation.
  • Excellent interpersonal skills with strong organizational skills and attention to detail are a must.
  • The ability to travel up to 50% is required

Offering You in Return

The opportunity to join a company that will invest in you for the long-term. STERIS couldn’t be where it is today without our incredible people. That’s why we share in our success together by rewarding you for your hard work. Hiring people who are in it for the long run with STERIS is our ultimate goal. We do this by providing competitive salaries, healthcare benefits, tuition assistance, paid-time off, holidays, matching 401(k), annual merit, and incentive plans.  Join us and help write our next chapter.

 

 

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STERIS is a $3B, publicly traded (NYSE: STE) organization with approximately 12,000 associates worldwide and operates in more than 100 countries.

If you need assistance completing the application process, please call 1 (440) 392.7047. This contact information is for accommodation inquiries only and cannot be used to check application status.

STERIS is an Equal Opportunity Employer.  We are committed to equal employment opportunity and the use of affirmative action programs to ensure that persons are recruited, hired, trained, transferred and promoted in all job groups regardless of race, color, religion, age, disability, national origin, citizenship status, military or veteran status, sex (including pregnancy, childbirth and related medical conditions), sexual orientation, gender identity, genetic information, and any other category protected by federal, state or local law.  We are not only committed to this policy by our status as a federal government contractor, but also we are strongly bound by the principle of equal employment opportunity.

The full affirmative action program, absent the data metrics required by § 60-741.44(k), shall be available to all employees and applicants for employment for inspection upon request. The program may be obtained at your location’s HR Office during normal business hours.


Nearest Major Market: Cleveland
Nearest Secondary Market: Akron

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