Senior Project Manager, Clinical Research

2 months ago
Job ID
2017-1802
US-GA-Kennesaw
# of Openings
1
Category
Clinical Research

Introduction

Is This The Role For You?

 

We hire smart people with big hearts.  People who have a passion for their work and who strive every day to help others. Our work requires bold and innovative leaders; people who bring strong values and ethics to their role.

 

If you’re ready for a career that allows you to grow and develop into the professional you want to be – today and in the future….CryoLife is the place for you.

Position Overview

Manage assigned departmental project tasks/systems in principal areas of responsibilities identified below.

 

Responsibilities

 

  • Develop clinical protocols and/or investigational plans, informed consent forms, case report forms, handouts, SOPs, analyses, etc. as needed. Prepare status reports, as required.

 

  • Liaison between CryoLife, investigational sites, and CROs (as applicable) to coordinate and document clinical research studies. Respond to written and telephone inquires from investigational sites, as applicable.

 

  • Collect, query, analyze, and present clinical data. Develop and maintain any applicable clinical research databases as necessary.

 

  • Identify required biocompatibility testing, work with legal to develop a contract and ensure timely completion and accuracy of final report.

 

  • Conduct basic statistical analyses for technical support of product line.

 

  • Conduct literature reviews and write research summaries related to product line.

 

  • Interface with technical representatives, regional managers, and research teams for the purpose of technical training and addressing customer questions/concerns.

 

  • Prepare product Instructions for Use and assist with labeling and labeling changes (including receipt of applicable translations).

 

  • Generate final clinical study reports.

 

  • Communicate with customers and field staff regarding the planning of clinical trials, complaints, problems, and general correspondence.

 

  • Evaluate and report on adverse events, complaints, and failures associated with the product line.

 

  • Attend surgical congresses as necessary.

 

  • Complete necessary product Clinical Evaluation Reports and/or any other reports necessary to support regulatory submissions.

 

  • Coordinate the execution of peer-reviewed projects (publications, posters, abstracts) marketing literature.

 

  • Responsible for site recruitment/selection, investigator meetings, and management of clinical study sites.

 

  • Ensure that clinical trials are conducted in accordance with applicable standards and regulations.

 

  • Oversee project budgets, budget change forms, accruals, and monthly reports.

 

  • Other assigned responsibilities (including previously identified tasks being performed at a higher level than one’s current title)

 

Qualifications

 

  • Minimum 4-6 years’ experience, within the medical/biomedical industry.

 

  • Experience managing a clinical project team and Phase III clinical studies.

 

  • BS in biological science, epidemiology, engineering, statistics, or other science-related field.

 

  • CRA certification or certification eligible.

 

  • Demonstrated statistical and computer skills (spreadsheet, relational databases, intermediate to advanced statistical analysis).

 

  • Willingness to travel up to 50% of the time.

 

Company Info

Who We Are.

 

CryoLife is one of the world’s contemporary medical device companies providing preserved human cardiac and vascular tissues, surgical adhesives and sealants, cardiac lasers and implantable end-stage renal disease access grafts for the repair of complex cardiac and vascular reconstruction surgeries. Since the Company’s inception in 1984, it is estimated that its products and tissues have been implanted in about 900,000 patients worldwide.

 

CryoLife technology and products bring restoration and hope to people all around the world. CryoLife headquarters are located in Kennesaw, Georgia, a suburb of Atlanta.

 

CryoLife is an Equal Opportunity/Affirmative Action employer.

CryoLife is committed to the philosophy of equal opportunity employment. We do not discriminate against any employee or applicant.  All qualified candidates will receive consideration for employment without regard to race, ethnicity, age, religion, sex, sexual orientation, national origin, citizenship, disability, veterans or other legally protected status.

 

Reasonable Accommodations
CryoLife is committed to providing reasonable accommodations both in the application and interview process, consistent with legal requirements. If you need a reasonable accommodation while seeking employment, please email ADA_Accommodation@CryoLife.com or call 770-429-5215. A Human Resources representative will return your call. Messages or emails for any reason other than accommodation requests will not be returned.

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