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M868656ttzkzsydykhq

Clinical Site Manager

System One Wayne, OH Full-Time
$69,669.00 (Careerbuilder est.) What is the Careerbuilder Estimated Salary? Only about 20% of the jobs in our search results contain salary information. When a job posting doesn’t include a salary, we estimate it by looking at similar jobs in the same industry in that location. It is not necessarily endorsed by the employer and actual compensation may vary based on your experience.
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ob Title: Clinical Specialist
Location: 100% Remote, up to 80% travel
Start Date: Immediate
 

Responsibilities:

  • Responsible for coordinating field activities with clinical site needs to ensure enrollment and study execution.
  • Able to work effectively with doctors and site staff to help drive study enrollment.
  • Assists with the overall successful conduct of assigned clinical sites consistent with applicable regulations, guidelines, and policies.
  • Conducts Site Qualification visits and assists with site start-up activities as needed.
  • Conducts Site Initiation visits and ensures ongoing training and education of coordinators, physicians, site staff (including Vascular Technologists), and others, as necessary.
  • Attends and supports clinical cases in a Cath Lab setting.
  • May assist in preparation of sections of the Investigational plan, study materials, and/or on-site training as needed.
  • Attends Industry meetings and/or conferences as needed.
  • Assists in follow-up and resolution of site issues as needed.
  • Assists in device allocation, reconciliation, accountability, and retrieval.
  • Assists with reporting, compliance, review, and resolution of device-related events/complaints.
  • Responsible for site follow-up regarding imaging feedback from Core Labs.
  • Able to refer to Standard Operating Procedures (SOPs) for guidance on everyday study tasks.
  • Participates in continuous training to enhance knowledge base.
  • Strong verbal and written communication, technical, and problem-solving skills.
  • Able to read, analyze, and interpret general business documents, technical procedures, and standard operating procedures.
  • Able to work effectively both independently and on cross-functional teams.
  • Interacts with in-house clinical, quality, regulatory, research and development, and data management teams as needed to ensure communication about site dynamics, enrollment, and study needs.
  • Works collaboratively with the Clinical Affairs team to ensure timelines are met.
  • Able to write reports, business correspondence, and procedure manuals effectively.
  • Able to frequently use general knowledge of industry regulations, practices, techniques, and standards.
  • Develops solutions to a variety of problems of moderate scope and complexity

Education and Experience:

  • Requires a degree in nursing, medicine, biology, or biomedical engineering with a clinical focus
  • Must have a minimum of 5 years of industry experience with medical device technology and a clinical trial research background
  • Possesses extensive Cath Lab and Intravascular Ultrasound (IVUS) Experience
  • Has strong knowledge of the Venous System
  • Strong project management capabilities
  • Knowledgeable of ICH and GCP guidelines
  • Strong computer literacy and familiarity with Microsoft products
  • Familiarity with Electronic Data Capture (EDC) systems

Additional Skills

  • Able to function effectively independently and on cross-functional teams
  • Strong critical thinking abilities
  • Flexible and able to work with deadlines
  • Solution-oriented and problem-solving attitude
  • Good project management and organizational skills. Ability to prioritize work.
  • Excellent verbal and written skills, good organizational, interpersonal, and team skills.
  • Hands-on team player with the ability to work in a fast paced, dynamic start-up environment.
  • Experience working with small cross-function product/process development teams
 

Recommended skills

Coordinating
Complex Problem Solving
Critical Thinking
Computer Literacy
Electronic Data Capture
Data Management

Location

CareerBuilder Estimated Salary What is the Careerbuilder Estimated Salary? Only about 20% of the jobs in our search results contain salary information. When a job posting doesn’t include a salary, we estimate it by looking at similar jobs in the same industry in that location. It is not necessarily endorsed by the employer and actual compensation may vary based on your experience.

x

What is the Careerbuilder Estimated Salary?

Only about 20% of the jobs in our search results contain salary information. When a job posting doesn’t include a salary, we estimate it by looking at similar jobs in the same industry in that location. It is not necessarily endorsed by the employer and actual compensation may vary based on your experience.
This estimation is based on Job title, Industry, Location and Skills
$69,669
Avg. Yearly Salary
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Job ID: BHJOB18630_147587

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