Clinical Trials Operations Manager II

2 weeks ago

Raleigh, North Carolina, United States CPC Full time
Job Overview

CPC is seeking a talented Clinical Trials Operations Manager II to join our dynamic team.

If you excel in organization and thrive in adapting to changes while balancing strategic objectives with daily responsibilities, you may be the ideal candidate for this position.

This role is crucial as the primary liaison for industry-sponsored clinical trials and Endpoint and Specialty Services initiatives.

Key Responsibilities:

  • Oversee clinical operations management activities
  • Establish and monitor project scope, timelines, and deliverables throughout the project lifecycle
  • Assess training requirements for team members and ensure completion and documentation of necessary training
  • Supervise trial-related activities
  • Authorize and manage vendor payments
  • Provide expert guidance in the creation, evaluation, and revision of essential project documents including protocols, case report forms, and study reports
  • Lead and develop project teams
  • Guarantee high-quality project services and deliverables
  • Deliver regular updates and reports to stakeholders
  • Coordinate and facilitate investigator meetings as needed
  • Collaborate with the Business Development team on financial matters
  • Ensure alignment between CPC and stakeholders regarding project scope modifications
  • Assist in maintaining essential documentation as directed by the Head of Trial Master File
  • Adhere to all regulatory standards and guidelines for clinical trials
  • Define and oversee Endpoint and Specialty Services project scope, timelines, and deliverables
  • Manage deliverables for external committees
  • Supervise the SAE process and execution of safety plans
  • Oversee data entry processes and documentation
  • Provide constructive feedback to study sites regarding quality issues
  • Manage Endpoint and Specialty Services CPC Core Lab operations
  • Support biostatistics and programming efforts

Qualifications:

  • Bachelor's degree in Nursing or a scientific discipline
  • At least 4 years of experience in clinical research
  • A minimum of 2 years in project or operations management within clinical research
  • Strong knowledge of Good Clinical Practice guidelines and FDA/ICH regulations
  • Proficient in Microsoft Office applications
  • Exceptional communication and organizational abilities
  • Meticulous attention to detail
  • Demonstrated experience leading interdisciplinary teams in a research context
  • Capability to adapt swiftly, manage conflicts, and resolve issues effectively
  • Willingness to travel as required

*Background and education verification checks will be conducted for selected candidates.

Compensation Range: $72,000 – $90,000 annually

About CPC

CPC is a prominent academic research organization specializing in comprehensive clinical trial management, providing timely access to Key Opinion Leaders across diverse therapeutic areas. With over thirty years of experience, CPC has successfully overseen numerous clinical trials, focusing on critical areas such as cardiovascular health, wound healing, and diabetes management.

CPC manages trials funded by Industry, NIH, and Investigator Initiated sources. Additionally, CPC Community Health implements innovative programs aimed at fostering active and healthy lifestyles within communities.

Benefits at CPC include:

  • Comprehensive benefits package
  • 401(k) plan with immediate vesting
  • Generous paid holidays and vacation days
  • Paid sick leave
  • In-suite exercise and relaxation facilities
  • Regular team-building and social events
  • Opportunities for flexible and remote work arrangements

Explore our website to learn more about our mission and values. CPC is an Equal Opportunity Employer, ensuring fair opportunities for all applicants. Employment decisions are based solely on job-related factors.

Individuals with disabilities may qualify for reasonable accommodations under the ADA. For assistance, please reach out to our Human Resources team.

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