Clinical Operations Manager II

3 days ago

Aurora, Colorado, United States CPC Clinical Research Full time
Job Title: Clinical Operations Manager II

Job Summary:

CPC Clinical Research is seeking an experienced Clinical Operations Manager II to oversee clinical operations management activities, define and monitor project scope, timelines, and deliverables, and provide expert advice in the design, writing, and review of project-related essential documents.

Key Responsibilities:

  • Oversee clinical operations management activities, including trial-related activities, vendor payments, and data management.
  • Define and monitor project scope, timelines, and deliverables from project initiation to close-out.
  • Provide expert advice in the design, writing, and review of project-related essential documents, including protocols, project management plans, case report forms, statistical analysis plans, and study reports.
  • Develop and manage multidisciplinary project team members, organize project team meetings, and ensure the overall quality of project services and deliverables.
  • Provide necessary updates and reports to the sponsor as outlined by the contract.
  • Plan and oversee the execution of investigator meetings as contracted.
  • Work with the Business Development team on budgets, proposals, and change orders.
  • Ensure both CPC and sponsor are aware of and in agreement on any change in project scope that has a financial or resource impact.
  • Adhere to local, federal, and international regulations, guidelines, and CPC Policies, Standard Operating Procedures (SOPs), and Work Instructions (WIs).

Requirements:

  • Nursing or BA/BS in a scientific field (or equivalent knowledge/experience).
  • 4 years of experience in a clinical research setting, preferably with at least 2 years of project/operations management experience in clinical research.
  • Demonstrated ability to adequately manage all facets of a clinical trial with minimal direction.
  • Thorough knowledge of the Good Clinical Practice guidelines and applicable FDA and ICH regulations for conducting clinical drug trials.
  • Proficiency in Microsoft Office, particularly Outlook, Word, and Excel.
  • Excellent communication and organizational skills.
  • Great attention to detail.
  • Exemplary skills leading and managing multi-disciplinary teams in a clinical research setting.
  • Ability to adapt quickly to new situations, manage conflicts, and resolve problems effectively.
  • Willingness to travel 20-25%.

What We Offer:

  • Comprehensive benefits package (medical, dental, vision, life, STD, LTD, etc.).
  • Matching 401(k) plan (dollar for dollar up to 4% of your eligible compensation, fully vested immediately).
  • 11 paid holidays.
  • 15-25 vacation days based on years of service.
  • Paid sick time (2.67 hours accrued bi-weekly up to a maximum of 80 hours).
  • In-suite exercise and relaxation room.
  • Monthly fun events (e.g., team building activities, games, charitable events, potlucks, picnics).
  • Flexible and remote work schedules.

CPC is an Equal Opportunity Employer:

CPC provides equal employment opportunities (EEO) to all employees and applicants for employment without regard to race, sex, color, ancestry, sexual orientation, gender identity, gender expression, marital status, religion, creed, national origin, disability, military status, genetic information, age 40 and over, or any other status protected by applicable federal, state, or local law.

Accommodations:

Applicants with disabilities may be entitled to reasonable accommodation under the Americans with Disabilities Act (ADA) and certain state or local laws. If you need assistance, please email our Human Resources team at careers@cpcmed.org.

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