Overview
Velocity Clinical Research is an owned and integrated research site organization, providing excellence in patient care, high quality data and fully integrated research sites. At Velocity, we align our values and behaviors to give our employees the best chance of delivering on our brand promise: to bring innovative medical treatments to patients. We are committed to making clinical trials succeed by generating high quality data from as many patients as possible, as quickly as possible while providing exemplary patient care at every step.
As an employee of Velocity, you are the most integral part of our mission. For talented candidates who perform at a high level, Velocity will invest to support career advancement and reward performance. Whether you are new to clinical research or are an industry veteran, we invite you to apply to Velocity.
Benefits include medical, dental and vision insurance, paid time off and company holidays, 401(k) retirement plan with company-match, and an annual incentive program.
Job Summary:
The Clinical Operations Project Manager will be responsible for the planning, execution, and oversight of clinical trials and projects to ensure they are completed on time, within budget, and in compliance with regulatory requirements.
Responsibilities
Duties/Responsibilities:
- Develop and maintain project plans, timelines, and budgets for assigned clinical trials and projects.
- Coordinate with cross-functional teams including Clinical Research, Regulatory Affairs, Data Management, and Quality Assurance to ensure alignment on project goals and objectives.
- Identify potential risks and issues and develop mitigation strategies to ensure successful project execution.
- Select, negotiate contracts with, and oversee third-party vendors and service providers involved in clinical trial activities, such as Contract Research Organizations (CROs), central laboratories, and clinical sites.
- Monitor vendor performance and adherence to contractual agreements, and address any issues or concerns in a timely manner.
- Ensure compliance with relevant regulatory requirements, including Good Clinical Practice (GCP) guidelines, and local regulations.
- Collaborate with Regulatory Affairs to prepare and submit regulatory documents and filings as necessary.
- Coordinate and allocate internal and external resources effectively to support clinical trial activities.
- Manage study budgets, track expenses, and provide regular financial updates to stakeholders.
- Serve as the primary point of contact for internal and external stakeholders regarding project status, progress, and issues.
- Prepare and present project updates, reports, and presentations to senior management and project teams as needed.
Required Skills/Abilities:
- Strong understanding of clinical trial conduct, regulations, and guidelines.
- Excellent organizational, problem-solving, and decision-making skills.
- Proven ability to manage multiple projects simultaneously and prioritize tasks effectively.
- Strong interpersonal and communication skills, with the ability to work collaboratively in a cross-functional team environment.
- Proficiency in project management software/tools and Microsoft Office suite.
- PMP or other relevant certifications are a plus.
Qualifications
Education and Experience:
- Bachelor's degree in life sciences, pharmacy, nursing, or related field; advanced degree preferred.
- Minimum of 5 years of experience in clinical operations/project management in the pharmaceutical, biotechnology, or medical device industry.
NOTE: The above Job Description is intended to communicate the general function of the mentioned position and by no means should be considered an exhaustive or complete outline of the specific tasks and functions that will be required. Additionally, specific tasks and duties of the position are subject to change as the Company, the department and circumstances change. All employees are expected to perform their duties within their ability as required by the job and/or as requested by management.