Clinical Project Manager
Fairfax
Engineering – Engineering /
FTE /
Remote
Vibrent Health is an innovative B2B2C SaaS-based mobile health technology company offering enterprise solutions. Our products enable research and clinical professionals throughout the U.S. in designing and managing large research projects and clinical trials for significant numbers of participants contributing through web and mobile applications.
We are seeking a Clinical Project Manager to join our Project Management Office (PMO) Team responsible for project management, cross-team coordination, and delivery of new clinical trials projects.
As our Clinical Project Manager, you will play a crucial role in managing and overseeing clinical trials projects that are outsourced by pharmaceutical, biotechnology, and medical device companies.
You will manage all phases of these initiatives including ensuring that detailed requirements are documented, and all functional and delivery teams are staffed and on schedule for delivery. You will develop an overall initiative project milestones and deliverables plan, and it will be your responsibility to manage issues and risks while maintaining an integrated project schedule and roadmap using our Atlassian Jira and Confluence tools.
To be successful in this role, you will need to effectively collaborate with stakeholders at the pharmaceutical, biotechnology, and medical device companies who have chosen Vibrent as the platform for their research.
Ultimately you will be accountable to guarantee that clinical trials are conducted efficiently, effectively, and in compliance with all regulatory standards. Your efforts will contribute to the successful development of new drugs, therapies, and medical devices and successful delivery of clinical trials or clinical research.
Vibrent Health is a remote-first organization, and this is a remote position. You will be equipped to work remotely on a team that is fully remote. Candidates in the Fairfax, VA area may utilize office space there and attend meetings face to face. Nationwide candidates must be prepared to attend daily meetings based on EST.
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Responsibilities
- Planning and executing clinical trials, defining project scope, objectives, timelines, and budget.
- Creating detailed project plans aligned with sponsor goals and regulatory requirements.
- Leading cross-functional teams, ensuring cohesion and alignment with project goals.
- Acting as main point of contact for sponsors, investigators, and stakeholders, providing updates and facilitating decision-making.
- Ensuring compliance with local and international regulatory guidelines (such as ICH GCP, FDA, EMA regulations,), overseeing document submissions.
- Identifying and mitigating risks to project timelines, quality, and budget.
- Resolving issues promptly to minimize impacts on trial success.
- Implementing quality assurance processes to ensure data integrity and compliance with study protocols.
- Selecting and managing vendors and clinical trial sites to meet study requirements.
- Managing and reporting on project status, progress, risks, and issues.
- Coordinating with customer project management, study, or research teams to develop comprehensive project plans and logs.
- Managing all project phases, gathering requirements, and documenting project scope in Atlassian Confluence and Jira.
- Maintaining systems to track project activities and deliverables allowing for effective communication of status to senior stakeholders and customers.
- Coordinating with functional teams to develop Epics and Stories in Jira projects.
- Developing and maintaining an overall Initiative Roadmap using Jira Advanced Roadmap.
- Managing Jira boards and creating or assigning tickets for various teams.
- Monitoring progress of Epics and deliverables, identifying dependencies and risks.
- Coordinating with technical teams on deployment and release schedules.
- Ensuring availability of customer demonstration and training environments.
- Maintaining project documentation consistently in Atlassian Confluence.
- Facilitating internal project status meetings and weekly Risks and Issues calls.
- Lead and facilitate weekly Risks and Issues call with functional team leads and/or senior stakeholders.
Required Qualifications:
- Minimum 5 years of hands-on project management or leadership experience in Study Design and Protocols, Clinic Trials, or Clinical Research that demonstrates a thorough understanding of project management principles, application of best practices to move the project forward, risk mitigation and issue resolution skills.
- Experience in project management planning and coordination best practices when collaborating with a customer’s project management team.
- Strong knowledge of FDA and International Conference of Harmonization and Good Clinical Practices (ICH/GCP) Guidelines
- Integrated Management Office or Project Management Office experience involving multiple cross-functional teams and processes.
- Demonstrated excellence in verbal and presentation communication skills to all levels of the organization and specifically during customer and stakeholder status calls.
- Organized with attention to detail specifically to all the moving parts of the project.
- Excellent analytical, logical thinking, and problem-solving skills and provide alternatives and solutions to risks, issues, and roadblocks to senior stakeholders.
- Thorough understanding of information technology procedures and practices, functional teams, development environments, as well as its dependencies and challenges.
Preferred Qualifications:
- Project Management Institute’s (PMI) PMP certification.
- Experience using Atlassian JIRA and Confluence Cloud as a project manager.
When you work at Vibrent, you are surrounded by a diverse group of people who share a passion for achieving excellence and making a lasting impact. Passion, excellence and impact should be rewarded, and we do that-- offering a competitive compensation package that includes over-average 401k match, the benefits you need to prioritize self and family care, and support for your further education and career development. One of the greatest benefits Vibrent offers is opportunity. At Vibrent, we work with the latest tools and technologies including enterprise mobile apps, fitness sensors, medical devices, cloud computing, machine learning, big data and analytics. We partner with national leaders in healthcare, technology, and research. We create tools that will change and improve healthcare for ourselves and future generations.
Vibrent is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, gender, national origin, age, sexual orientation, gender identity, disability, or veteran status.
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