Clinical Affairs Specialist PC 1610

Miltenyi Biomedicine•Gaithersburg, MD

10d•$109,417 - $128,702

About The Position

This position is primarily responsible for managing projects and programs that support the development of Phase I cell therapies with our academic partners. This role will also be responsible for supporting the implementation of projects to PMO global standards, Miltenyi business processes, strategic initiatives, and best practices to meet project goals. Support the leadership team in the development of project alignment, with the portfolio, to business strategy, functional constraints, and resource proficiency. The role applies professional expertise and company policies to resolve issues, determine appropriate actions, and refine processes as needed.

Requirements

B.S. in a science-related discipline, e.g. biology, chemistry, biotechnology, biochemistry, molecular biology, or a similar discipline; 5+ years’ experience in a similar role. Cell therapy experience preferred.
Exposure to project management techniques.
Must be familiar with a wide range of clinical research and project management areas, including maintenance of complex schedules, document management, internal/external communications, and regulatory frameworks.
Strong written and verbal communication skills.
Ability to problem-solve and think critically.
Understanding of the pharmaceutical and biotechnology industry.

Nice To Haves

Cell therapy experience preferred.

Responsibilities

Aid in the execution of the Phase I clinical trials from protocol design to the final clinical study report.
Execute high quality, integrated cross-functional plans for the project/clinical trial.
Coordinate the activities of functional groups that comprise the clinical department team for the product including, but not limited to clinical monitoring, data management, statistics, medical writing, medical monitoring, and safety to insure proper conduct and timely completion of all projects.
Apply best practices in the development, initiation, planning, execution, control and closing of projects. Manage resource shipments to clinical trial sites
Cross-functional planning throughout Miltenyi teams to ensure site readiness, including data review and working with local teams to arrange training.
Troubleshoot technical difficulties at the clinical trial sites and leverage other expertise within the Miltenyi team
Manage quarterly meetings with and collect data from the clinical trial sites
Engage multiple Miltenyi groups, including additional R&D teams, Marketing, Regulatory, and Sales, to leverage the resources from the clinical trials to further grow the Miltenyi pipeline and support future sales efforts
Ensure project documents are complete, current, and stored appropriately.
Create a positive environment by working collaboratively
Work with the team or project managers, program manager, and PMO to develop and maintain project KPI’s and dashboards.