Clinical Data and Project Manager

Galatea Bio•Miami, FL

15d

About The Position

Who We Are Galatea Bio is an innovative, venture backed biotechnology company with a mission to advance precision health for all. Founded by pioneers in the human genetics and bioinformatics industry, we identified a major gap in the way underrepresented communities are included in and derive benefit from advances in precision health, such as the development of new tests and cures. The last 20 years have seen an explosion of genetic information and data. New technological advances have made it faster and less expensive to understand the human genomes but most of those resources have focused on northern European communities. The mission of Galatea Bio is to channel the diversity of the world into advancing genomic medicine for the benefit of all. Leveraging clinical-grade biobanking, research and clinical genomics, and best-in-class ancestry and genome annotation algorithms, we will better understand the genetic architecture of underserved populations and power the next generation of precision medicine studies while maintaining an uncompromising commitment to ethical research. Read more at www.galatea.bio . About this opportunity As our Project Manager you will lead the launch of a new research project, from scratch, ensuring the achievement of milestones and deliverables in a timely manner. Parallel to launch you will also develop our internal knowledge base and establish the infrastructure for future research projects at Galatea Bio; from IRB approvals, to tooling, to documentation and tracking. You will be the liaison between study participants, research staff, and all stakeholders involved with ensuring a successful study. In this role you will report to the VP of Clinical Testing & Quality Control.

Requirements

At least 5 years of clinical research coordination experience and/or recruitment of individuals into research studies.
Strong planning and project management skills, with a natural ability to influence collaboration
Practical experience within a Contract Research Organization or as part of a multi-site Clinical Study.
Excellent organization and communication skills, with high attention to detail.
Proficient with clinical study software, such as REDCap, ClinCapture, Castor, viedoc, etc.
Bilingual in Spanish is required

Nice To Haves

CITI certifications and practical experience with IRBs are a major plus.

Responsibilities

As your first initiative, you will be responsible for monitoring sample and data flow for two new Miami-based studies and coordinating with our ex-US team for an ongoing study in Colombia.
As an integral component of your project plan, you will also scope out potential project risks, and preemptively incorporate efforts to minimize issues effectively.
Coordinate resources, timelines, and deliverables for both short term and long term objectives.
Collaborate with our recruitment team to perform intake assessments and data collection / management.
Maintain an overview, ensuring availability of inventory equipment and supplies at given research sites.
Enhance and take ownership of our repository of study files, including regulatory binders, source documentation, and other relevant material.
Conduct regular updates on project milestones and progressive performance of your studies, including patient onboarding rates, recontacting rates, and data deposition rates.