Clinical Data Manager Whole Biome is on a mission to help people improve physical and mental health by creating a new category of products that target the microbiome. We are researching, developing and commercializing a novel class of rationally-designed Live SynbioticsTM (probiotics + prebiotics) that have demonstrated clinical efficacy to treat conditions like metabolic syndrome, inflammation and neurodegeneration. Whole Biome has created proprietary pipelines to build a unique discovery platform that identifies key, novel bacterial strains and the prebiotics that feed them. We are a highly collaborative team of scientists, engineers, physicians, marketers and salespeople interested in improving human health by using the latest research from diverse fields, such as, microbiology, molecular biology, high-throughput genomics, distributed computing, pharmaceutical development and nutrition. We believe strongly in an individual’s transparency and strong communication to enable the most effective and efficient path to team success. If you’re interested in building a new category of products that will help improve the lives of people globally and you love working in a cross-functional, collaborative, inspiring environment, please continue reading! Whole Biome is currently seeking an experienced Data Manager to join the Clinical Team. The person will provide hands–on support to internal and external clinical study staff. The clinical data manager will be responsible for creating and maintaining clinical databases and case-report forms (CRFs) for new and ongoing studies. This position will interact closely with the internal Compute and Laboratory teams. Responsibilities
Collaborate with the clinical team in the development, design and implementation of eCRF study databases.
Provide ongoing data management for all clinical studies ranging from multi-center site based clinical trials to coordination of sample collections for an internal biorepository.
Oversee and ensure completion of data management project milestones for all data management deliverables within the scope of project budget and timelines
Communicate effectively with the Whole Biome project manager, clinical team, clinical laboratory, manufacturers of study product and database programmers as well as site based staff when applicable. Lead data focused project team meetings and ensure all stakeholders, statistical programmers, project management, clinical team, are up to date and informed
Manage and oversee the study data entry, data QC and real-time query status of the database to ensure a rapid and successful database lock for clinical trials within specified project timelines
Escalate any issues within a timely manner, ensure creation of intervention strategies, oversee and report back on progress throughout the lifecycle of clinical studies
Communicate with external vendors (CROs, labs etc) and internal database programers to ensure successful integration of all clinical study data.
Assist and provide input into internal data management systems including product inventory and supply systems
Ensure all current relevant regulatory requirements and Good Clinical Practice standards related to data management are met internally as well as clinical site personnel and external vendors.
Provide data focused site training at Investigator meetings and throughout the clinical studies as applicable
Bachelor's degree, preferably in Life Sciences or Biological Science
Certified Clinical Data Manager (CCDM) designation is preferred or equivalent combination of relevant education and/or experience
Thorough knowledge of clinical trial processes from study design through to completion including all regulatory obligations
Strong organizational, planning and critical thinking skills
Ability to work successfully as a self-directed individual, as well as within a cross-functional team
Always willing to take on additional responsibilities if asked
Belief in transparency, open communication and the ability for an individual’s power to improve and enable those around them
Desire to spend your day trying to help others in the company and in the world who are suffering from diseases which may benefit from a microbiome intervention
Desire to work in a cross-functional, collaborative environment that values work/life balance
Email email@example.com with your resume and cover letter to begin the application process. Even if you don't see an opening that fits you, please send us your resume if you think your background and personality would be a great fit!
competitive salary and equity packages
health, dental, and vision
401k with corporate matching
flexible schedules with a focus on work/life balance
unlimited vacation policy (we're all adults and professionals, not clockwatchers)
casual culture (66% of founders usually wearing hoodies)
work/life balance: we believe it, we encourage it, we live it
policies that strongly support maternity / paternity leaves
collaborative, team environment
off-site, team building adventures
walking distance to Caltrain, Muni
walking distance to multiple bars and restaurants in Dogpatch