Research Projects Manager, Nutrition
- Cambridge, MA
- September 24, 2019
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Projects Manager at OpenBiome
Projects Manager, Nutrition at OpenBiome
OpenBiome is the world's first stool bank—a nonprofit organization that is expanding safe access to Fecal Microbiota Transplantation (FMT) and driving groundbreaking clinical research on the human microbiome.
Since launching in 2013 out of MIT, our stool banking service has redefined the standard of care for an emerging field of medicine. When we began, only a handful of clinicians offered FMT, a treatment that has an 85% cure rate for C. difficile, the most common hospital-acquired infection in the country. Today we support FMT programs at over 1,000 medical centers across all 50 states. OpenBiome has delivered more than 50,000 treatments for recurrent C. difficile infection, radically improving the lives of thousands of patients that lack treatment alternatives.
OpenBiome has also emerged as a leading independent research organization. We have developed a pill formulation for FMT, published more than 20 scholarly works and enabled the launch of 30+ clinical trials in indications spanning autoimmune disease, infectious disease, malnutrition, metabolic disease, and obesity, and neuropsychiatric disease, to identify opportunities for microbiome-based health interventions. The research that we enable is at the vanguard of understanding how the microbes in our bodies shape major public health challenges.
Position Summary: The Projects Manager serves as the primary point of contact for a portfolio of clinical and/or non-clinical trials and projects.
Position Responsibilities / Duties:
- Manage and serves as the primary point of contact for a select portfolio of clinical and non-clinical trials in OpenBiome’s Nutrition research program.
- Oversees the daily research operations at the external research site to support the site from site-initiation to study close-out; ensuring that all research is conducted in accordance with the ICH E6 R2 and GCP guidelines.
- Track trial/project progress weekly and provide input on progress reports for external funding agencies; ensure that research deliverables meet regulatory, quality standards, and business requirements and timelines.
- Assess external research site feasibility for participation in sponsored research (via questionnaires, phone calls, site visits).
- Project manages and provide input in protocol & CRF design, local and national regulatory submissions, budget management, data management, contracting, and implementation, investigator training, study closeout.
- Build out study documentation (tools, templates, procedures) for trial/project execution.
- Maintain the trial master file for assigned studies (including regulatory, contracts, meeting minutes, etc.); identify and resolve issues and discrepancies.
- Identify, select, and maintain vendor relationships.
- Independently sets agendas and convenes meetings with the external site(s), documents and disseminates all relevant notes, and stores all relevant documents centrally.
- Convene and finalize material for Data Safety Monitoring Board Meetings.
- Manage external monitoring consultant relationship – including reviewing monitoring reports, working with site to improve processes and training.
- Assist the Program Manager, Nutrition & Infectious Disease to prepare the trial/project budget and schedule.
- Monitor and control expenses within allotted trial/project budget, including preparing invoices for submission to Finance Department.
Skills, Knowledge, Qualifications, and Experience:
- Bachelor’s degree or higher in a scientific or allied health field (or equivalent experience) and at least 2, preferably 3 to 4, years of clinical research experience
- Strong knowledge of research study design and sponsor/research site regulatory obligations (ideally with experience in clinical trials)
- Strong knowledge of ICH E6 R2 and GCP guidelines
- Account Management and Project Management experience preferred
- Familiarity with the science behind microbiome mediated disease intervention
- Driven by data and evidence; constantly looking to apply best practices
- Highly detail-oriented and organized
- Curious and creative self-starter
- Ability to communicate clearly and concisely, in both written and verbal contexts
- Passion, humility, and excitement for to accomplish what needs to be done to meet a great public health need
- Ability to multitask and work in an organized and efficient manner
- Open to receiving both formal and informal feedback from peers and management
- Must be legally eligible for work in the United States
Physical demands and work environment:
The physical demands and work environment characteristics described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
- Physical demands: While performing duties of job, employee is occasionally required to stand for extended periods of time as well as often required to walk, sit, use hands to handle or feel objects, tools, or controls (keyboard); reach with hands and arms; talk and hear. Employee is often required to use a telephone at his/her desk. Employee must occasionally lift and/or move up to 10 pounds.
- Work environment: The noise level in the office is low.
- There is a ~10% travel component to this position
OpenBiome is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, religion, color, national origin, gender, gender identity, sexual orientation, age, status as a protected veteran, status as a qualified individual with disability, or any other legally protected status. All applicants must be able to show proof of eligibility to work in the United States.