Onduo is seeking a clinical research manager for an exciting opportunity to build our clinical research program from the ground up. This position will report to the Director of Medical Affairs be responsible for driving clinical trial execution including planning, implementation and monitoring to ensure trial deliverables are met according to timelines, budget, operational procedures, quality standards, GCP and business guidelines.
Responsibilities and Duties:
Provides input to the clinical development plan, protocols and operational aspects of clinical trial protocols (e.g. develops operational plans for trials)
Project manages setup of Onduo systems and procedures to ensure they meet study requirements and protocols
Trains internal and external research staff and serves as the primary contact and resource for research sites and study coordinators for day-to-day study operations
Provides monitoring oversight including authoring of oversight plan, reviewing monitoring visit reports and perform periodic oversight visits to sites and/or vendors to assess progress and compliance
Ensures accurate tracking and reporting of study metrics, timelines, budget milestones, update of trial information in all trial databases and tracking systems, as applicable
Identifies and/or anticipates operational risks and mitigation plans within assigned clinical trials and escalates issues and recommends contingency plans as necessary
Ensures the trial master file and essential documents are maintained throughout the trial and performs inspection readiness checks throughout the lifecycle of the trial
Performs other related duties which may be inclusive, but not listed in position job description
Experience & Skills:
Experience in clinical trial management and oversight, including large RCTs, and developing clinical trial protocols and preparing IRB submissions
Excellent organizational, interpersonal, and communication skills; ability to communicate effectively, both orally and in writing
Good working knowledge of GCP guidelines and other applicable regulatory guidelines required
Knowledge of diabetes as a therapeutic area preferred
Excellent communication and computer skills (gSuite; Electronic Data Capture Systems).
Minimum of 3+ years of clinical research experience at a Medical Device/Biotech/Pharmaceutical or CRO company, at least 2 years direct clinical study management experience working in a full service outsource model as a clinical trial manager or clinical project manager is required
Bachelor’s degree required, in health or life sciences preferred
Some travel may be required (up to 5% depending on project needs)
In addition to your CV, please submit a cover letter that includes examples in your background where you’ve worked with people to develop clinical protocols, oversee clinical care, facilitate trainings, establish relationships and/or overcome barriers.
Onduo is a joint venture between Verily (Google Life Sciences) and Sanofi with a mission to help people with diabetes to live their lives without the continual friction that this devastating and chronic disease imparts on them and their loved ones. Our precision care management solution leverages a combination of lifestyle and medical interventions delivered to patients at-home over the internet to achieve short-term glucose control and long-term metabolic health. We do this using predictive analytics and machine learning to drive behavior change through an ecosystem approach using hardware, software, and service. Based out of Newton, MA. Onduo is looking to create a great team of talented and motivated people to design and build a company, and product, and to help people with diabetes live their very best lives.