Clinical Operations Manager

4 нед. назад

СШАMiddleOnsite

irb submissionsclinical study managementregulatory coordination

Responsible for planning, execution, and oversight of clinical studies, including managing pilot and pivotal studies for FDA clearance.

The Clinical Operations Manager will play a critical role in the planning, execution, and oversight of ’s clinical studies. This role combines strategic clinical operations leadership with hands-on operational execution , supporting study start-up, site initiation, monitoring, and ongoing study management. This individual will be joining at an exciting time in ’s trajectory, and will be responsible for our pilot studies as well as our pivotal study in support of FDA clearance.
This is an in-person, full-time salaried position .
Lead clinical study start-up and execution for a pivotal, multi-site clinical study
Own IRB submissions and ongoing regulatory coordination
Manage site selection, qualification, initiation, and monitoring
Serve as the primary operational point-of-contact for clinical sites and reference laboratories
Develop and maintain core clinical documentation and templates (e.g. case report forms, source documents, and regulatory binders) to ensure GCP compliance
Track site status, operational milestones, and key deliverables to ensure timely study start-up and patient enrollment
Coordinate external clinical vendors and support contracting and budget-related communications
Track study progress, risks, and milestones, and lead regular status updates with internal stakeholders
Support development of the protocol and preparation of regulatory-facing study materials for IRB submission

Bachelor’s degree in life sciences, nursing, public health, or a related field (advanced degree preferred)
5+ years of experience in clinical operations, clinical research, or clinical trial management
Demonstrated experience with study start-up, IRB submissions, and site initiation
Hands-on experience with site monitoring (on-site and/or remote)
Strong understanding of GCP, ICH guidelines, and clinical trial regulations
Experience working with central labs, CROs, and research sites
Prior involvement in leading or managing diagnostic/medical device clinical trials
Exceptional organizational skills and attention to detail
Ability to work independently in a fast-moving, resource-lean environment
Excellent written and verbal communication skills

Experience building clinical trial infrastructure and teams at early-stage companies
Don’t meet every single requirement? Studies have shown that women and people of color are less likely to apply to jobs unless they meet every single qualification. At we are dedicated to building a diverse and inclusive workplace, so if you’re excited about this role but your past experience doesn’t align perfectly with every point in the job description, we encourage you to apply anyways. You may be just the right candidate for this or other roles!
does not accept unsolicited resumes from recruiters or agencies and we will not be responsible for any fees related to resumes that are unsolicited. Any resume submitted by an agency in the absence of a signed agreement will automatically become the property of , and will not owe any referral or other fees with respect thereto.

is developing a first-in-class in vitro diagnostics platform to transform how diseases are diagnosed. We aim to replace lengthy molecular testing workflows by bringing rapid, high-quality diagnostics closer to the patient. Our mission is to improve patient outcomes – starting with women – through a purpose-built platform that delivers actionable results within a single office visit.
The company is headquartered at The Engine, the premier tough technology incubator in the Kendall Square ecosystem. We are collectively committed to health equity and the design of solutions for underserved populations and low-resource settings. Corporate sustainability – both environmental and social – is at the forefront of our decision making.