Medical Officer / Clinical Project Manager

Biologics & Medical Device Consulting Group, Inc. is a privately held regulatory, clinical and quality consulting group. We are seeking to hire, on a contract basis, an experienced Medical Officer / Clinical Project Manager to support and lead clinical trial projects. In this role, you will be part of a small elite team that is dedicated to bringing ethical, cutting-edge therapies (medical devices, biologics and pharmaceuticals) that improve patients’ lives. Many of our projects are breakthrough technologies. In this role, you will oversee trial execution, provide clinical and scientific input, manage cross functional study teams, and serve as a key liaison between sponsors, investigators, vendors, and internal stakeholders. Key Responsibilities:Clinical Trial ManagementLead and manage clinical trial projects from start up through closeout. Develop and maintain project timelines, budgets, risk plans, and study milestones. Coordinate site selection, feasibility, initiation, monitoring, enrollment, data review, and closeout activities. Ensure studies are conducted in accordance with the protocol, Good Clinical Practice, applicable regulations, and sponsor requirements. Identify project risks and implement mitigation strategies proactively. Manage study vendors, consultants, clinical monitors, and site facing activities as needed. Medical and Scientific OversightProvide medical and clinical input into study design, protocol development, informed consent forms, case report forms, and study related documents. Review clinical data for medical consistency, protocol deviations, safety trends, and endpoint related issues. Support adverse event and serious adverse event review, escalation, and documentation. Assist with medical monitoring activities and clinical interpretation of study findings. Collaborate with sponsors, investigators, and safety teams to address clinical questions. Medical Device Trial SupportManage clinical studies involving medical devices, diagnostics, digital health tools, or combination products. Support device related risk assessment, adverse device effect review, and protocol specific device accountability processes. Ensure study teams understand device specific requirements, including training, handling, use, and documentation. Support compliance with applicable medical device clinical investigation regulations and standards. Sponsor and Stakeholder ManagementServe as a primary point of contact for sponsors and project stakeholders. Lead project meetings, prepare agendas and minutes, and track action items. Provide regular status reports on study progress, risks, budget, enrollment, and deliverables. Build strong relationships with sponsors, investigators, clinical sites, and vendors. Quality and ComplianceEnsure study documentation is complete, accurate, and inspection ready. Support audit and inspection preparation and responses. Contribute to SOP development, process improvement, and quality initiatives. Maintain awareness of applicable regulatory requirements and industry best practices. QualificationsRequiredMedical degree, advanced clinical/scientific degree, nursing degree, or equivalent clinical research experience. 5 – 10 years of clinical trial management experience, preferably in a CRO, sponsor, or medical device company environment. Demonstrated experience managing medical device clinical trials. Strong understanding of clinical trial operations, GCP, regulatory requirements, and study documentation. Experience with study start up, site management, vendor management, monitoring oversight, data review, and closeout. Ability to manage multiple projects in a small team environment with limited administrative support. Excellent written and verbal communication skills. Strong organizational, problem solving, and stakeholder management skills. PreferredExperience in early feasibility, pivotal, postmarket, or registry studies for medical devices. Familiarity with ISO 14155, FDA medical device trial requirements, or EU MDR clinical evidence expectations. Prior experience in a small CRO or start up environment. Experience reviewing clinical safety data, adverse events, and device related events. PMP, CCRA, CCRP, or equivalent certification is a plus. Key CompetenciesHands on clinical trial leadership Medical and scientific judgment Medical device trial experience Sponsor facing project management Risk identification and mitigation Clear communication and documentation, including public speaking Flexibility in a small company environment Quality focused execution Work EnvironmentThis role is remote. Travel will be required for investigator meetings, site visits, sponsor meetings, audits, and conferences.