A growing medical device organization is seeking a Clinical Affairs Manager with a strong background in clinical operations, clinical trial execution, and hands‑on procedural case support. This hybrid role combines traditional trial management responsibilities with in‑procedure clinical support, device training, and field‑based proctoring during an IDE Pivotal Trial. The ideal candidate brings both operational rigor and the confidence to train and support surgical teams in a live procedural environment.Position SummaryReporting to the Director of Clinical Affairs, the Clinical Affairs Manager will oversee clinical trial activities while serving as a field‑based expert for investigational device use. This role ensures study sites receive the training, support, and guidance needed to execute procedures safely, compliantly, and consistently. The position interacts closely with investigators, surgeons, clinical research coordinators, and cross‑functional internal teams.Remote work is supported with regular on‑site case coverage and travel.EducationBA/BS or MS in a related scientific or clinical discipline.Training or strong familiarity with colorectal procedures.RequirementsExperienceMinimum of five years of surgical nursing experience (office‑based, ED, or OR) with strong OR protocol knowledge; colorectal cancer exposure preferred but not required.ORMinimum five years of professional experience in clinical research, clinical operations, or clinical trial management in a regulated environment, including extensive case‑support or proctoring experience.Regulatory & Clinical Trial KnowledgeStrong understanding of GCP (ICH, ISO 14155), FDA regulations (21 CFR Parts 11, 50, 54, 812), TMF requirements, and international clinical research standards.Live Case Support ExpertiseProven success supporting clinical trial teams during live surgical procedures.Ability to serve as in‑procedure technical support and guide surgeons, OR staff, and coordinators.Operating Room ProficiencyComfortable working in the OR during procedures performed under general anesthesia.Device Accountability & TrainingFamiliarity with investigational device tracking, accountability, and oversight.Ability to train surgeons and surgical staff on device use, study protocols, and patient selection criteria.Core CompetenciesStrong organizational skills, attention to detail, and clear communication.Ability to manage multiple competing priorities in a fast‑paced environment.Knowledge, Skills, and AbilitiesFoundational understanding of abdominal anatomy and physiology.Ability to learn and apply clinical protocols, IFUs, and colorectal procedural steps.Strong problem‑solving skills and confidence advising on clinical workflow and device use.Excellent written and verbal communication skills.Proficient in Microsoft Office (Word, PowerPoint, Excel).Familiarity with EDC platforms and clinical data systems.Duties & ResponsibilitiesTrain CRCs, surgeons, and OR staff on patient selection, device use, protocol requirements, and placement techniques per IFU.Provide real‑time, in‑procedure clinical support and proctoring during cases.Support enrollment by assisting sites with subject identification, eligibility assessments, and screening workflows.Serve as a primary field resource for procedural questions, troubleshooting, and escalation.Observe and document procedural performance, device handling, outcomes, and deviations; prepare written summaries and case reports.Monitor site performance and provide feedback on procedural consistency and protocol adherence.Deliver ongoing updates to senior leadership and cross‑functional teams on enrollment progress, case metrics, and clinical insights.Participate in site‑initiation visits, investigator meetings, and refresher trainings.Maintain up‑to‑date knowledge of protocol requirements, device risk profiles, and competitive landscape.Work Environment & TravelRemote flexibility with periodic in‑office engagement (~10%).Ability to travel up to 75% within the U.S. for clinical case coverage, often on short notice.Occasional international travel as required.EOE Statement: Specialist Staffing Group is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or veteran status.In addition to base pay, direct-hire employees may be eligible for client offered benefits such as medical, dental, and vision coverage, and paid leave where required by applicable law. Eligibility may vary based on factors such as location and hire date and is subject to change.To find out more about Real, please visit