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Clinical Study Operations Manager New Boston, MA / Remote

$90k - $110k

CleveMed

Brooklyn, NY
  • Remote job

Beacon Biosignals is transforming precision medicine for the brain, from clinical development to clinical care. For Life Sciences partners, we offer the leading at-home EEG platform for clinical development of novel therapeutics for neurological, psychiatric, and sleep disorders. Our Diagnostics business is building the most comprehensive at-home platform for precision diagnostics, combining EEG and cardiopulmonary signals to deliver reimbursable assessments for sleep and central nervous system disorders. Together, we’re changing the way patients are diagnosed and treated for any disorder that affects brain physiology. As a Clinical Study Operations Manager within the Clinical Study Operations team, you will be responsible for ensuring the successful operational delivery of Beacon’s clinical studies, from startup through close-out. You will work closely with sponsors, project teams, and clinical sites to drive efficient study execution and uphold Beacon’s commitment to quality, compliance, and scientific rigor. You will oversee study startup planning, site onboarding and training, and ongoing operational oversight to ensure studies are executed on time and to the highest standards. Acting as a key operational partner to both sponsors and internal teams, you will proactively identify risks, streamline communication, and maintain alignment across stakeholders. In addition, you will foster a culture of quality within the organization by coaching peers on GCP compliance, documentation discipline, version control, and complaint management, strengthening the team’s collective operational excellence. This is a contract-to-hire individual contributor role, fully remote anywhere in the U.S., and will require up to 10% travel. Beacon’s robust asynchronous work practices ensure a first-class remote work experience, but we also have in-person office hubs available located in Boston, New York and Paris. What success looks like: Collaborate with project teams to implement study startup activities, including communication planning, logistics, development of study documentation, and data configuration. Instill confidence with clients on study operations through start up, maintenance and close out activities. Act as the primary point of contact for clinical sites, ensuring smooth operations and clear communication. Provide training to research sites on the use of Beacon’s devices and study protocols, ensuring proper device usage and data collection. Monitor project progress, ensuring adherence to timelines, protocols, and quality standards. Maintain compliance with Good Clinical Practice (GCP), International Conference on Harmonization (ICH) guidelines, and regulatory standards. Foster a culture of quality within the ClinOps and Scientific teams by coaching peers on GCP requirements, documentation discipline, versioning, and complaint management. Address operational issues promptly, escalating through tools like Zendesk and Asana for resolution. Provide actionable feedback from research sites to inform improvements in devices and workflows. What you will bring: 5+ years of experience in clinical project management or clinical operations roles. Strong organizational and project management skills, with the ability to manage multiple responsibilities effectively. Excellent written and verbal communication skills in English; additional languages are a bonus. A proactive mindset with the ability to identify priorities and anticipate challenges. Meticulous attention to detail, ensuring accuracy in data collection and reporting. Ability to work in a fast paced environment with multiple priorities. Familiarity with GCP, ICH guidelines, and clinical research regulatory requirements. Knowledge of decentralized data collection, compliance and oversight while showing empathy for both patients and sites. A desire to learn more about analytics, statistics, machine learning, and clinical trials. The salary range for this role is $90,000 – $110,000. Salary ranges are determined using current market compensation data for this role and adjusted based on experience, skills, and location. The base salary is one component of the total compensation package, which includes equity, PTO and other benefits. At Beacon, we’ve found that cultural and scientific impact is driven most by those that lead by example. As such, we’re always seeking new contributors whose work demonstrates an avid curiosity, a bias towards simplicity, an eye for composability, a self-service mindset, and - most of all - a deep empathy towards colleagues, stakeholders, users, and patients. We believe a diverse team builds more robust systems and achieves higher impact. Voluntary Self-Identification For government reporting purposes, we ask candidates to respond to the below self-identification survey. Completion of the form is entirely voluntary. Whatever your decision, it will not be considered in the hiringprocess or thereafter. Any information that you do provide will be recorded and maintained in aconfidential file. As set forth in Beacon Biosignals’ Equal Employment Opportunity policy,we do not discriminate on the basis of any protected group status under any applicable law. If you believe you belong to any of the categories of protected veterans listed below, please indicate by making the appropriate selection. As a government contractor subject to the Vietnam Era Veterans Readjustment Assistance Act (VEVRAA), we request this information in order to measurethe effectiveness of the outreach and positive recruitment efforts we undertake pursuant to VEVRAA. Classification of protected categoriesis as follows: A "disabled veteran" is one of the following: a veteran of the U.S. military, ground, naval or air service who is entitled to compensation (or who but for the receipt of military retired pay would be entitled to compensation) under laws administered by the Secretary of Veterans Affairs; or a person who was discharged or released from active duty because of a service‑connected disability. A "recently separated veteran" means any veteran during the three‑year period beginning on the date of such veteran's discharge or release from active duty in the U.S. military, ground, naval, or air service. An "active duty wartime or campaign badge veteran" means a veteran who served on active duty in the U.S. military, ground, naval, or air service during a war, or in a campaign or expedition for which a campaign badge has been authorized under the laws administered by the Department of Defense. An "Armed forces service medal veteran" means a veteran who, while serving on active duty in the U.S. military, ground, naval or air service, participated in a United States military operation for which an Armed Forces service medal was awarded pursuant to Executive Order 12985. Voluntary Self-Identification of Disability Form CC-305 Page 1 of 1 OMB Control Number 1250-0005 Expires 07/31/2029 Why are you being asked to complete this form? We are a federal contractor or subcontractor. The law requires us to provide equal employment opportunity to qualified people with disabilities. We have a goal of having at least 7% of our workers as people with disabilities. The law says we must measure our progress towards this goal. To do this, we must ask applicants and employees if they have a disability or have ever had one. People can become disabled, so we need to ask this question at least every five years. Completing this form is voluntary, and we hope that you will choose to do so. Your answer is confidential. No one who makes hiring decisions will see it. Your decision to complete the form and your answer will not harm you in any way. If you want to learn more about the law or this form, visit the U.S. Department of Labor’s Office of Federal Contract Compliance Programs (OFCCP) website at . How do you know if you have a disability? A disability is a condition that substantially limits one or more of your “major life activities.” If you have or have ever had such a condition, you are a person with a disability. Disabilities include, but are not limited to: Alcohol or other substance use disorder (not currently using drugs illegally) Autoimmune disorder, for example, lupus, fibromyalgia, rheumatoid arthritis, HIV/AIDS Blind or low vision Cancer (past or present) Cardiovascular or heart disease Celiac disease Cerebral palsy Deaf or serious difficulty hearing DiabetesDisfigurement, for example, disfigurement caused by burns, wounds, accidents, or congenital disorders Epilepsy or other seizure disorder Gastrointestinal disorders, for example, Crohn's Disease, irritable bowel syndrome Intellectual or developmental disability Mental health conditions, for example, depression, bipolar disorder, anxiety disorder, schizophrenia, PTSD Missing limbs or partially missing limbs Mobility impairment, benefiting from the use of a wheelchair, scooter, walker, leg brace(s) and/or other supports Nervous system condition, for example, migraine headaches, Parkinson’s disease, multiple sclerosis (MS) Neurodivergence, for example, attention‑deficit/hyperactivity disorder (ADHD), autism spectrum disorder, dyslexia, dyspraxia, other learning disabilities Partial or complete paralysis (any cause) Pulmonary or respiratory conditions, for example, tuberculosis, asthma, emphysema Short stature (dwarfism) Traumatic brain injury PUBLIC BURDEN STATEMENT: According to the Paperwork Reduction Act of 1995 no persons are required to respond to a collection of information unless such collection displays a valid OMB control number. This survey should take about 5 minutes to complete. #J-18808-Ljbffr CleveMed

Vacancy posted 1 day ago
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