Current jobs related to Senior Manager of Clinical Compliance - Waltham, Massachusetts - Eleanor Health
-
Senior Clinical Trial Manager
3 weeks ago
Waltham, Massachusetts, United States Clinical Dynamix Full timeJob SummaryWe are seeking a highly experienced Senior Clinical Trial Manager to lead the execution of clinical studies on schedule and on budget. The successful candidate will be responsible for ensuring studies are conducted efficiently and with quality, adhering to timelines and budget, and in alignment with the company's strategic goals.Key...
-
Clinical Trials Manager
3 weeks ago
Waltham, Massachusetts, United States Clinical Dynamix Full timeClinical Trials ManagerThe Clinical Trials Manager is responsible for leading the execution of clinical studies on schedule and on budget. This role requires a high level of experience, skill, and capacity to manage larger and/or more complex studies, projects, or programs.Accountable for project-related efforts for the delivery of studies or programs that...
-
Clinical Trials Operations Manager
2 weeks ago
Waltham, Massachusetts, United States Clinical Dynamix Full timeThe Clinical Trials Manager role at Clinical Dynamix is a critical position that requires exceptional leadership and management skills. The successful candidate will be responsible for leading the execution of clinical studies on schedule and on budget, ensuring that they are completed to the highest standards of quality and compliance.This role involves...
-
Senior Clinical Project Manager
3 weeks ago
Waltham, Massachusetts, United States Deciphera Pharmaceuticals Full timeJob Title: Senior Clinical Project ManagerDeciphera Pharmaceuticals is seeking a highly skilled Senior Clinical Project Manager to lead the successful execution of clinical trials from protocol conception through the clinical study report. The ideal candidate will have a strong background in clinical trial management, excellent communication and...
-
Senior Legal Counsel
4 weeks ago
Waltham, Massachusetts, United States Wolters Kluwer Full timeJob Title: Senior Legal Counsel - Health Clinical EffectivenessWolters Kluwer is seeking a highly skilled Senior Legal Counsel to join our Health Division's Clinical Effectiveness organization. As a key member of our team, you will provide legal advice and guidance on commercial, contractual, and general legal matters, with a focus on our patient and member...
-
Clinical Trials Manager
3 weeks ago
Waltham, Massachusetts, United States Royalty Staffing Full timeClinical Trials Manager Job DescriptionThe Clinical Trials Manager is a critical role within our organization, responsible for leading the execution of clinical studies on schedule and on budget. This position requires a high level of expertise, skill, and capacity to manage larger and/or more complex studies, projects, or programs.Key...
-
Senior Legal Counsel
4 weeks ago
Waltham, Massachusetts, United States Wolters Kluwer Full timeJob Title: Senior Legal Counsel - Health Clinical EffectivenessThe Health Division of Wolters Kluwer is a fast-growing and innovation-driven healthcare information technology company working on the front lines of clinical care.Our talented team of clinicians, technologists, and product visionaries collaborate to provide advanced solutions that tackle some of...
-
Senior Biomarker Program Manager
1 month ago
Waltham, Massachusetts, United States AbbVie Full timeJob Title: Senior Biomarker Program ManagerAbbVie is seeking a highly skilled Senior Biomarker Program Manager to join our Precision Medicine Biomarker Program Management (BPM) group. As a key member of our team, you will play a critical role in implementing and managing biomarker research in multiple Phase 1-3 clinical trials.Key Responsibilities:Manage...
-
Senior Quality Assurance Manager
3 weeks ago
Waltham, Massachusetts, United States Integrated Resources Full timeJob Summary:As a Senior Quality Assurance Manager at Integrated Resources, you will be responsible for reviewing and approving Master Manufacturing Records, Stability Protocols, and Reports to ensure timely initiation of GMP manufacturing activities. You will also provide quality oversight and guidance to resolve compliance issues for drug substance, bulk...
-
Senior Manager, TMF and Inspection Readiness Expert
2 months ago
Waltham, Massachusetts, United States Dyne Therapeutics Full timeJob SummaryDyne Therapeutics is seeking a highly skilled Senior Manager, TMF and Inspection Readiness to join our clinical operations team. This role will play a critical part in ensuring the quality and integrity of our Trial Master File (TMF) and inspection readiness across all clinical trials.Key ResponsibilitiesManage TMF files, including upload, review,...
-
Senior Manager, Clinical Operations
2 weeks ago
Waltham, Massachusetts, United States Dyne Therapeutics Full timeCompany Overview: At Dyne Therapeutics, we are revolutionizing the field of muscle disease treatment with our cutting-edge FORCETM platform. Our mission is to develop innovative therapeutics that transform the lives of individuals living with genetically driven diseases. With a strong focus on clinical-stage muscle disease development, we are driven to...
-
Senior Manager of Contract Negotiations
1 week ago
Waltham, Massachusetts, United States Dyne Tx Full timeAbout Dyne TherapeuticsDyne Therapeutics is a leading biotech company dedicated to advancing innovative treatments for people living with genetically driven muscle diseases. With its cutting-edge FORCE platform, the company is developing life-transforming therapeutics that address the limitations in delivery to muscle tissue.Location: Waltham, MAThis...
-
Clinical Quality Assurance Manager
3 weeks ago
Waltham, Massachusetts, United States Lyra Therapeutics Full timeJob Title: Manager/Sr. Manager GCP Clinical Quality AssuranceLyra Therapeutics, Inc. is a clinical-stage biotechnology company dedicated to developing innovative, integrated drug and delivery solutions for the localized treatment of patients with chronic diseases. Our mission is to improve patient outcomes and quality of life through cutting-edge technology...
-
Quality and Compliance Specialist
2 weeks ago
Waltham, Massachusetts, United States Mass General Brigham Healthcare at Home Full timeJob SummaryMass General Brigham Home Care is seeking a dedicated Quality and Compliance Specialist to oversee quality and compliance programs in assigned regions. This role is responsible for ensuring clinical documentation is comprehensive and compliant with regulatory requirements for a home health agency.Key ResponsibilitiesOversight of quality and...
-
Senior Director, R&D Quality Assurance Lead
3 weeks ago
Waltham, Massachusetts, United States Apellis Full timeJob OverviewApellis Pharmaceuticals is seeking a highly experienced Senior Director, R&D Quality Assurance to lead the development and implementation of quality strategies for the company's R&D function. The successful candidate will be responsible for establishing and maintaining a robust quality management system that ensures compliance with regulatory...
-
Waltham, Massachusetts, United States Alkermes Full timeJob DescriptionThe Director of Clinical Quality Assurance and Pharmacovigilance is a senior leadership position responsible for overseeing the Clinical Quality Assurance Department and ensuring the quality of Post Marketing Good Pharmacovigilance Practices (GPvP) and Commercial Operations. This role is responsible for developing and implementing strategies...
-
Senior Director Regulatory Affairs
4 weeks ago
Waltham, Massachusetts, United States BioSpace, Inc. Full timeJob Title: Senior Director, Regulatory AffairsJob Summary:Dyne Therapeutics is seeking a highly experienced Senior Director, Regulatory Affairs to join our team. As a key member of our regulatory team, you will be responsible for driving forward our regulatory strategy and operational activities related to our muscle disease programs.Key...
-
Senior Director of Regulatory Affairs
4 weeks ago
Waltham, Massachusetts, United States BioSpace, Inc. Full timeJob Title: Senior Director, Regulatory AffairsJob Summary:Dyne Therapeutics is seeking a highly experienced Senior Director, Regulatory Affairs to drive forward our regulatory strategy and operational activities related to our muscle disease programs. The ideal candidate will have a strong background in regulatory strategy, excellent interpersonal skills,...
-
Senior Data Engineer
4 weeks ago
Waltham, Massachusetts, United States Senior Data Engineer Full timeSenior Data EngineerWe are seeking a highly skilled and autonomous Senior Data Engineer to join our team at Scipher Medicine. As a key member of our data infrastructure team, you will be responsible for designing, developing, and maintaining our data ingestion processes into Data Warehouses and other data pipelines.Key Responsibilities:Design and develop...
-
Clinical Trial Manager, Site Start-up
3 weeks ago
Waltham, Massachusetts, United States Viridian Therapeutics Full timeJob SummaryAs a Clinical Trial Manager, Site Start-up at Viridian Therapeutics, you will play a critical role in leading the start-up process for clinical trials. Reporting to the Director/Senior Director of Clinical Operations, you will be responsible for overseeing the end-to-end start-up, site initiation, and site activation process for multiple complex...
Senior Manager of Clinical Compliance
2 months ago
Eleanor Health is seeking a highly skilled Senior Manager of Clinical Compliance to lead our clinical compliance efforts. As a national leader in achieving and maintaining licensing and accrediting, you will be responsible for building and maintaining relationships with external entities, partners, auditors, surveyors, and payers.
Key Responsibilities- Serve as a subject matter expert on licensing and accreditation requirements for Eleanor Health's clinical care delivery into new and established markets.
- Build and maintain relationships with external entities, partners, auditors, surveyors, and payers.
- Collaborate with internal department leaders to ensure compliance with regulatory requirements.
- Directly supervise and support the Clinical Compliance team of Analysts and Coordinators.
- Manage acquisition and maintenance of all clinic or state licenses, accreditations, and certifications.
- Lead the organization in its awareness and understanding of federal guidelines, state regulations, and certification standards.
- Partner with the Sr. Director of CQCM to inform Clinical Compliance strategy and KPIs.
- At least five years of experience in healthcare compliance and management.
- Experience with CARF accreditation.
- Expertise in navigating multi-state licensure landscapes.
- Experience with policy and procedure management tools and technology solutions.
- Strong interpersonal skills and effective communication.
- Meticulous attention to detail and excellent organizational skills.
- Total target compensation range: $100,000 - $125,000 per year.
- Generous benefits package, including vacation time, wellness time, medical and dental insurance, 401(k) plan, short-term disability, long-term disability, life insurance, and family medical leave.
About Eleanor Health
Eleanor Health is a best-in-class substance use disorder (SUD) care provider, utilizing Medication for Addiction Treatment, behavioral health therapy, and broader wellness and social support. We deliver accessible, evidence-based, and clinically excellent care supported by innovative technology, as a multi-site clinical provider. Our mission is to help anyone affected by addiction live an amazing life.