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The Clinical Trial Manager, Site Start-up will lead internal process improvements related to study start up activities to ensure clinical trials are executed with high quality standards in compliance with regulatory requirements, GCP, and company SOPs. This role is based in our Waltham, MA headquarters.
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Develop a Site Initiation Management Plan and coordinate regulatory and ethics committee submissions and perform day to day management of the study start up activities for clinical studies. Responsible for external outreach with KOLs and key clinical trial sites to provide feedback on study feasibility and study start up activities.
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Clinical Trial Initiation Manager will deliver high quality and timely global study start-up. Oversee the informed consent process and translation of study required documents and participate in the development of study start up plans.
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The Clinical Trial Manager, Site Start-up will serve as an expert in study start-up practices by initiating efficient start-up activities and removing obstacles for study teams. Provides internal expertise in the early planning of study start-up to ensure proposed CRO timelines and committed milestones are accurate and achievable.
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Manage study start-up planning, and modeling. Leveraging our team’s expertise in antibody discovery and engineering, we have created a robust pipeline of differentiated investigational therapeutic candidates for well-validated targets.
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Initiates and/or completes regulatory and other forms, such as MassHealth Long-Term Care and DMH/DDS PASSR forms and processes the completed forms with the appropriate agencies. Works collaboratively with the Case Manager, Brewster Ambulance Services Transportation Coordinator and the VPNE care van ambassador to coordinate the various modes of discharge transportation.
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Review of indenture/credit agreement compliance and reporting requirements, including financial covenants and compliance certificatesCoordinate and work with rating agencies to obtain credit estimates for portfolio companiesForecast liquidity and fund-level credit metrics, factoring in expected sources, uses and financing assumptions.
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Monitors and assesses compliance with immunization standards as per BPS and DPH regulations. Reports to: Health Administrator General Description: The substitute school nurse provides skilled nursing care and management of the special needs of students as well as medication administration.
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Administers activities related to Company compliance with the 340B PPA contract and price administration. Assists in the development of policies, procedures and calculation methodologies supporting the 340B and FSS Government Price calculations to ensure ongoing compliance with external and internal requirements and guidance including new law and regulations.
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The Clinical Trial Manager, Site Start-up role plays a significant contribution to the clinical trial execution and ability to meet the corporate study goals for the Company clinical Clinical Trial Manager, Site Start-up will lead internal process improvements related to study start up activities to ensure clinical trials are executed with high quality standards in compliance with regulatory requirements, GCP, and company SOPs. This role is based in our Waltham, MA headquarters.
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You’ll also play a key role in establishing best practices for digital asset management, ensuring legal compliance, and driving strategic initiatives to support Epsilon's business goals. Ensure legal compliance and protect Epsilon from legal risks by ensuring that all digital assets comply with relevant laws and regulations.
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In this capacity, the Case Management Coordinator meets compliance criteria, guidelines and regulatory requirements for patient management, including administering the CMS Important Message in a timely manner under the supervision of the social worker and case manager.
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As a Full Time Associate Director Medical Writing at Beacon Therapeutics (USA) Inc, you will work cross-functionally to play a pivotal role in developing and preparing scientific and regulatory documents for our ophthalmology pipeline.
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Hands-on experience with data monitoring and vendor operations, data collection, data-entry, data-monitoring, data-validation, discrepancy management, data-extraction, and IRB/regulatory requirements.
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Ensure compliance with provisions of ERISA, HIPAA, COBRA, ACA, and other federal and local regulatory requirements. The Benefits and HRIS Specialist administers benefits plans on behalf of the organization with a focus on Leaves Management; advises and maintains compliance for staff on benefits administration and serves as HRIS system administrator focusing on the implementation and integration of the UKG Pro system and user experience across the organization.
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regulatory compliance jobs Title: principal in Newton, MA
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