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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. ·Partners with Clinical Operations, Medical Affairs/local country offices to obtain local insights into country and site selection.
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Responsible for external outreach with KOLs and key clinical trial sites to provide feedback on study feasibility and study start up activities. Clinical Trial Initiation Manager will deliver high quality and timely global study start-up.
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Cross-Functional Collaboration: Collaborate closely with clinical development, translational medicine, biostatistics, regulatory affairs, and external collaborators to integrate biomarker strategies into clinical programs.
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Candidates with experience in the following roles are preferred: Policy Analyst, Policy Associate, Communications Analyst, Communications Associate, Regulatory Affairs Analyst, Regulatory Affairs Associate, Regulatory Analyst, Regulatory Associate.
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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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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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Responsibilities: Manages activities of workers compensation and disability claims, case management and utilization review according to established policies and procedures and applicable legal and regulatory guidelines.
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This individual will interact with clients and help manage projects that require site characterization; due diligence assessments; environmental investigation related to soil, groundwater, and vapor intrusion issues; MassDEP and USEPA regulatory interaction; and field support during site development and construction.
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Integrating scientific rationale, regulatory requirements, product development plan and commercial goals to optimize clinical study designs aligned with the Integrated Development Plan (IDP) and CDP.
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Maintain data integrity in compliance with GCP, relevant SOPs and regulatory requirements by reviewing data processes and filing documentation in the trial master file (TMF) Maintain data integrity in compliance with GCP, relevant SOPs and regulatory requirements by reviewing data processes and filing documentation in the trial master file (TMF.
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The Senior Director, Model Validation for Santander US Compliance models (Transaction Monitoring, Sanctions Screening, Fraud Risk, etc) will be responsible for leading the independent validation of models used by various Compliance groups in conformance with regulatory guidance on model risk SR11-07 and other regulatory requirements around Compliance models.
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Work closely with Global Treasury and Enterprise Risk Management (ERM) to ensure regulatory exposures accurately reflect the Financing Solutions and Foreign Exchange business models. Work with senior analysts to develop and produce Basel III, Stress Tests and other regulatory exposures.
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This investigation includes but is not limited to a criminal, civil litigations and regulatory review, employment, education, and credit review (role dependent). The FMR LLC Legal Department is seeking to hire an attorney to join the Asset Management, Portfolio Investments Legal team supporting venture capital and equity capital markets transactions on behalf of Fidelity s funds and clients.
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This role will develop strong relationships, collaborate, and interact with various departments (i.e., Quality Operations, Quality Systems, Chemistry Manufacturing, and Controls (CMC), Analytical, Regulatory Affairs, Pharmacovigilance, Procurement), and all levels of management at Akebia to accomplish company objectives.
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regulatory affairs jobs Title: assistant Company: Citi in Boston, MA
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