Manager, Clinical Trial Salary at Ossio Inc BETA

This is a 12-month contract with possibility of extension! Job Title: Clinical Governance Operations Manager Location: Remote, preference to area around Billerica, MA Company: EMD Serono Job Type: Contract Overview: We are seeking a skilled and dynamic Clinical Governance Operations Manager to facilitate and moderate our cross-functional protocol review committee for clinical studies. The role will play a crucial role in ensuring that our clinical study protocols and operational plans (timeline, budget) are reviewed effectively and align with regulatory standards, best practices, as well as corporate objectives. The role will also be involved in management of our medical affairs study governance as well as program and portfolio governance processes. This position requires strong communication skills, a strong understanding of clinical operations processes and the ability to foster collaborative discussions among diverse stakeholders. The ideal candidate will possess strong leadership s

Manager, Clinical Operations SanegeneBio Woburn, MA Company Overview: SanegeneBio is a clinical-stage biotechnology company developing innovative RNAi-based genetic medicines. Our proprietary LEAD™ (Ligand and Enhancer Assisted Delivery) RNAi platform drives a growing pipeline across cardiometabolic and complement-mediated diseases. With R&D operations in Boston, Suzhou, and Shanghai, we are committed to scientific excellence, integrity, and collaboration. Position Overview: We are seeking a highly organized and experienced Clinical Operations Manager to join our dynamic clinical research team. The ideal candidate will possess a robust background in managing clinical trials, particularly in the areas of nephropathies, including IgA Nephropathy (IgAN), C3 Glomerulopathy (C3G), and other related kidney diseases. This role will involve overseeing the planning, execution, and management of clinical trials, ensuring compliance with regulatory requirements, and maintaining high standards of

Sr. Clinical Trial Manager - Contract - Boston, MA Are you looking to drive groundbreaking medical research and make a real impact-join us as a Sr. Clinical Trial Manager and lead the way in advancing clinical trials! Primary Responsibilities: This role involves managing trial start-up, maintenance, and closure while ensuring compliance with ICH-GCP standards and internal policies. You will play a crucial role in maintaining data integrity and quality across projects, working closely with vendors and stakeholders. Skills & Requirements: Experience in leading clinical operations for Neuro and Cell & Gene Therapy trials. Strong understanding of ICH-GCP guidelines and clinical trial regulations. Excellent project management and leadership skills. Ability to manage multiple stakeholders and cross-functional teams. Proficiency in maintaining trial documentation and ensuring inspection readiness. Strong problem-solving skills and ability to propose process improvements. Effective communicati

Location: Bedford, MA (Onsite) Focus: Rare Disease Job Overview: The Clinical Trials Manager oversees moderate-complexity clinical trial execution, ensuring adherence to protocol, budget, and regulations, while addressing issues and supporting process improvements. Primary Job Responsibilities: Oversees Phase 1-3 clinical studies, ensuring adherence to timelines, budgets, and plans with CRO and vendor collaboration. Leads the selection and qualification of Investigators and vendors. Contributes to the development of clinical study protocols and documents. Develops operational plans and maintains timelines through coordination with internal teams. Identifies and mitigates study risks, ensuring alignment with stakeholder expectations. Manages drug supply coordination with CMC for consistent site delivery. Assists in budget management and financial forecasting for resource allocation. Enhances operations through project management skills, improving performance and SOPs. Primary Job Requir

Job Title: Clinical Trial Associate Location: Hybrid- 3 days a week Cambridge Contract Term: 6 months to start; could extend Experience required: Biotech/pharma preferred Position Overview: The CTA position will assist with daily clinical trial execution activities including the coordination of documents associated with the conduct of investigational clinical studies. The CTA will support the Clinical Trial Managers in day-to-day activities including engaging vendors, starting up and managing clinical trials. The ideal candidate will have keen attention to detail and has the ability both to prioritize and handle multiple tasks effectively in a rapidly growing company environment. Key Responsibilities: Organize/maintain tracking systems and set up tools to support the conduct of a clinical study from start-up to close-out Assist with the development and review of clinical documents including protocols, ICFs and clinical study plans Schedule and coordinate study meetings, materials and a

Location: Boston, MA (Onsite) Focus: Oncology Job Overview: In this role, you will spearhead oncology trials, leading from planning through execution, guide junior staff, and collaborate with partners, ensuring efficiency and quality in a dynamic environment. Primary Job Responsibilities: Manage clinical trial timelines, identify risks, and ensure goals are met. Facilitate cross-functional collaboration for trial support. Optimize vendor contracts and performance for trial success. Primary Job Requirements: BA/BS in a life science field with 12+ years in clinical research. Require 2+ years of oncology research experience, 5+ years Biotechnology industry experience Expertise in early phase trials and IND submissions About Stratacuity: Whether you are seeking a career change or simply interested in becoming part of our network, you will appreciate the ethics guiding each Stratacuity team member. We build lasting relationships with exceptional biopharmaceutical talent and take great care

COMPANY OVERVIEW AIRNA is a biotechnology company with a mission to transform lives, one RNA edit at a time. AIRNA is pioneering the discovery and development of RNA editing therapeutics to realize the therapeutic potential of base editing for patients with rare and common diseases. RNA editing modality is poised to lead the next generation of RNA therapeutics by bringing the precision of gene editing technology with a potent and safe medicine that can be conveniently re-dosed and manufactured. Our RESTORE+™ platform is based on groundbreaking research by academic co-founders Thorsten Stafforst (University of Tübingen) and Jin Billy Li (Stanford University), who were the first to elucidate a therapeutic approach for precise editing of RNA. AIRNA has received $90 million in Series A financing from world class venture capital firms, including Forbion and Arch Venture Partners, and is headquartered in Cambridge, MA with research operations in Tübingen, Germany. JOB DESCRIPTION The Head of

Job Responsibilities: Manage assigned clinical studies within a designated budget and timeline. Conduct CRO, Vendor and site assessment and selection; negotiating budget and contracts. Conduct site qualification, initiation, interim monitoring and close-out visits. Collecting and reviewing trial master documentation. Document results of visits in monitoring reports for review and finalization. Facilitate IRB submissions and renewals when needed. Oversee clinical sites, central lab, and other third parties to ensure issues are resolved timely. Motivating investigational sites to close queries and action items. Develop or review clinical project plans and clinical trial documentation. Collaborate with Regulatory to prepare FDA pre-submission and submission packages. Oversee the development of a clinical study database by third party, review and summarize clinical data, perform data analysis and reports. Oversee all study team members training to ensure accurate execution of clinical prot