Easter Seals Jobs

Company Description Insmed is a global biopharmaceutical company on a mission to transform the lives of patients living with serious and rare diseases. Our most valuable resource is our employees, and everything we do is motivated by a patients-first mentality. We are dedicated to growing our team with talented individuals from around the world who are willing to challenge the status quo, solve problems, and work collaboratively with a sense of urgency and compassion. Guided by our core values of collaboration, accountability, passion, respect, and integrity, we aim to foster an inclusive, diverse, and flexible work environment, where our employees are recognized for leaning in and rolling up their sleeves. If you share our vision and want to work with the most dedicated people in the biopharma industry, come to Insmed to accelerate your career. Recognitions Consistently Ranked Science 's Top Employer Insmed is dedicated to creating a collaborative environment where our team can thrive. Every day, our employees turn their passion for science and research into innovative solutions for patients. That's why we've been named the No. 1 company to work for in the biopharma industry in Science 's Top Employers survey for four years in a row.A Certified Great Place to Work® We believe our company is truly special, and our employees agree. In July 2024, we became Great Place to Work-certified in the U.S. for the fourth year in a row. We are also honored to have been listed on the Best Workplaces in Biopharma™, Best Workplaces in New York™, PEOPLE® Companies That Care, Best Workplaces for Women™, Best Workplaces for Millennials™, and Best Medium Workplaces™ lists. Overview The Director, Clinical Systems and TMF Operations is a member of the Clinical Business Operations team within the Development Operations organization and is responsible to provide strategic leadership and oversight of Trial Master File (TMF) Operations, Records Management, and Clinical Systems & Technology (CS+T) utilized across clinical programs. This role will serve as the Business Owner for Clinical Systems and TMF Operations and has accountability to oversee the processes and staff within these areas to optimize the operating model, ensure ongoing inspection readiness, and foster a culture of continuous improvement. This role serves as a key leader and partner with internal cross-functional stakeholders and external suppliers to establish and uphold company standards and processes, achieve efficient set-up and implementation, and ensure oversight of systems and documentation across Insmed programs/trials, in compliance with SOPs, FDA regulations, GCP and ICH guidelines. This individual will evaluate evolving industry trends and best practices and assess their impact on current processes, formulate strategies, and lead the implementation of improvement initiatives to advance our business toward progressive ways of working. As a key change agent within the organization, this role will drive change management and promote adoption of enhanced processes, standards, and innovations. Responsibilities Clinical Systems & Technology: * Provides leadership and expertise to build and deliver CS+T strategy and initiatives to support organizational business objectives. * Develops business cases around clinical systems & technology, implements solutions, and measures effectiveness. * Partners with cross-functional team members (e.g., Development Operations, Data Management, Tech Ops/Clin Supplies, QA, IT, Procurement) to identify and select CS+T supplier(s), and ensure effective onboarding and implementation (e.g., qualification, Computer System Validation (CSV), system specifications, UAT). * Responsible for oversight of the CS+T vendors (e.g., IRT/RTSM, eCOA/ePRO) and ensuring both quality and timeliness of their work. * Identifies areas of opportunity, mitigates risks, and provides solutions to identified problems. * Oversees contracting and budget management activities including establishing initial Scope of Work (SOW) and Change Orders, as applicable. * Ensures all QA CSV requirements are met to support system validation and vendor qualification according to Insmed requirements, and per study start-up timelines. * Supports/Oversees kickoff meeting(s) for each respective trial with the system/technology supplier and internal cross-functional team members. * As Business Owner, ensures processes, tools, documents, and training materials related to clinical systems and technology are developed and implemented, as appropriate. * Acts as primary business change agent within Development Operations to ensure adoption of new capabilities and business processes related to clinicaTo view the full job description, click here