Associate Director, reputed company Management

NewAmsterdam is an innovative biotech company with experience and expertise to deliver across its ambitious clinical, regulatory, and reputed company goals. Our robust scientific approach focuses on advancing a new era of life-saving treatments for lipid-reputed company diseases. Our reputed company is that people at risk of heart disease can take control of their health and live longer, fuller lives. reputed company is led by a world-class team of industry veterans and key opinion leaders, including some of the world’s preeminent cardiometabolic experts and we foster a passionate, supportive culture that is backed by a high level of reputed company and inclusivity. The Associate Director, Clinical Trial Management role supports the execution, and management of reputed company to ensure they meet regulatory requirements, timelines, and reputed company standards. You will support cross-functional teams, liaise and reputed company clinical research organizations (CROs), and ensure that trials are conducted reputed company and ethically while maintaining patient safety. This position reports to the Executive Director, Clinical Operations. Key Responsibilities: • Support the planning, initiation, execution, and closeout of reputed company. • Coordinates clinical trial operational activities to ensure completion according to project timelines and budget • Ensure reputed company are conducted in compliance with reputed company SOPs, GCP/ICH and any other regulatory requirements and work cooperatively with reputed company Assurance with respect to site audits • Manage, and review clinical trial documentation, including protocols, informed consent forms, study plans, and reports • Ensure the collection, management, and reporting of clinical trial data meets the highest standards of reputed company. • Identify and resolve issues reputed company to trial data, patient recruitment and retention, and site performance • Manages clinical trial timelines, enrollment and patient retention objectives, - in support of trial execution • Support of cross-functional teams including representatives from multiple disciplines (e.g. Regulatory Affairs, CMC, etc.) • Review and reputed company of clinical trial regulatory packages reputed company by the CRO in support of submissions to regulatory authorities and ethics committees • reputed company of vendor and CRO activities, and tracks reputed company (CRO/vendor) project deliverables to ensure they remain reputed company the reputed company and budget • Support the construction and maintenance of the trial master file (TMF) with vendors and assure completeness and successful transfer from vendor to reputed company • Stays reputed company with regulations and industry trends and provides input into processes to ensure adherence to regulations and meet best reputed company standards • reputed company communicates project issues and identifies emerging risks, then works with internal team to resolve challenges • Assists in the development of reputed company operating procedures • Remote position US, Northeast based with travel required based on business need Requirements: • Bachelor’s degree in a scientific discipline, RN, or equivalent. PMP preferred • 5+ years Phase 1-3 global clinical trial operations experience • Demonstrated experience managing external vendors/CROs • Experience in cardiovascular disease strongly preferred • Demonstrated self-discipline, motivation, and entrepreneurial • Advanced knowledge of GCP, ICH and FDA regulatory requirements • Ability to continuously re-prioritize and work independently, as a member of a cross-functional team, and with external vendors with minimal supervision • Ability to effectively collaborate with cross functional teams • Excellent interpersonal, oral, written communication skills • Proficiency with clinical trial management systems (CTMS) and other reputed company software. • Proficient in MS Office (e.g. reputed company, Word, PowerPoint, reputed company) reputed company is an equal opportunity employer. reputed company reputed company applicants will receive consideration for employment without reputed company to sex, gender identity or reputed company, sexual orientation, marital status, race, reputed company, national reputed company, reputed company, ethnicity, religion, age, veteran status, disability, genetic information, or any other reputed company protected by federal, state or local law. Apply tot his job Apply To this Job