Associate Director, Clinical Trials Management
NewAmsterdam is an innovative biotech company with experience and expertise to deliver across its ambitious clinical, regulatory, and commercial goals. Our robust scientific approach focuses on advancing a new era of life-saving treatments for lipid-related diseases. Our vision is that people at risk of heart disease can take control of their health and live longer, fuller lives. Our team 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 integrity and inclusivity.
The Associate Director, Clinical Trial Management role supports the execution, and management of clinical trials to ensure they meet regulatory requirements, timelines, and quality standards. You will support cross-functional teams, liaise and oversee clinical research organizations (CROs), and ensure that trials are conducted efficiently 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 clinical trials.
• Coordinates clinical trial operational activities to ensure completion according to project timelines and budget
• Ensure clinical trials are conducted in compliance with NewAmsterdam Pharma SOPs, GCP/ICH and any other regulatory requirements and work cooperatively with Quality 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 quality.
• Identify and resolve issues related 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 oversight of clinical trial regulatory packages prepared by the CRO in support of submissions to regulatory authorities and ethics committees
• Oversight of vendor and CRO activities, and tracks internal and external (CRO/vendor) project deliverables to ensure they remain within the timeline and budget
• Support the construction and maintenance of the trial master file (TMF) with vendors and assure completeness and successful transfer from vendor to NewAmsterdam Pharma
• Stays current with regulations and industry trends and provides input into processes to ensure adherence to regulations and meet best practice standards
• Actively communicates project issues and identifies emerging risks, then works with internal team to resolve challenges
• Assists in the development of standard 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 related software.
• Proficient in MS Office (e.g. Outlook, Word, PowerPoint, Excel)
NewAmsterdam Pharma is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to sex, gender identity or expression, sexual orientation, marital status, race, color, national origin, ancestry, ethnicity, religion, age, veteran status, disability, genetic information, or any other basis protected by federal, state or local law.
Apply Now
Apply Now
The Associate Director, Clinical Trial Management role supports the execution, and management of clinical trials to ensure they meet regulatory requirements, timelines, and quality standards. You will support cross-functional teams, liaise and oversee clinical research organizations (CROs), and ensure that trials are conducted efficiently 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 clinical trials.
• Coordinates clinical trial operational activities to ensure completion according to project timelines and budget
• Ensure clinical trials are conducted in compliance with NewAmsterdam Pharma SOPs, GCP/ICH and any other regulatory requirements and work cooperatively with Quality 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 quality.
• Identify and resolve issues related 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 oversight of clinical trial regulatory packages prepared by the CRO in support of submissions to regulatory authorities and ethics committees
• Oversight of vendor and CRO activities, and tracks internal and external (CRO/vendor) project deliverables to ensure they remain within the timeline and budget
• Support the construction and maintenance of the trial master file (TMF) with vendors and assure completeness and successful transfer from vendor to NewAmsterdam Pharma
• Stays current with regulations and industry trends and provides input into processes to ensure adherence to regulations and meet best practice standards
• Actively communicates project issues and identifies emerging risks, then works with internal team to resolve challenges
• Assists in the development of standard 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 related software.
• Proficient in MS Office (e.g. Outlook, Word, PowerPoint, Excel)
NewAmsterdam Pharma is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to sex, gender identity or expression, sexual orientation, marital status, race, color, national origin, ancestry, ethnicity, religion, age, veteran status, disability, genetic information, or any other basis protected by federal, state or local law.
Apply Now
Apply Now