Associate Director, Clinical Trial Management

Job Description: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 budgetEnsure 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 auditsManage, and review clinical trial documentation, including protocols, informed consent forms, study plans, and reportsEnsure 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 performanceManages clinical trial timelines, enrollment and patient retention objectives, - in support of trial executionSupport 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 committeesOversight of vendor and CRO activities, and tracks internal and external (CRO/vendor) project deliverables to ensure they remain within the timeline and budgetSupport the construction and maintenance of the trial master file (TMF) with vendors and assure completeness and successful transfer from vendor to NewAmsterdam PharmaStays current with regulations and industry trends and provides input into processes to ensure adherence to regulations and meet best practice standardsActively communicates project issues and identifies emerging risks, then works with internal team to resolve challengesAssists in the development of standard operating proceduresRemote position US, Northeast based with travel required based on business needRequirements:Bachelor’s degree in a scientific discipline, RN, or equivalent. PMP preferred5+ years Phase 1-3 global clinical trial operations experienceDemonstrated experience managing external vendors/CROsExperience in cardiovascular disease strongly preferredDemonstrated self-discipline, motivation, and entrepreneuriaAdvanced knowledge of GCP, ICH and FDA regulatory requirementsAbility to continuously re-prioritize and work independently, as a member of a cross-functional team, and with external vendors with minimal supervisionAbility to effectively collaborate with cross functional teamsExcellent interpersonal, oral, written communication skillsProficiency with clinical trial management systems (CTMS) and other related software.Proficient in MS Office (e.g. Outlook, Word, PowerPoint, Excel)Salary and Benefits:We offer a competitive base salary, annual bonus, and long-term incentives. In addition, we provide a comprehensive benefits package, including health insurance, dental and vision coverage, term life and disability coverage, and retirement plans.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.

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