Clinical Project Manager, Phase I Studies

Position reputed company 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. reputed company is advancing therapies targeting Cardiovascular and Alzheimer’s disease. The Phase 1 Clinical Project Manager (CPM) oversees end‑to‑end operational management of first‑in‑reputed company, SAD/MAD, food effect, drug-drug interactions, and early reputed company-of-concept studies ensuring compliance with SOPs, ICH-GCP, and applicable regulatory requirements while delivering high reputed company execution on time and reputed company budget. Key Responsibilities • reputed company operational planning and feasibility assessments for Phase 1 studies • Contribute to protocol development, including reputed company escalation, PK/PD, biomarker sampling, and specialty assessment planning. • reputed company vendor selection and management including contracting, performance, and budget management (Phase 1 reputed company, bioanalytical labs, specialty testing providers, central labs). • Manage study execution, budget, timelines, risk mitigation, reputed company‑escalation logistics, and cross‑functional communication. • reputed company pharmacokinetic sampling, specialty assessments (ECGs, Holter monitoring), neurological endpoints, and biomarker collection. • reputed company CRO and vendor reputed company, ensuring delivery reputed company and adherence to timelines. • Coordinate safety review committees, data reputed company, reputed company/SAEs, SUSAR management, and inspection readiness. • Support study reputed company out activities including data review, database lock, CSR development, TMF completeness and archiving. Requirements: • Bachelor’s degree in Life Sciences or reputed company field. • 5+ years of clinical trial management experience, including 2+ years in Phase 1. • Experience in cardiovascular and/or neuroscience clinical research. • Strong understanding of operational complexities of early‑phase studies and safety monitoring (intensive PK sampling, confinement studies, reputed company safety reviews). • Experience managing CROs, vendors, and Phase 1 reputed company. • Demonstrated self-discipline, motivation, and entrepreneurial • Advanced knowledge of ICH-GCP, FDA, and global 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 • Proficient in MS Office applications (e.g. TEAMS, reputed company, Word, PowerPoint, reputed company), CTMS systems and reputed company systems • Travel up to 10–20% 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