Clinical Project Manager, Phase I Studies

NewAmsterdam Pharma Corporation

23h

About The Position

Position Summary NewAmsterdam Pharma 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-human, SAD/MAD, food effect, drug-drug interactions, and early proof-of-concept studies ensuring compliance with SOPs, ICH-GCP, and applicable regulatory requirements while delivering high quality execution on time and within budget. Reports to VP of Clinical Operations Key Responsibilities • Lead operational planning and feasibility assessments for Phase 1 studies • Contribute to protocol development, including dose escalation, PK/PD, biomarker sampling, and specialty assessment planning. • Oversee vendor selection and management including contracting, performance, and budget management (Phase 1 units, bioanalytical labs, specialty testing providers, central labs). • Manage study execution, budget, timelines, risk mitigation, dose‑escalation logistics, and cross‑functional communication. • Oversee pharmacokinetic sampling, specialty assessments (ECGs, Holter monitoring), neurological endpoints, and biomarker collection. • Lead CRO and vendor oversight, ensuring delivery quality and adherence to timelines. • Coordinate safety review committees, data flow, AEs/SAEs, SUSAR management, and inspection readiness. • Support study close out activities including data review, database lock, CSR development, TMF completeness and archiving.

Requirements

• Bachelor’s degree in Life Sciences or related 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, rapid safety reviews).
• Experience managing CROs, vendors, and Phase 1 units.
• 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, Outlook, Word, PowerPoint, Excel), CTMS systems and EDC systems
• Travel up to 10–20%

Responsibilities

• Lead operational planning and feasibility assessments for Phase 1 studies
• Contribute to protocol development, including dose escalation, PK/PD, biomarker sampling, and specialty assessment planning.
• Oversee vendor selection and management including contracting, performance, and budget management (Phase 1 units, bioanalytical labs, specialty testing providers, central labs).
• Manage study execution, budget, timelines, risk mitigation, dose‑escalation logistics, and cross‑functional communication.
• Oversee pharmacokinetic sampling, specialty assessments (ECGs, Holter monitoring), neurological endpoints, and biomarker collection.
• Lead CRO and vendor oversight, ensuring delivery quality and adherence to timelines.
• Coordinate safety review committees, data flow, AEs/SAEs, SUSAR management, and inspection readiness.
• Support study close out activities including data review, database lock, CSR development, TMF completeness and archiving.

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.

What This Job Offers

• Job Type: Full-time
• Career Level: Manager