Clinical Project Manager, Phase I Studies
Job reputed company:
Position reputed company
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.
Reports to VP of Clinical Operations
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%