Alpine Immune Sciences : Associate/Senior Clinical Project Manager

Job ID: 1108

We are seeking an Associate or Senior Clinical Project Manager. This person will be responsible for overall coordination and management of clinical trial programs, lead cross-functional teams, and accountable for clinical project deliverables within time, quality, and budget constraints. Title and compensation commensurate with level of experience.

Key Responsibilities:

• Leads cross-functional clinical trial team and proactively manages timeline, milestones, budget, resources, and vendors
• Assesses operational feasibility of projects and studies, recommending plans for execution and/or risk mitigation
• Tracks, reports, and reviews study quality metrics and identifies activities warranted to meet trial goals and timelines
• Oversees, plans, and conducts internal team and investigator meetings
• Identifies, hires, and oversees appropriate CROs and other third party vendors
• Negotiates and manages budget, invoices, and payments with vendors and/or sites
• Reviews clinical data listings and summary tables, generates and resolves queries
• Writes, prepares, and/or contributes to clinical protocols and amendments, ICFs, CRFs, study manuals, and other clinical research documents
• Oversees the identification, selection, and monitoring of investigational sites, including investigations of queries and discrepancies
• May train CRAs and third parties on protocols and practices
• May manage IP accountability, release, and reconciliation
• Maintains and/or oversees the maintenance of the TMF
• Ensures execution of trials according to the study protocol and procedures, SOPs, GCP and regulations

Desired Skills and Experience:

• At least 5 years of clinical project and/or trial management with experience in a pharmaceutical/biotech setting
• First-in-human oncology, bone marrow transplant/GVHD, and/or inflammatory disease trial experience strongly preferred
• Bachelor's degree or equivalent in a science or health-related field. CCRA certification preferred
• Demonstrated success at clinical project management, including excellent presentation skills
• Demonstrated successful management of CROs
• Demonstrated knowledge of ICH/GCP and appropriate regulatory guidelines
• Strong interpersonal and communication skills including attention to detail
• Entrepreneurial, enjoys working in a fast-paced, small-company environment. Ability to function well with volatility, uncertainty, complexity and ambiguity; to take disparate inputs and drive them into one cohesive strategic regulatory decision; to work under pressure, meeting time sensitive deadlines, while maintaining a high level of quality

Alpine team members enjoy competitive salaries, equity participation (stock options), and an excellent benefits package including health and life insurance, a 401(k), and generous paid time off benefits.