Alpine Immune Sciences : Associate/Senior Clinical Trial Manager

Job ID: 1109

We are seeking an Associate or Senior Clinical Trial Manager. This person will be responsible for operational management and oversight of clinical trials within the Alpine Immune Sciences portfolio, including protocol concept through clinical study report. Title and compensation commensurate with level of experience.

Key Responsibilities:

• Identifies, hires, and oversees appropriate CROs and other third party vendors
• Identifies, selects, and monitors investigational sites, including investigations of queries and discrepancies
• Negotiates and manages budget, invoices, and payments
• Trains CRAs and third parties on protocols and practices
• Manages IP accountability, release, and reconciliation
• Tracks, reports, and reviews study quality metrics and identifies activities warranted to meet trial goals and timelines
• Reviews clinical data listings and summary tables, generates and resolves queries
• Oversees, plans, and conducts internal team and investigator meetings
• Maintains TMF
• Writes, prepares, and/or contributes to clinical protocols and amendments, ICFs, CRFs, study manuals, and other clinical research documents
• Ensures execution of trials according to the study protocol and procedures, SOPs, GCP, and regulations

Desired Skills and Experience:

• At least 3 years of trial management experience in a pharmaceutical/biotech setting
• First-in-human oncology, bone marrow transplant/GVHD, 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 trial initiation thru completion, including excellent project management 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.