Clinical Trial Manager

By March 26, 2020 Careers

We are seeking an experienced Clinical Trial Manager to serve as the operational project lead for Alpine’s first-in-class novel immunotherapeutic for the treatment of autoimmune and inflammatory disease. This individual’s primary responsibility is to oversee a Phase I/II clinical trial in acute graft-versus-host disease, including project planning, budget and resource management, and oversight of the Contract Research Organization and project vendors. This person works closely with Alpine’s Medical Director to lead a cross-functional team to ensure the timely, quality conduct of clinical studies according to protocols, Good Clinical Practice, Standard Operating Procedures, and all applicable regulations.

Key Responsibilities:

  • Manages clinical operational plan and incorporates the study and scientific plan
  • Oversees clinical trial staff and manages all aspects of clinical operational plan
  • Aligns study start-up, enrollment, study conduct, and close-out activities with project goals and timelines
  • Works closely with the project team to develop the clinical trial protocol and design all associated clinical forms, including Case Report Forms, SAE Forms, etc. for assigned clinical trial
  • Ensures compliance with good clinical practices, good manufacturing practices, and global regulatory guidelines
  • Recommends and implements innovative processes to improve and impact clinical trial management and deliverables
  • Oversees the development of study plans and manuals, and conducts internal team meetings
  • Works closely with the medical director and CRO to plan and execute investigator meetings
  • Helps develop and manage clinical budgets, contracts, and contingency plans for clinical trials
  • Works with the biometrics group to create and implement study-specific tools to ensure clean data and timely data entry
  • Responsible for managing full scope of study, protocol, and clinical study report
  • Acts as a cross functional liaison to ensure study plan aligns with business development strategies
  • Responsible for managing overall study budget, including review of vendor invoices for accuracy

Desired Skills and Experience:

  • University degree and a minimum of 6 years of clinical trials experience in pharmaceutical, biotech, or CRO setting and clinical trial management experience
  • Related experience in drug development, and on-site monitoring or an equivalent combination of education and experience
  • Experience in Phase I-III clinical trials
  • Demonstrated successful management of CROs
  • Inflammatory disease, GVHD, and/or oncology clinical research experience preferred
  • Proven interpersonal skills with the ability to work collaboratively as a member of a cross-functional teams
  • Excellent communication and organizational skills and the ability to work effectively in a high paced, fast changing environment
  • Thorough knowledge of CFR and GCP/ICH requirements
  • Exceptional attention to detail
  • Proficiency with MS Office products Word, Excel, PowerPoint, SharePoint

 

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

Alpine is committed to creating a diverse environment and is proud to be an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, gender, gender identity or expression, sexual orientation, national origin, genetics, disability, age, or veteran status. Alpine is also committed to compliance with all fair employment practices regarding citizenship and immigration status.