Startup Submission Specialist

仕事内容

About AbbVie

AbbVie’s mission is to discover and deliver innovative medicines that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people’s lives across several key therapeutic areas: immunology, oncology, neuroscience, eye care, virology, women’s health and gastroenterology, in addition to products and services across its Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com. Follow @abbvie on Twitter, Facebook, Instagram, YouTube and LinkedIn.

Purpose

Serve as a key member of a strategic start-up function in support of clinical program objectives. Apply project management methodology and tools to facilitate delivery of milestones & activities during study-start up. Support continuous improvement initiatives focused on driving efficient and effective processes to meet trial timelines and organizational objectives.

Responsibilities

• Execute such start up activities as (but not limited to) country and site feasibility, site selection, site activation, informed consent, development, etc.by interfacing with country personnel & affiliates, document management, and sites as needed
• Serve to execute regulatory and IRB/EC submissions; document collection; site contracting; etc via collaborative partnerships with Doc Management , site management and monitoring, Regulatory, legal, and contracting
• Collect and gather benchmarking data across all disease areas/indications in support of business planning; business development; and program planning activities
• Support implementation of study and site start-up initiatives to meet regulatory requirements outside of US (OUS), and maintaining alignment with clinical program timelines to achieve business objectives
  

Qualifications

Qualifications:

• Must have a Bachelor’s Degree in a scientific field. An Associate’s degree/R.N. or equivalent with relevant experience is acceptable
• Must have a minimum of 3 years of hands on experience in clinical study management, ICF/GCP clinical research regulations and local rial start-up and management.
• Must be able to understand the local environment from an operations as well as from a regulatory/GCP perspective.
• Must have experience building effective working relationships across functions and geographic locations
  

Travel

No

Job Type

Experienced

Schedule

Full-time

Job Level Code

IC

Equal Employment Opportunity

At AbbVie, we value bringing together individuals from diverse backgrounds to develop new and innovative solutions for patients. As an equal opportunity employer we do not discriminate on the basis of race, color, religion, national origin, age, sex (including pregnancy), physical or mental disability, medical condition, genetic information gender identity or expression, sexual orientation, marital status, protected veteran status, or any other legally protected characteristic.