Clinical Data Strategy & Operations Program Lead II (Clinical Data Science & Operations in Immunology R&D)

Company Description

AbbVie's mission is to discover and deliver innovative medicines and solutions 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, and eye care – and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com. Follow @abbvie on Twitter, Facebook, Instagram, YouTube and LinkedIn. 

Job Description

Key Responsibilities

• Lead the DSS Study Team & represent DS as the single point of contact & accountable operational lead to meet operational objectives, deliverables, timelines & quality.
• Utilize operational analytics & project management tools to optimize execution of programs &  studies, to manage internal &  external resources, to track project progress, &  to prepare project status reports.
• Ensure adherence to various regulations, industrial standards, Standard Operating Procedures (SOPs), &  to functional quality standards.
• Participate as the DS study owner in regulatory inspections & internal quality audits.
• Responsible for coaching & mentoring team members.
• Lead DSS innovation & process improvement initiatives & participate/lead in cross-functional initiatives.

Qualifications

Education & Experience

Must have a Bachelor’s degree in Life Science, Nursing, Pharmacy, Computer Science, or foreign educational equivalent & 5 years of clinical data management experience in a pharmaceutical, CRO or biotech company.

Of the experience required, must have 5 years:

1. conducting phase 2 to 3 of biologics or chemical compound studies;
2. using the following tools daily: EDC, eCOA, IRT, CDR, SDTM, data visualization tools, risk based management  & TMF; &
3. applying clinical trial processes, including FDA & EMA regulatory requirements, pertaining to clinical research & industry standards & practices.

Of the experience required, must have 3 years (i) performing as project lead in clinical data management; & (ii) leading implementation of data sta