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:
- conducting phase 2 to 3 of biologics or chemical compound studies;
- using the following tools daily: EDC, eCOA, IRT, CDR, SDTM, data visualization tools, risk based management & TMF; &
- 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 standardization in the pharmaceutical industry.
Work experience may be gained concurrently.
100% Telecommuting permitted
Additional Information
Salary Range: $165,067.99 - $202,500.00 per year.
Apply online at https://careers.abbvie.com/en or send resume to [email protected]. Refer to Req ID: REF44196G
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We offer a comprehensive package of benefits including paid time off (vacation, holidays, sick), medical/dental/vision insurance and 401(k) to eligible employees. This job is eligible to participate in our short-term and long-term incentive programs.
AbbVie is committed to operating with integrity, driving innovation, transforming lives, serving our community, and embracing diversity and inclusion. It is AbbVie’s policy to employ qualified persons of the greatest ability without discrimination against any employee or applicant for employment because 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, status as a protected veteran, or any other legally protected group status.
AbbVie is an equal opportunity employer and is committed to operating with integrity, driving innovation, transforming lives and serving our community. Equal Opportunity Employer/Veterans/Disabled.
US & Puerto Rico only - to learn more, visit https://www.abbvie.com/join-us/equal-employment-opportunity-employer.html
US & Puerto Rico applicants seeking a reasonable accommodation, click here to learn more:
https://www.abbvie.com/join-us/reasonable-accommodations.html
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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: i...
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