Company DescriptionAbbVie'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 DescriptionThe Manager, Data Management Oncology Early Development (OED) is a key member of the Data Management and Analysis team responsible for the oversight of data and processes conducted by CROs. This individual will collaborate closely with internal colleagues to ensure data integrity and quality for oncology first in human clinical trials up through clinical proof of concept.Responsibilities:
Manage CROs and other outside vendors for data management activities for OED clinical trials. Provide oversight and feedback related to data management operations, issues, and trends in performance.
For assigned programs, acts as primary contact and accountable operational lead from data management. Coordinates with CRO to meet operational objectives.
Implements project-level data management strategy in partnership with OED functions and translates that effectively to CROs for implementation.
Manage and/or perform data management tasks in adherence with established standards including third party vendor data reconciliation, medical coding processing, protocol deviation collection, query management to identify errors and inconsistencies in clinical data and ensure their resolution.
Interacts with and influences cross-functional team members to achieve program and project objectives for data management.
Represents OED data management in cross-functional forums.
Provide data management input for outsourced clinical trial scope, deliverables, and coordination of internal cross functional review.
Ensure CRO data management adherence to global and federal regulations, and applicable local regulations, Good Clinical Practices (GCPs), ICH Guidelines, and to data management quality standards. Stays abreast of new and/or evolving local regulations, guidelines and policies related to clinical development.
May be responsible for coaching and mentoring team members.
QualificationsQualifications:
Bachelor’s degree in business, management information systems, computer science, life sciences or equivalent. Master’s preferred, PMP Certification or Lean Six Sigma Green Belt desired.
CRO oversight, Electronic Data Capture (EDC) experience required, and vendor management experience preferred.
Must have 6+ years of data management experience.
Must have 6+ years of pharma/clinical research/health care experience or 8+ years of project management experience (and/or applicable work experience).
In-depth understanding of clinical trial processes and involved functional stakeholders, and clinical technology. Management of a clinical trial from initiation through to completion in a lead role is preferred.
Ability to perform as a cross functional leader.
Ability to influence others without direct authority.
Ability to successfully coach/mentor in a matrix environment.
Demonstrated effective communication skills.
Demonstrated effective analytical skills.
Additional InformationApplicable only to applicants applying to a position in any location with pay disclosure requirements under state or local law:
The compensation range described below is the range of possible base pay compensation that the Company believes in good faith it will pay for this role at the time of this posting based on the job grade for this position. Individual compensation paid within this range will depend on many factors including geographic location, and we may ultimately pay more or less than the posted range. This range may be modified in the future.
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 incentive programs.
This job is eligible to participate in our long-term incentive programs
Note: No amount of pay is considered to be wages or compensation until such amount is earned, vested, and determinable. The amount and availability of any bonus, commission, incentive, benefits, or any other form of compensation and benefits that are allocable to a particular employee remains in the Company's sole and absolute discretion unless and until paid and may be modified at the Company’s sole and absolute discretion, consistent with applicable law.AbbVie is an equal opportunity employer and 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.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.htmlSalary: $103,500 - $197,000