Senior Manager Data Management, OED
AbbVieSouth san franciscoUpdate time: October 21,2021
Job Description
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: The Sr. 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. Identifies and engages 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 and, if assigned, leadership meetings 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, as well as providing input into their development. Qualifications Qualifications: •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. •Must have 8+ years of pharma / clinical research / data management / health care experience or 10+ 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 required. •Demonstrated performance as a cross-functional leader. Demonstrated ability to influence others without direct authority. Demonstrated ability to successfully coach / mentor in a matrix environment. Demonstrated effective communication skills. Demonstrated effective analytical skills. .CRO oversight and vendor management experience preferred. Significant Work Activities N/A Travel No Job Type Experienced Schedule Full-time Job Level Code M 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.
Get email alerts for the latest"Senior Manager Data Management, OED jobs in South san francisco"
