Sr. Manager, Clinical Data Management

Abbvie, Inc Madison , NJ 07940

Posted 2 months ago

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.

Job Description

Envision working with energetic colleagues and inspirational leaders. Now, place yourself in that mix; leading discussions, asking the right questions and driving results.

What Your New Manager Wants You To Know

The Senior Manager, Clinical Data Management is responsible for leading internal and outsourced Clinical Data Management activities in support of Clinical Research studies, managing the definition of Case Report Form (CRF) requirements, creation of the Data Management Plan, coordination of Centralized Data Review activities (a key component of Risk-Based Monitoring), and is accountable for data integrity, quality, and consistency at Database Lock. The employee must be able to lead data review activities and engage different functional groups leading to active participation in ensuring data integrity and completeness.

Other responsibilities include contribution to the definition of defined company data standards and conventions. Functioning as an advisor for Clinical Data Management activities to all project teams.

Supports development and implementation of departmental Standard Operating Procedures (SOPs) and work practices. May contribute to department and other project budget planning.

The employee must conduct their work activities in compliance with all relevant laws, regulations, and regulatory guidelines as well as all AbbVie policies and procedures. May be required to support inspection readiness activities, as well as participate in sponsor and site inspections.

YOU ARE more than just a title, YOU ARE

First class team player: collaborate across multiple disciplines to ensure compliance and ability to influence cross-functional teams and senior leadership.

You Will

  • Be responsible for the role which includes the management and maintenance of clinical data and interfacing with clinical teams. Provides leadership and content expertise for Clinical Data Management activities from start-up through statistical analysis stage of clinical studies to effectively manage data capture, review, and database lock activities.

    Member of the Protocol Review Team, CRF Review Team, Medical Safety Monitoring Plan Reviewer, member of the Clinical Study Report Review Team, and may perform peer review of Clinical Data Management deliverables as a Peer Data Management Lead. In addition, the incumbent is the key contact for Statistical Sciences and Programming (SSP), Global Clinical Trial Management (GCTM), Global Site Management Operations (GSMO), Global Patient Safety & Epidemiology (GPSE), Clinical Development, and Non-Translational Sciences (NTS).

  • Be responsible for the role which includes participating in the vendor selection process and managing vendors (e.g. CROs, FSPs, Technology Providers, etc.) in accordance with applicable AbbVie processes and procedures.

    Involvement in assessment/re-assessment of vendor capabilities, as necessary. In addition, the incumbent is the key contact for R&D Sourcing and Clinical Vendor Oversight (CVO).

  • Be responsible for the role which includes the implementation of quality, efficient, and consistent approaches to carrying out Clinical Data Management tasks. Drives and contributes to continuous improvement.

    Delivering training to Clinical Data Management and other functions/departments as necessary. Monitors compliance to controlled procedural documents (e.g. SOPs) and proactively addresses gaps in processes or understanding of processes by Clinical Data Management staff.

    Supports Corrective and Preventative (CAPA) Action initiatives as needed. In addition, the incumbent is the key contact for Process, Training, and Continuous Improvement (PTCI) and Global Research & Development Quality (GRDQ).

#LI-PD1

Qualifications

You Bring

  • Bachelor's Degree with a proven level of relevant work experience in Clinical Research, Computer Science, Project Management or related field.

  • Strong knowledge of research and development, clinical trials execution, and understanding of regulatory requirements/guidelines (e.g. ICH, GCP, safety reporting).

  • Strong knowledge and understanding of regulatory guidelines for the use of computerized systems in clinical trials.

  • Strong knowledge of global standards related to clinical data management activities (data standards, database design, coding and coding dictionaries, etc.).

  • The ability to travel up to 15% of time.

In this role, we're looking for a leader who will:

  • Act as an Owner

  • Be Excellence Focused

  • Act as an Influencer

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.



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Sr. Manager, Clinical Data Management

Abbvie, Inc