Allergan Sr Mgr, Clinical Data Management in Irvine, California

Sr Mgr, Clinical Data Management

Irvine, California, United States at https://agn.referrals.selectminds.com/jobs/5927/other-jobs-matching/location-only

Jul 10, 2018Post Date

181494Requisition #

Allergan plc (NYSE: AGN) is a bold, global pharmaceutical company and a leader in a new industry model - Growth Pharma. Allergan is focused on developing, manufacturing and commercializing branded pharmaceutical, device, biologic, surgical and regenerative medicine products for patients around the world.

Allergan markets a portfolio of leading brands and best-in-class products for the central nervous system, eye care, medical aesthetics and dermatology, gastroenterology, women's health, urology and anti-infective therapeutic categories. With commercial operations in approximately 100 countries, Allergan is committed to working with physicians, healthcare providers and patients to deliver innovative and meaningful treatments that help people around the world live longer, healthier lives every day.

Allergan is a company that will inspire you to aim high with your ambition. Where you can build bridges all over the world. Where you can power ideas that drive change. And where you will act fast and drive results for customers and patients. Power your future & join our bold team.

Position Overview

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 Allergan policies and procedures. May be required to support inspection readiness activities, as well as participate in sponsor and site inspections.

Main Areas of Responsibilities:

Data Management Lead

  • Responsible for 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.

  • Act as 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).

External Vendor Manager

  • Responsible for participating in the vendor selection process and managing vendors (e.g. CROs, FSPs, Technology Providers, etc.) in accordance with applicable Allergan processes and procedures.

  • Involvement in assessment/re-assessment of vendor capabilities, as necessary.

  • Acts as the key contact for R&D Sourcing and Clinical Vendor Oversight (CVO).

Process Owner/Subject Matter Expert

  • Responsible for the implementation of quality, efficient, and consistent approaches to carrying out Clinical Data Management tasks.

  • Drives and contributes to continuous improvement.

  • Delivers 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.

  • Acts as the key contact for Process, Training, and Continuous Improvement (PTCI) and Global Research & Development Quality (GRDQ).

Requirements

  • 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.).

  • Ability to travel up to 15% of time.

Preferred Skills/Qualification

  • Excellent ability to work in a matrix environment and communicate effectively with different functional groups across the organization.

  • Excellent ability to foster open communication and practice active listening to encourage a collaborative team environment.

  • Excellent ability to foster open communication and practice active listening to encourage a collaborative team environment.

  • Demonstrates a solution oriented approach to problem solving and a “can do” attitude.

  • Note: While this job description is intended to be an accurate reflection of the job requirements, management reserves the right to modify, add or remove duties from a particular job and to assign other duties as necessary and at any time.

Education

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

LI -AL1*

Equal Employment Opportunity Employer

Allergan is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability, or any other protected status.