AbbVie

Senior Manager, Clinical Programming

Employer
AbbVie
Location
Irvine, CA, United States
Posted
Nov 09, 2020
Ref
204809
Required Education
Bachelors Degree
Position Type
Full time
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 Programming is responsible for leading internal and outsourced Clinical Programming activities in support of Clinical Research studies and managing the design, development, validation, implementation, and oversees ongoing support to electronic case report form (eCRF) systems, external data acquisitions, reporting/business intelligence tools (e.g. SpotFire, J - Review), and other programs (e.g. SQL, PL - SQL, SAS). Other responsibilities include providing strategic input into the analysis of new systems and software to support clinical trials data collection, quality, and integrity. Support in the validation of electronic systems, software, and programs implemented internally according to current regulatory requirements. Also leads the implementation of programming standards and conventions. 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 implementation of data capture systems and methods, member of the CRF Review Team, providing ongoing support to data capture, and generation of reports for use in ongoing data review and reconciliation. Provides leadership and content expertise for programming activities from start - up through statistical analysis stage of clinical studies to effectively manage data capture, review, and database lock activities. In addition, the position is the key contact for Clinical Data Management, Research & Development Quality Information Technology (RDQIT), 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).
  • 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).
  • Responsible for the role which includes the implementation of quality, efficient, and consistent approaches to carrying out Clinical Programming tasks. Drives and contributes to continuous improvement. Delivering training to Clinical Programming 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 Programming 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 programming activities (data standards, database design, coding and coding dictionaries, etc.).
  • 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.
  • A solution-oriented approach to problem solving and a "can do" attitude.
  • 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

Job Type
Standard

Schedule
Full-time

Equal Employment Opportunity
At Allergan, 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.