Senior Manager, EDC Systems Design at AbbVie

AbbVie'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.

Key Responsibilities

• Responsible for ensuring successful delivery against programs & maintaining best in industry resources.
• Manage multiple technology evaluations & implementations for performance improvement & cost reduction by practicing continuous improvement of processes & technology usage.
• Provide strategic input on the analysis of new computerized systems & software used for clinical trial data collection, quality assurance and integrity.
• Define, complete, validate, apply and oversee electronic case report form (ECRF) systems, external data acquisitions, reporting & business intelligence tools including Spotfire, J-Review, SQL, PL-SQL, & SAS.
• Supervise & allocate internal & external resources within the Therapeutic Area.
• Ensure all performance assessment responsibilities are achieved for direct reports by providing training & feedback, resolve personnel issues, and manage talent retention for assigned staff.
• Apply data capture systems and methods as a member of the CRF Review team & complete reports of use in data review & reconciliation.
• Responsible for the performance management of staff.
• Support team in building & maintaining a high performing team, recruitment, onboarding, resource assignment, & development opportunities for staff within responsibility.
• Complete the validation of electronic systems, software & programs applied internally per current regulatory requirements such as 21 CFR Part 11 & ICH- GCP.
• Provide strategic direction, advice & guidance to staff in relation to operations responsibilities & activities by promoting best practice & ensure that objectives are successfully met.
• Manage data capture, review and database lock activities for programming activities from start-up through statistical analysis stage of clinical studies.
• Lead the application of programming standards & conventions.
• Responsible for selecting & managing vendors including CROS, FSP & technology providers.
• Employ experience with clinical database design, data loading, & database modeling concepts such as SAS, SQL, CDASH, SDTM, Medidata RAVE, Python, & Veeva EDC.

Qualifications

Must possess a Bachelors degree or foreign academic equivalent in Computer Science, Information Technology, Electronic Engineering or other technical field plus 5 years of related work experience in clinical research, project management, or similar industrial background.

Must possess experience in the following:

1. defining, completing, validating, applying and overseeing electronic case report form (ECRF) systems, external data acquisitions, reporting & business intelligence tools including Spotfire, J-Review, SQL, PL-SQL, and SAS;
2. completing the validation of electronic systems, software and programs applied internally per current regulatory requirements such as 21 CFR Part 11 & ICH- GCP;
3. managing data capture, review and database lock activities for programming activities from start-up through statistical analysis stage of clinical studies; &
4. clinical database design, data loading, & database modeling concepts such as SAS, SQL, CDASH, SDTM, Medidata RAVE, Python & Veeva EDC.

Up to 10% domestic & international travel required. Position requires work at various & unanticipated work locations throughout the U.S. 100% telecommuting is permissible.

Salary Range: $163,360 - $223,500 per year

Apply online at https://careers.abbvie.com/en. Refer to Req ID: REF24398B.

Additional Information

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 and long-term incentive programs.

AbbVie is committed to operating with integrity, driving innovation, transforming lives, serving our community and embracing diversity and inclusion. It is AbbVies 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.