Senior Electronic Data Capture (EDC)-Lead ( Hybrid Based in IL, NJ, or CA)

---

Job description

Company Description

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 . on Twitter , Facebook , Instagram , YouTube and LinkedIn .

Job Description

Purpose:

AbbVie Data Science is the best-in-class team within its cross-industry peer group and is responsible for bringing people, process, and technology together to generate business value from clinical trials data. Our operational model is exemplified through execution and innovation. This role is key to ensuring successful delivery against the program- and study-level accountabilities assigned to Data and Statistical Sciences.

Responsibilities:

Drive the Overall eCRF Library Development and Maintenance Project. Proactively Identify, Manage and Deliver Individual Components of Library working with various stake holders.

Develop Process and Tools to Ensure Consistency in Process, Implementation and Quality of CDASH and Abbvie Data Collection Standards.

Actively participates in the development of common data standards and ensures EDC systems designs comply with the standards, as well as with associated protocol requirements. Ensures that the design team utilizes standards.

Establishes and maintains methodology used by the team to design and develop EDC systems, benchmarking against industry standards. Ensures that systems are specified to optimize functionality, end user experience, and data flow. Ensures that the design team meets these expectations.

Ensures that TA- and program-level consistency is achieved by the design team

Accountable for the on-time design and delivery of new clinical systems, integrations between systems, as well any required changes to EDC systems. Utilizes project management tools to track study progress and plan work. Anticipates and identifies issues that could affect timelines or quality and develops options and solutions.

Interacts with and influences DSS and cross-functional team members to achieve program and study objectives. Ensures that assigned work product is synchronized with upstream and downstream dependencies.

Ensures adherence to federal regulations and applicable local regulations, Good Clinical Practices (GCPs), ICH Guidelines, AbbVie Standard Operating Procedures (SOPs), and to functional quality standards. Stays abreast of new and/or evolving local regulations, guidelines and policies related to clinical development.

Responsible for coaching and mentoring members of the team, as well as contributes to their skill development

Leads DSS and cross-functional innovation and process improvement initiatives

Significant Work Activities -Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8-hour day)

Qualifications

Bachelors degree in business, management information systems, computer science, life sciences or equivalent. Masters preferred.

Proven expertise in specialized standards development skills, with an emphasis on raw data standards. Excellent knowledge of industry standards such as CDASH, SDTM and a knack for problem-solving with these tools

Strong project management capabilities and experience mentoring, training, and leading teams.

Must have 5+ years of EDC clinical technology experience. Experience with Veeva CDMS Studio preferred.

In-depth knowledge of clinical trial process. In-depth knowledge of CDASH and SDTM.

Demonstrated performance as a key contributor to initiatives and advancement of the organization.

Demonstrated ability to influence others without direct authority.

Demonstrated ability to successfully coach / mentor in a matrixed environment.

Demonstrated effective communication skills and analytical skills.

Demonstrated logical reasoning and problem solving7

Additional Information

Applicable only to applicants applying to a position in any location with pay disclosure requirements under state orlocal law:

• The compensation range described below is the range of possible base pay compensation that the Companybelieves ingood faith it will pay for this role at the timeof this posting based on the job grade for this position.Individualcompensation paid within this range will depend on many factors including geographic location, andwemay ultimatelypay more or less than the posted range. This range may be modified in thefuture.

• We offer a comprehensive package of benefits including paid time off (vacation, holidays, sick),medical/dental/visioninsurance and 401(k) to eligibleemployees.

• This job is eligible to participate in our short-term incentiveprograms.

• This job is eligible to participate in our long-term incentiveprograms

Note: No amount of payis considered to bewages or compensation until such amount is earned, vested, anddeterminable.The amount and availability of any bonus,commission, incentive, benefits, or any other form ofcompensation and benefitsthat are allocable to a particular employee remains in the Company's sole andabsolutediscretion unless and until paid andmay be modified at the Companys sole and absolute discretion, consistent withapplicable law.

AbbVie is an equal opportunity employer and 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.

US & Puerto Rico only - to learn more, visit

US & Puerto Rico applicants seeking a reasonable accommodation, click here to learn more:

<!– job description page –>