Program Lead II, Data Management

3 weeks ago

North Chicago, United States AbbVie Full time

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 atwww.abbvie.com. Follow @abbvie onTwitter,Facebook,Instagram,YouTubeandLinkedIn.
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:

Oversee the production of all Data Sciences timelines and deliverables for assigned clinical trials and all DSS-related cross-functional meetings with clinical teams, safety teams and physiciansOversee all EDC,and IRT vendor contracts for assigned clinical trialsSupervise all Data Sciences staff (including equivalent CRO staff) for assigned clinical trialsCo-represent Data and Statistical Sciences at any meetings with FDA and regulatory agencies regarding assigned clinical trialsLead clinical study team in the development of key clinical trial systems, study conduct and study close-out as related to Data and Statistical Sciences (DSS) operational activities. Create and manage Data Sciences communications plan for all assigned clinical trials. Exercises real, but informal authority over Data Sciences study team members daily tasks and timelines.Manages 4 to 7 clinical trial startups concurrentlyPlan and manage all Data Sciences timelines and deliverables for assigned clinical trials.Complete trial-specific Statement of Work (SoW) based on parameters supplied by Master Service Agreement (MSA) for Electronic Data Capture (EDC), electronic Patient Reported Outcomes (ePRO) and Interactive.Response Technology (IRT) vendors for assigned clinical trials.Manage and maintain vendor budgets for assigned clinical trials and process flows and data exchanges with global pharmacovigilance for clinical trial serious adverse events. Manage any internal quality assurance audit for assigned clinical trials.Aligns DSS study teams with program- and study-level strategies. Assigned programs may include programs that are of low complexity and size. For assigned programs and studies, leads the DSS Study Team and represents DS as a member of the cross-functional study teamFor assigned programs and studies, acts as single point of contact and accountable operational lead from DSS. Coordinates associated DSS study teams to meet operational objectives. Engages and connects global functional and cross-functional teams at the study levelInteracts with and influences cross-functional team members to achieve program objectivesUtilizes operational analytics and project management tools to optimize execution of programs and studies, to manage internal and external resources, to track study progress, and to prepare study status reports. Anticipates and identifies issues that could affect timelines or quality and develops options and solutionsEnsures 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. If assigned, participates as the DS study owner in regulatory inspections and internal quality auditsParticipates in oversight of vendors and provides feedback related to clinical trial operations, issues, and trends in performanceResponsible for coaching and mentoring team membersLeads DSS innovation and process improvement initiatives and participates in cross-functional initiativesConducts study execution lessons learned across functionsMay include indirect supervision of employee as well as supervision of work of contract resources

Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hr day) is required
Qualifications

Bachelorsdegree in business, management information systems, computer science, life sciences or equivalent. Masters preferred. PMP Certification or Lean Six Sigma Green Belt desired.Must have 6+ years of pharma / clinical research / data management / health care experience or 8+ years of project management experience (and / or applicable work experience).In-depth understanding of clinical trial processes and clinical technology. Management of a clinical trial from initiation through to completion in a lead role is preferredRave experienceelluminate experience is preferred, but not requiredDemonstrated performance as a functional leaderDemonstrated ability to influence others without direct authorityDemonstrated ability to successfully coach / mentor in a matrix environmentDemonstrated effective communication skillsDemonstrated effective analytical skillsVeeva and SpotFireexperience preferred
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 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.

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