Data Science Program Lead II, Data Management - Oncology
Job 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 www.abbvie.com. Follow [redacted] on Twitter, Facebook, Instagram, YouTube and LinkedIn.
Job Description
- 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 physicians
- Oversee all EDC,and IRT vendor contracts for assigned clinical trials
- Supervise all Data Sciences staff (including equivalent CRO staff) for assigned clinical trials
- Co-represent Data and Statistical Sciences at any meetings with FDA and regulatory agencies regarding assigned clinical trials
- Lead 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 concurrently
- Plan 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 team
- For 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 level
- Interacts with and influences cross-functional team members to achieve program objectives
- Utilizes 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 solutions
- 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. If assigned, participates as the DS study owner in regulatory inspections and internal quality audits
- Participates in oversight of vendors and provides feedback related to clinical trial operations, issues, and trends in performance
- Responsible for coaching and mentoring team members
- Leads DSS innovation and process improvement initiatives and participates in cross-functional initiatives
- Conducts study execution "lessons learned" across functions
- May include indirect supervision of employee as well as supervision of work of contract resources
Other Jobs You May Be Interested In
Remote Data Entry, No Experience, $40/hr, Part-Time
Virtual Assistant, $45/hr, Remote, No Experience, Night Job
Entry-Level Remote Data Entry, $50/hr, Evening Job
Customer Support, No Degree, $40/hr, Remote, Weekend Job
Remote Phone Job, $42/hr, Part-Time, College Student Friendly
Virtual Assistant, $40/hr, Remote, No Degree, Night Job
Part-Time Data Entry, $45/hr, Remote, College Student Friendly
Remote Moderator, No Degree, $50/hr, Evening, Weekend Job
Remote Customer Support, $42/hr, Night Job, No Experience
Live Chat Support, $40/hr, Remote, Entry Level, Part-Time
Virtual Assistant, Remote, $42/hr, Weekend, No Experience
Remote Data Entry, $45/hr, No Degree, Night Shift
Part-Time Customer Support, $40/hr, Remote, College Student
Remote Live Chat, $50/hr, Part-Time, Evening/Night Job
Entry Level Phone Job, $42/hr, Remote, No Degree Required
Weekend Data Entry, $45/hr, Remote, No Experience
Remote Virtual Assistant, $40/hr, Evening, Part-Time Job
Remote Moderator, $42/hr, Part-Time, Weekend, No Degree
Data Entry, $45/hr, Remote, Night Shift, College Student Job
Phone Support, Remote, $50/hr, No Experience, Part-Time
Virtual Assistant, No Experience, $42/hr, Remote, Weekend
Remote Customer Support, $45/hr, Part-Time, College Student
Data Entry, Remote, $40/hr, Night Shift, No Degree
Evening Virtual Assistant, Remote, $45/hr, No Experience
Weekend Customer Support, $42/hr, Remote, College Student
Remote Data Entry, $50/hr, No Experience, Evening/Night Job
Remote Live Chat, $40/hr, Part-Time, No Degree Required
Virtual Assistant, $42/hr, Remote, Weekend, Entry Level
Remote Phone Support, $45/hr, Evening, No Experience Required
Data Entry, No Experience, $50/hr, Remote, College Student
Remote Moderator, $40/hr, Weekend, No Degree, Part-Time
Live Chat Support, Remote, $42/hr, Night Shift, College Student
Phone Job, $50/hr, Remote, No Degree, Part-Time, Weekend
Data Entry, $45/hr, Remote, Evening, No Experience Required
Virtual Assistant, No Experience, $42/hr, Remote, Part-Time
Remote Customer Support, $50/hr, Night Shift, No Degree
Remote Data Entry, $40/hr, College Student Friendly, Part-Time
Live Chat Support, $42/hr, Weekend, Remote, No Degree
Virtual Assistant, Remote, $45/hr, Evening, No Experience
Remote Phone Job, $50/hr, College Student, Night Shift
Remote Moderator, $42/hr, Weekend, No Experience Required
Data Entry, No Degree, $45/hr, Part-Time, Remote Job
Customer Support, $50/hr, Remote, Evening/Night Job, No Degree
Virtual Assistant, $42/hr, Remote, Weekend, No Degree
Remote Live Chat, $45/hr, College Student, No Experience
Remote Data Entry, $40/hr, Part-Time, No Degree Required
Phone Support, $50/hr, Weekend, Remote, No Experience
Virtual Assistant, $42/hr, Evening, Remote, No Degree
Remote Customer Support, $45/hr, No Experience, Part-Time
Data Entry, $50/hr, Night Job, No Degree, Remote
Remote Moderator, $40/hr, College Student Friendly, Part-Time
Virtual Assistant, Remote, $42/hr, Weekend, No Experience
Remote Phone Job, $45/hr, Part-Time, No Degree Required
Customer Support, $50/hr, Night Job, Remote, No Experience
Data Entry, Remote, $42/hr, Evening Job, No Degree
Live Chat Support, $45/hr, Weekend, Remote, College Student
Virtual Assistant, Remote, $50/hr, Part-Time, Night Shift
Data Entry, $40/hr, No Experience, Remote, Weekend Job
Qualifications
- Bachelor's degree in business, management information systems, computer science, life sciences or equivalent. Master's 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 preferred
- Rave experience
- elluminate experience is preferred, but not required
- Demonstrated performance as a functional leader
- Demonstrated ability to influence others without direct authority
- Demonstrated ability to successfully coach / mentor in a matrix environment
- Demonstrated effective communication skills
- Demonstrated effective analytical skills
- Veeva and SpotFire experience preferred
Additional Information
Applicable only to applicants applying to a position in any location with pay disclosure requirements under state or local law:
- The compensation range described below is the range of possible base pay compensation that the Company believes in good faith it will pay for this role at the time of this posting based on the job grade for this position. Individual compensation paid within this range will depend on many factors including geographic location, and we may ultimately pay more or less than the posted range. This range may be modified in the future.
- 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 incentive programs.
Note: No amount of pay is considered to be wages or compensation until such amount is earned, vested, and determinable. The amount and availability of any bonus, commission, incentive, benefits, or any other form of compensation and benefits that are allocable to a particular employee remains in the Company's sole and absolute discretion unless and until paid and may be modified at the Company's sole and absolute discretion, consistent with applicable 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 AbbVie's 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 https://www.abbvie.com/join-us/equal-employment-opportunity-employer.html
US & Puerto Rico applicants seeking a reasonable accommodation, click here to learn more:
https://www.abbvie.com/join-us/reasonable-accommodations.html
