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關於 AbbVie

AbbVie 的使命是發現並提供創新藥物,解決當今嚴重的健康問題,同時面對未來的醫學挑戰。除了 Allergan Aesthetics 產品組合中的產品及服務外,我們還致力在幾個關鍵治療領域為人們的生活帶來顯著影響:免疫學、腫瘤學、神經科學、眼科、病毒學、女性健康和胃腸病學。如需瞭解更多有關 AbbVie 的資訊,請造訪我們的網站。在 Twitter、Facebook、Instagram、YouTube 和 LinkedIn 追蹤 @abbvie

Clinical Data Strategy and Operations Program Lead I - Oncology TA

次要 North Chicago, 伊利诺伊州 次要 旧金山, 加利福尼亚州; 新泽西州 職位 ID 2215000 類別 Research and Development 部門 AbbVie
  • 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

  • Bachelor’s (Master’s preferred) degree in business, management information systems, computer science, life sciences or equivalent
  • 2+ years of direct clinical development experience. Phase II and III experience
  • Demonstrated strong leadership competencies with broad business orientation and capability to lead teams in the management and completion of clinical trials. Ability to perform as a leader and key contributor to initiatives and advancement of DSS as an organization.
  • Proven track record of successful studies (delivered on time, within budget, and with high quality)
  • Experience leading process (SOPs, Global Regulations, OEC, Outsourcing) and the application of procedures for the business
  • Demonstrated effective communication skills
  • Ability to develop intermediate knowledge of major concepts of key systems
  • Builds strong relationships with peers and cross functionally with partners outside of team to enable higher performance. Creates a learning environment, opens to suggestions and experimentation for improvement. Embraces the ideas of others, nurtures innovation and manages innovation to reality
  • Learns fast, grasps the 'essence' and can change the course quickly where indicated. Raises the bar and is never satisfied with the status quo

Applicable to California Applicants Only 

  • The below range is the range that we in good faith believe is the range of possible compensation for this role at the time of this posting. We may ultimately pay more or less than the posted range and this range is only applicable for jobs to be performed in California.

This range may be modified in the future. 

  • The salary range is (minimum: _$74,500_ to maximum:_$145,500__) 
  • This job is eligible to participate in our short-term incentive program 
  • This job is eligible to participate in our long-term incentive programs 
  • We offer comprehensive package of benefits including paid time off (vacation, holidays, sick), medical/dental/vision insurance and 401(k) to eligible employees. 
    • 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 discretion unless and until paid and may be modified at the Company’s sole discretion, consistent with the law. 

AbbVie is an equal opportunity employer including disability/vets. 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 disabled veteran, recently separated veteran, Armed Forces service medal veteran or active duty wartime or campaign badge veteran or a person’s relationship or association with a protected veteran, including spouses and other family members, or any other protected group status. We will take affirmative action to employ and advance in employment qualified minorities, women, individuals with a disability, disabled veterans, recently separated veterans, Armed Forces service medal veterans or active-duty wartime or campaign badge veterans. The Affirmative Action Plan is available for viewing in the Human Resources office during regular business hours.


重點工作內容: N/A
出差: No
工作類型: Experienced
工作時間: Full-time
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