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Senior Global Study Start Up Lead / Global Study Start Up Lead (Remote Opportunities)

Employer
AbbVie
Location
United States
Start date
Nov 18, 2022

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Discipline
Clinical, Clinical Project Management, Clinical Trials
Required Education
Bachelors Degree
Position Type
Full time

Job Details

This role can be hired at a Sr. Global Study Start Up Lead or a Study Start Up Lead level, dependent on years of relevant experience; previous work, education, and training.

Purpose: 

The Global Study Start Up Lead (GSSUL) is the single point of accountability for defining start up strategy and executing the global country and site activation plans for a designated Therapeutic area. 

Responsibilities:

  • Providing start up focused strategic input on the study plan, country strategy, start up timelines, site profiles and risk assessments for their assigned TA and/or Indication
  • Establishing global activation plans in partnership with Area Study Start Up Leads (ASULs) and the Primary Site Monitors (PSMs), including risk assessments and mitigation planning
  • Driving alignment with Clinical Trial Submissions and Regulatory on global submission strategy to assure coordination with EC submissions, contract execution and activation planning
  • Driving standardization in global start up process and training, including sharing of best practices and lessons learned
  • Monitoring start up progress against established Start Up KPIs and Milestones
  • Overseeing ASULs and Country Study Start Up Specialist from an operational perspective for their assigned trials or programs
  • Partnering with Clinical Study Leadership and Clinical Site Management TA Leads to facilitate cross-functional communication and collaboration
  • Supporting the development and maintenance of SOPs, tools, and templates for study start up activities
  • Ensuring compliance with corporate and divisional policies and procedures in alignment with worldwide regulations and guidelines
  • Participating in or leading process improvement initiatives, as required
  • Mentoring new or junior Global Study Start Up Leads

Qualifications for Sr. Global Study Start Up Lead:

  • Bachelor's Degree required, degree in health care or scientific field preferred
  • A minimum of 6-8 years of global study start up and clinical project management experience and thorough knowledge of global clinical trial regulations and processes
  • Proven leadership skills in a cross-functional global team environment experience in managing remote/virtual teams, and an ability to influence and align stakeholders, while modeling and driving AbbVie’s leadership attributes.
  • Strong analytical and critical thinking skills and the ability to evaluate complex issues from multiple perspectives and drive smart decision making. Excellent interpersonal skills with the ability to build trust and communicate persuasively and with clarity, flexibility and adaptability to changing requirements.
  • Demonstration of successful start up execution and aptitude for managing multiple priorities in a fast‐paced environment
  • Advanced working knowledge of ICH and GCP guidelines and operational understanding of the global regulatory environment

Qualifications for Global Study Start Up Lead:

  • Bachelor's Degree required, degree in health care or scientific field preferred
  • A minimum of 4-7 years of global study start up and clinical project management experience and thorough knowledge of global clinical trial regulations and processes
  • Proven leadership skills in a cross-functional global team environment , and an ability to influence and align stakeholders, while modeling and driving AbbVie’s leadership attributes.
  • Strong analytical and critical thinking skills and the ability to evaluate complex issues from multiple perspectives and drive smart decision making. Excellent interpersonal skills with the ability to build trust and communicate persuasively and with clarity, flexibility and adaptability to changing requirements.
  • Demonstration of successful start up execution and aptitude for managing multiple priorities in a fast‐paced environment
  • Advanced working knowledge of ICH and GCP guidelines and operational understanding of the global regulatory environment

At AbbVie, we value bringing together individuals from diverse backgrounds to develop new and innovative solutions for patients. As an equal opportunity and affirmative action employer, we do not discriminate on the basis 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, protected veteran status, or any other legally protected characteristic. If you would like to view a copy of the company’s affirmative action plan or policy statement, please email CorpJat_ABV@abbvie.com.


Company

AbbVie’s mission is to discover and deliver innovative medicines 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, eye care, virology, women’s health and gastroenterology, in addition to products and services across its Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com. Follow @abbvie on Twitter, Facebook, Instagram, and YouTube.

Stock Symbol: ABBV

Stock Exchange: NYSE

Company info
Website
Phone
1-800-255-5162
Location
1 North Waukegan Road
North Chicago
Illinois
60064
US

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