AbbVie Inc.
Location
Illinois | United States
Job description
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.
Primary responsibilities include but are not limited to:
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
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 process improvement initiatives, as required
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
Key Stakeholder: Clinical Development, Clinical Study Leadership, Clinical Site Monitoring, Global Site Contracting & Purchasing and Supplier Management, Area and Affiliate Regulatory, Clinical Trial Submissions Group, Legal, Safety, Office of Ethics and Compliance, Clinical Documentation Center, Global Medical Affairs, DDC, Agility and Innovation.
This position can be done remotely anywhere in the US.
AbbVie 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.
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