Global Study Start Up Lead (Remote)

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 @abbvie on Twitter, Facebook, Instagram, YouTube and LinkedIn.

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:

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  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



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  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



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  Driving alignment with Clinical Trial Submissions and Regulatory on global submission strategy to assure coordination with EC submissions, contract execution and activation planning



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  Driving standardization in global start up process and training, including sharing of best practices and lessons learned



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  Monitoring start up progress against established Start Up KPIs and Milestones



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  Overseeing ASULs and Country Study Start Up Specialist from an operational perspective for their assigned trials



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  Partnering with Clinical Study Leadership and Clinical Site Management TA Leads to facilitate cross-functional communication and collaboration



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  Supporting the development and maintenance of SOPs, tools, and templates for study start up activities



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  Ensuring compliance with corporate and divisional policies and procedures in alignment with worldwide regulations and guidelines



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  Participating in process improvement initiatives, as required




 
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Significant Work Activities -Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hour day)

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  Bachelor's Degree required, degree in health care or scientific field preferred



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  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



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   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.



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  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.



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   Demonstration of successful start up execution and aptitude for managing multiple priorities in a fast‐paced environment



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  Advanced working knowledge of ICH and GCP guidelines and operational understanding of the global regulatory environment
   




 
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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.

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. ​

• This job is eligible to participate in our long-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 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.