Global Study Start Up Lead

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Job description

Company 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 . on X , Facebook , Instagram , YouTube , LinkedIn and Tik Tok .

Job Description

The Global Lead, Study Start Up and Maintenance is the single point of accountability for defining startup 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 SSUM Area Leads and SML, including risk assessments and mitigation planning.

Driving alignment with CTS 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 SSUM Area Leads and Specialists from an operational perspective for their assigned trials.

Partnering with CPD and SMM 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.

Qualifications

Qualifications:

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

A minimum of 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 AbbVies 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.

This is a remote opportunity that can be based anywhere in the US

Additional Information

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 AbbVies 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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