Study Project Manager (Medical Affairs/Immunology/Oncology)

Key Responsibilities

• Independently lead Medical Affairs + Health Impact (MHI) funded research, including Externally Sponsored Collabs & Non-Interventional Studies (NIS) (single & multi-country) from inception to closure, in compliance with quality standards.
• Support strategic leadership of the Cross-Functional Team.
• Drive deliverables & timelines. Lead & manage meetings with stakeholders.
• Manage vendors, recruitment, CTMS & eTMF.
• Maintain Inspection Readiness.
• Identify, mitigate & manage risks.
• Develop & manage study materials.
• Provide training to stakeholders.
• Support EDC, IRT, & ePRO design specifications, user acceptance testing, plans & key risk indicators, & system management activities.
• Manage IP & study supplies. Support process improvement initiatives & serve as a subject matter expert &/or mentor.

Education & Experience

Must possess a Master's or foreign education equivalent & 2 years of clinical research work experience.

Of work experience required, must have 2 years in each of the following:

1. applying standard quality procedures to MHI research, including SOP, ICH/GCP, Global Regulations;
2. working with ICFs, protocols, & amendments;
3. functioning independently in a matrixed environment with teams in multiple time zones across the globe;
4. using 3 or more of the following clinical trial systems or vendors: EDC, IRT, TMF, ePRO, CTMS, central labs, &/or central imaging;
5. managing meetings (creating agendas, preparing minutes, or presenting);
6. analyzing & evaluating complex issues to accelerate study timelines & enable a well-run study; &
7. ensuring data is clean, documents are accurate to maintain inspection readiness.

Alternatively, would accept a Bachelors or foreign education equivalent & 5 years of clinical research work experience.

Of work experience required, must have 5 years in each of the following:

1. applying standard quality procedures to MHI research, including SOP, ICH/GCP, Global Regulations;
2. working with ICFs, protocols, & amendments;
3. functioning independently in a matrixed environment with teams in multiple time zones across the globe;
4. using 3 or more of the following clinical trial systems or vendors: EDC, IRT, TMF, ePRO, CTMS, central labs, &/or central imaging;
5. managing meetings (creating agendas, preparing minutes, or presenting);
6. analyzing & evaluating complex issues to accelerate study timelines & enable a well-run study; &
7. ensuring data is clean, documents are accurate to maintain inspection readiness.

Work experience may be gained concurrently.  Would accept combination of education, training and work experience.

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

Salary Range: $148,000.00 - $202,500.00 per year.

Apply online at https://careers.abbvie.com/en or send resume to Job.opportunity.abbvie@abbvie.com. Refer to Req ID: REF49790R

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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 and long-term incentive programs.

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.

AbbVie is an equal opportunity employer and is committed to operating with integrity, driving innovation, transforming lives and serving our community.  Equal Opportunity Employer/Veterans/Disabled. 

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