Study Project Manager (Medical Affairs/Immunology/Oncology)

Job Title

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.

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.

Qualifications

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:

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

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

Where We Work

Role is primarily site- or office-based but can occasionally be performed remotely. Employees who are site/office-based and can occasionally perform their role virtually work both in the office and remotely*, following the policies and regulations in place at their location. US Employees must be in the office on Tuesday, Wednesday, and Thursday with flexibility to work remotely on Mondays and Fridays. Three days in the office is the minimum; some individuals or teams may require more in-office days due to meetings, business/project needs or their role.