Study Management Associate II/III, Oncology Early Development (Remote Opportunities)

About AbbVie
AbbVie’s mission is to discover and deliver innovative medicines 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, eye care, virology, women’s health and gastroenterology, in addition to products and services across its Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com. Follow @abbvie on Twitter, Facebook, Instagram, YouTube and LinkedIn.

This role can be hired at a SMA II or a SMA III level, dependent on years of relevant experience; previous work, education, training, and clinical research capabilities 

Purpose:

Oncology is a key therapeutic area for AbbVie, with a portfolio consisting of three marketed products — Imbruvica, Venclexta, and Empliciti — and a pipeline containing multiple promising new molecules that are being studied in nearly 200 clinical trials in 19 different types of cancer.  AbbVie is expanding its oncology early development pipeline.  More than 1,000 AbbVie scientists, clinicians, and product developers with strong entrepreneurial roots work across these sites. They combine their expertise in small molecules, immuno-oncology, stem cells, and cell-signaling with their knowledge of bispecific antibodies, antibody-drug conjugates (ADCs), and covalent-inhibitor technologies to discover and develop novel cancer treatments.  This position is located at the AbbVie site either in North Chicago, IL or Redwood City, CA.

In Oncology Early Development, the Study Management Associate is responsible for supporting the planning and execution of one or more early phase oncology clinical research studies.  The SMA performs clinical trial related responsibilities and CRO/vendor oversight activities to ensure studies are executed with quality and efficiency, on-time, within budget, and in support of company objectives.          

Responsibilities:

Study Management Associate III:

• Responsible for executing one or more elements of clinical studies in compliance with quality standards (ICH/GCP, Global Regulations, and AbbVie policies and procedures).
• Supports the Study Project Manager in leading the cross functional study team:
• Supports the preparation of Clinical Study Team meetings (Agenda/Minutes)
• Responsible for regular updates to the cross-functional team and stakeholders on study status; ensure our CTMS is up to date
• Supports the development of the clinical study blueprint/protocol and associated systems and documents (Informed consent forms, eCRFs, IRT, CSR)
• Supports the vendor selection, scope development, management and oversight of external vendors in compliance with AbbVie’s processes and procedures and the applicable regulations.
• Responsible for generating the study related training for the study team, study sites, and vendors for assigned studies
• Proactively identify and resolve and/or escalate study related issues
• Participates in process improvement initiatives

 

Qualifications

Qualifications:

Study Management Associate III:

• Bachelor’s Degree or OUS equivalent degree required, typically in nursing or scientific field; Registered Nurse licensure with Associate’s Degree in Nursing with relevant experience is also acceptable.
• Must have at least four years of Pharma-related/clinical research related experience and demonstrated a high level of core and technical competencies.
• Experience working in oncology and/or working with CRO preferred.
• Possesses good communication skills.
• Competent in application of standard business procedures {Standard operating procedures, International Conference on Harmonization {ICH), Global Regulations, Ethics and Compliance).
• Preferred exposure to study initiation through study completion.

Study Management Associate II:

Qualifications:

• Bachelor’s Degree or OUS equivalent degree required, typically in nursing or scientific field; Registered Nurse licensure with Associate’s Degree in Nursing with relevant experience is also acceptable.
• Two years of Pharma-related/clinical research related experience or professional equivalent desired.
• Experience working in oncology and/or working with CROs preferred.
• Demonstrates analytical and critical thinking skills.
• Possesses good communication skills.

 

Significant Work Activities
Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hour day)
Travel
Yes, 10 % of the Time
Job Type
Experienced
Schedule
Full-time
Job Level Code
IC
Equal Employment Opportunity
At AbbVie, we value bringing together individuals from diverse backgrounds to develop new and innovative solutions for patients. As an equal opportunity employer we do not discriminate on the basis 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, protected veteran status, or any other legally protected characteristic.