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 www.
abbvie.
com.
Follow @abbvie on Twitter, Facebook, Instagram, YouTube and LinkedIn.
Job Description
Responsible for executing clinical studies in compliance with quality standards (ICH/GCP, Global Regulations, and AbbVie policies and procedures).
Leader of the cross functional study team; Leads Clinical Study Team Meetings; Project manager for clinical studies leveraging the clinical schedule; manages the critical path and milestones
Responsible for regular updates to the cross-functional team and stakeholders on study status; ensures our CTMS is up to date Responsible for regular updates to the cross-functional team and stakeholders on study status; ensures our CTMS is up to date
Responsible for the development of the clinical study design and associated systems and documents (for example: Informed consent forms, eCRFs, IRT, CSR)
Responsible for study budget creation and oversight of spend against approved budget
Responsible for 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 address and/or escalate study related issues and opportunities for efficiency
Decision maker on operational aspects of study execution
Participates in innovation and process improvement initiatives
Provides direct supervision of study management associate(s) including career development of clinical operations staff and creating an inclusive and innovative environment where staff and studies/programs will succeed
Significant Work Activities -Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hour day)
Qualifications
*Level of the role will be determined based on candidate experience level.
Bachelor’s Degree in nursing, scientific, or equivalent required; Associate’s Degree, R.
N.
, or equivalent with relevant experience is acceptable.
Oncology clinical trial experience is preferred
Must have at least 8 years of Pharma-related/clinical research related experience.
Must have demonstrated a high level of core and technical competencies through management of clinical trials.
Possess good communication skills and demonstrated leadership abilities.
Demonstration of successful coaching and mentoring in a matrix environment; direct people management preferred.
Considered a subject matter expert and competent in the application of Standard Business Procedures (International Conference on Harmonization, Global Regulations, Ethics and Compliance).
Experience in successful study initiation through study completion, primary data analysis and/or in multiple phases of studies (Phase 1-3, 4).
Role may sit remotely anywhere in the United States.
Additional Information
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.
Whatsapp
