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
As Study Project Manager you will be responsible to connect science and operations to bring clinical studies to life through the execution of one or more Phase 1-4 clinical research studies.
Contributing clinical operational strategies to ensure clinical research studies are executed with quality and efficiency, on-time, within budget, and meet company objectives. The Study Project Manager achieves these objectives via scientific expertise, strategic thinking, a global mindset and innovative solutions to address risks and challenges.
Primary responsibilities:
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 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.
Qualifications:
Bachelor's Degree or OUS equivalent degree is required, typically in nursing or scientific field.
Must have at least 6 years of Pharma-related/clinical research related experience.
High level of core and technical competencies through management of various components of clinical trials.
Good communication skills and leadership abilities.
Demonstration of successful coaching/mentoring in a matrix environment.
Competent in application of standard business procedures (Standard Operating Procedures, International Conference on Harmonization (ICH), Global Regulations, Ethics and Compliance).
Preferred exposure in study initiation through study completion in multiple phases of studies (Phase 1-3, 4).
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 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.
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