Study Project Manager

Conteúdo do emprego

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.

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.

Pharmacyclics is committed to the development and commercialization of novel therapies intended to improve the quality and duration of life and to resolve serious unmet medical needs for cancer patients. Pharmacyclics is a wholly-owned subsidiary of AbbVie (NYSE:ABBV), a global, research-based biopharmaceutical company. Oncology is a key therapeutic area for AbbVie, with a portfolio consisting of three marketed products and a pipeline containing multiple promising new molecules that are being studied in more than 200 clinical trials for over 20 different types of cancer.

Our research scientists, clinicians, marketing, operations, and corporate professionals combine their expertise in 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. Together, we are striving to outsmart cancer.

General Position Summary/Purpose

The Study Project Manager is 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. Contributes 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.

Key Accountabilities/Core Job Responsibilities

• Responsible for executing clinical studies in compliance with quality standards (ICH/GCP, Global Regulations, and AbbVie policies and procedures).
• 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.
  

Qualifications

Education/Qualifications

• Bachelor’s Degree or equivalent degree is required, typically in nursing or scientific field.
• Must have at least 6 years of Pharma-related/clinical research related experience.
• Demonstrates a high level of core and technical competencies through management of various components of clinical trials.
• Possesses good communication skills and demonstrated 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).
  

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.

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.