Study Project Manager I/II - Multiple Therapeutic Areas (Remote Opportunities)
AbbVie
California, California, Brazil
há 5 dias
source : BioSpace

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 .

Purpose :

The Study Project Manager is a member of Abbvie clinical development operations (CDO) organization accountable for implementation of one or more phase 1-4 global clinical studies within a therapeutic area.

Study Project Manager is responsible for efficient, and on-time delivery of clinical studies with the highest level of quality in accordance with study budget and in alignment with company objectives.

As team member responsible for bringing the science embedded in a study protocol to life, the Study Project Manager must apply scientific expertise, strategic thinking, analytical skills, global mindset, and innovative solutions to proactively manage study risks and anticipate challenges.

Responsibilities :

  • Plan, conduct and close out of clinical studies in compliance with quality standards (ICH / GCP, Global Regulations, and AbbVie policies and procedures)
  • Lead cross functional study team, Lead Clinical Study Team Meetings, actively manage and track study milestones and critical path activities
  • Provide regular updates on study status and progress to cross functional teams, stakeholders, and governance bodies
  • Development of the clinical study design and associated systems and documents; ICF, eCRF, IRT, CSR, etc.
  • Create the study budget and oversight of financial management of approved budget
  • Vendor selection, management and oversight of external vendors in compliance with AbbVie’s processes and procedures and the applicable regulations
  • Generate study related training for the study team, study sites, and vendors for assigned studies and ensures our CTMS is up to date
  • Proactively anticipate, identify, and address study related issues and opportunities for innovative solutions and best practices
  • Single point of contact and decision maker for operational aspects of the study.
  • Initiate and actively participate in creation of innovative solutions and process improvement initiatives beyond his / her studies.
  • Qualifications

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

    Study Project Manager II :

  • Bachelor’s degree in a life science discipline, or equivalent
  • Must possess problem solving, critical thinking, and analytical mindset
  • 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
  • Must have at least 8 years in Pharma / Biotech / CRO planning and executing global clinical trials
  • Experience overseeing fully outsourced clinical trials or experience at a CRO
  • 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).
  • Study Project Manager I :

  • Bachelor’s Degree or OUS equivalent degree is 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 6 years of Pharma-related / clinical research related experience.
  • Strong background leading oncology clinical trials
  • Experience overseeing fully outsourced clinical trials or experience at a CRO
  • 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.
  • 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 Level Code

    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.

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