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 X, Facebook, Instagram, YouTube, LinkedIn and Tik Tok.
Job Description
AbbVie is committed to being an industry leader in developing inclusive clinical research programs. To do so, we must deliver customer-centric solutions with patients and sites that enable equitable trial access and enhanced trial experiences.
The Clinical Research Associate within the Diversity & Patient Inclusion team is a key support role, assisting the team in the development of best-in-class capabilities that improve the delivery of our clinical trials. This role will support workstreams that aim to drive inclusive patient participation in our trials, expand the investigators and sites we work with and strengthen our understanding of site and patient centricity. There will also be the opportunity to drive and manage the Protocol Feasibility Assessment process, a key initiative for the team. This role will report into the Associate Director, Patient Inclusion Solutions.
Overall Scope:
- Subject matter expert in all aspects of the Protocol Feasibility Assessment process, partnering closely with cross-functional stakeholders to provide project management support, including action item tracking, organization and communication of project materials
- Support the development of the disease assessment component of Diversity Action Plans as well as take an active role implementing the comments/edits from study teams/regulatory body as needed on existing plans.
- Apply project management principles and techniques to plan, organize and execute all required deliverables during the protocol feasibility assessment process from inception through execution, including the moderation and debrief of any live engagements
- Develop detailed study-specific feasibility feedback plans and executive summaries, presenting complex data in a clear and actionable format
- Gather, clean, and analyze external expert study feedback to uncover trends, patterns, and actionable insights; communicate findings, recommendations and risk mitigations to cross-functional stakeholders through feedback plans, executive summaries, and meetings
- Track insight protocol adoption rate with study teams through FDA protocol approval
- Collaborate with cross-functional stakeholders to define external expert requirements, identifying and selecting suitable consultants to provide their feedback based on the scope of the feasibility assessment; manage consultant contracting from setup through contract execution
- Execute against defined objectives and keep management informed of progress and achieved project milestones. Track project progress, update project documentation, and maintain all project files; monitor project risks, issues, and changes, escalating for resolution as necessary
- Ensure progress of projects is regularly shared with team members to ensure any challenges/delays are flagged early
- Demonstrate initiative and be process-oriented, convert goals to tasks and define estimates on time and requirements to achieve goal objectives; adaptability to changing requirements and resourcefulness
- Identify process inefficiencies and recommend enhancements to improve overall process, including insight collection, analysis, and reporting procedures
- Develop and maintain knowledge of current systems (i.e. Vision, Tesla, Veeva Vault etc.) and alignment to existing business processes
- Effectively utilizes available technology including AI tools to execute assigned activities, proactively sharing learnings
Support team as needed through special assignments, initiatives and/or coverage requests
Qualifications
- Bachelors degree required, preferably in a technical, scientific or project management related discipline
- Must have 2+ years of professional work experience, preferably in project management, clinical research, analytics, life sciences or comparable experience; or Masters degree with 1+ years of work experience supporting clinical research, drug development and/or therapeutic area operations
- Accreditation in a project management or process improvement discipline preferred (e.g. Project Management Professional, LEAN Six Sigma, etc.)
- Possess strong critical thinking and analytical skills with the ability to prioritize and multi-task
- Must be self-directed and work well in a fast-paced team environment, be able to work on multiple projects concurrently and meet commitments, possess excellent oral and written communication skills
- Demonstrated leadership traits with an ability to work autonomously, manage ambiguity and influence others without direct authority
- Demonstrated performance as a key contributor to initiatives and advancement of their organization (academic, internships, or in a previous job)
this is a remote opportunity that can be hired anywhere in the US
Additional Information
Applicable only to applicants applying to a position in any location with pay disclosure requirements under state or local law:
- The compensation range described below is the range of possible base pay compensation that the Company believes in good faith it will pay for this role at the time of this posting based on the job grade for this position. Individual compensation paid within this range will depend on many factors including geographic location, and we may ultimately pay more or less than the posted range. This range may be modified in the future.
- We offer a comprehensive package of benefits including paid time off (vacation, holidays, sick), medical/dental/vision insurance and 401(k) to eligible employees.
- This job is eligible to participate in our short-term incentive programs.
Note: No amount of pay is considered to be wages or compensation until such amount is earned, vested, and determinable. The amount and availability of any bonus, commission, incentive, benefits, or any other form of compensation and benefits that are allocable to a particular employee remains in the Company's sole and absolute discretion unless and until paid and may be modified at the Company’s sole and absolute discretion, consistent with applicable law.
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.
US & Puerto Rico only - to learn more, visit https://www.abbvie.com/join-us/equal-employment-opportunity-employer.html
US & Puerto Rico applicants seeking a reasonable accommodation, click here to learn more:
https://www.abbvie.com/join-us/reasonable-accommodations.html