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Senior Clinical Project Associate

Company: Pharmacyclics, an Abbvie Company
Location: Sunnyvale
Posted on: April 18, 2019

Job Description:

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.

More than 1,200 Pharmacyclics and AbbVie research scientists, clinicians, marketing, operations and corporate professionals work in the San Francisco Bay Area. They 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.
To learn more about us, please visit us at
General Position Summary:
The Senior Clinical Project Associate (Sr. CPA) is responsible for assisting with clinical trial management, site management, data review and cleaning, and occasionally leading the planning and development of the study setup, execution, and may assist with oversight of clinical study while ensuring the trial is conducted in compliance with the protocol, ICH/GCP, applicable regulatory requirements and applicable SOPs/Work Instructions.
Key Accountabilities/ Core Job Responsibilities:

Study Planning and Conduct:

  • Able to manage CRO and third-party vendors including selection, day to day management of delegated tasks and general oversight by effectively planning resources, activities, manage risk and issues across a region(s)
  • Demonstrates command of site management across various study region(s)
  • Supports and occasionally leads the development/review of clinical study plans, presentations or project/study-related documents including ICF, CRFs, CRF Completion Guidelines, Study Plans, Laboratory Manual, Patient Diary, Study Reference binders, Pharmacy Manual, and Clinical Data Review Plan
  • May provide oversight of CRO activities regarding country and site specific informed consent documentation tracking, finalization and approval.
  • Responsible for coaching and training others on aspects of trial execution
  • Understands importance of, and can lead, implementations to prepare for inspection - including audit plans and processes
  • Demonstrates understanding of study protocol objectives, methodology, biostatistical concepts and data analysis as needed for effective study execution
  • Understands the country-specific variations in regulations and guidelines and the impacts on trial execution
  • Capable of leading delegated portions of documentation efforts to support regulatory filings
  • Tracking of protocol deviations and the overall site management ensuring compliance with Good Clinical Practices (GCP) and applicable regulations and tracking of site performance metrics
  • Lead or assist with TMF processes: set-up, training, QC, management
  • Manages the ongoing tracking of IND Safety Reports for assigned sites and works with CRAs to support drug safety with resolution of open queries
  • Reviews monitoring trip reports and track resolution of all action items and all deviations are acted on with preventative action in place
  • Responsible for the development and distribution of study newsletters, tracking and reporting of recruitment updates
  • Provides input and coordinates the delivery of clinical trial supplies in collaboration with the clinical supply team as well as contribute to the set-up of IRT system, as applicable. Adept at providing oversight of global drug accountability and forecasting
  • Accurately and effectively communicate study needs, issues, and project status with necessary groups and individuals (Manager, Study Teams, etc.)
  • May perform Sponsor quality oversight of clinical staff or CRO performance adherence to GCP, corporate SOPs and protocol as needed Project Management:
    • Collaborates with internal cross functional teams (i.e., Clinical Science, Biometrics, Regulatory Affairs, etc.), and understands other functional objectives and obtain and share information necessary to meet study deliverables
    • Solid understanding and independent execution of project management principles, tools and technique
    • Demonstrates emerging ability to balance quality and timeliness
    • Able to facilitate small and large meetings across functions and vendors while promoting collaboration and accomplishing meeting objectives Financial Planning and Management:
      • Provides support to the CTM in the development and management of vendor scope of work (SOW) per contract, quality, budget, and detailed timelines including investigator and vendor payments
      • May reviews/approves vendor invoices and manages accruals and payment process for all clinical trial vendors including investigative sites
      • Actively manages project management trade-offs among scope, timelines, budget/resources and quality and drives team toward accountability in these areas General:
        • Maintains completion of required corporate training on standards, policies, work instructions by due date
        • Demonstrates a focus on overall operational efficiency, including ensuring that study practices are in compliance with SOPs and inefficiencies are identified, acted on, and communicated to teams
        • Performs other work-related duties as assigned Qualifications/Core Competencies:
          • Demonstrates robust knowledge of GCP guidelines/ICH/FDA regulations and their impact on each stage of the trial (start-up through close-out)
          • Ability to work on complex or multiple projects and exercise critical thinking with minimal
          • Has a strong track record of meeting commitments and delivering high quality work on time
          • Provides context and identifies and articulates key messages effectively and at the appropriate level of detail as well as ensuring communications move across the organization so everyone has the information needed to be effective and efficient
          • Demonstrates a clear understanding of the critical path activities and deliverables and can distinguish between critical and non-critical priorities, creating plans and delegating tasks to team members/external partners/vendors appropriately based on risk, critical path and capability
          • In a team environment or when facilitating meetings, creates an inclusive, collaborative environment that promotes co-creation, open dialogue, and decision making --,---Strong track record of leading multiple work streams to completion with little or no issue escalation
          • Demonstrates ability to compare and find the optimum solutions, looking beyond the obvious toward innovative approaches, avoiding biases and historical crutches as well as being skilled at coping with ambiguity including an ability to act without full information and demonstrating ease in dealing with risk and uncertainty
          • Proficiency in Computer skills including Microsoft Word, Excel, PowerPoint, and organization tools
          • SharePoint experience and filing systems experience is desirable Education and Experience:
            • Bachelor's Degree or equivalent is required, typically in nursing or scientific field; Associate's Degree, R.N. or equivalent with relevant experience is acceptable
            • Must have 5+ years of clinical trial experience in a pharmaceutical, biotechnology, CRO/clinical research related experience and demonstrated a high level of core and technical competencies
            • 3+ years site monitoring experience preferred --,---Experience with outside vendors (e.g., CROs, IRT, Radiology) is preferred --,---Experience in oncology preferred
            • Experience in global trials preferred #featuredjob
              Equal Opportunity Employer Minorities/Women/Veterans/Disabled

Keywords: Pharmacyclics, an Abbvie Company, Sunnyvale , Senior Clinical Project Associate, Healthcare , Sunnyvale, California

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