SunnyvaleRecruiter
the smart solution for Sunnyvale jobs

Senior Clinical Project Associate

Company: Pharmacyclics
Location: Sunnyvale
Posted on: May 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 http://www.pharmacyclics.com/

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


              Equal Opportunity Employer Minorities/Women/Veterans/Disabled

Keywords: Pharmacyclics, Sunnyvale , Senior Clinical Project Associate, Healthcare , Sunnyvale, California

Click here to apply!

Didn't find what you're looking for? Search again!

I'm looking for
in category
within


Other Healthcare Jobs


Medical/General Dermatologist Manteca, CA da
Description: Medical/General Dermatologist Manteca, CA da 95336 Medical/General Dermatologist Opportunity North of the Central Valley Area. This Compensation Cannot Be Matched. Lux Dermatology Manteca, CA, USA Full (more...)
Company: Executive Staff Recruiters
Location: Manteca
Posted on: 05/20/2019

Occupational Therapist Travel & Locum - School OT (Turlock,CA)
Description: Occupational Therapist are one of the specialties that have the most difference between staffing agencies in job / travel assignment locations and pay rates Must have 2 yrs of Relevant Experience Current (more...)
Company: HealthCare Traveler Jobs
Location: Turlock
Posted on: 05/20/2019

Physical Therapist / Travel / SNF
Description: PT for Turlock, CA. SNF setting. br br Experienced Physical Therapist treating patients with various conditions this will provide you with a wide range of expertise and career development. br (more...)
Company: MAS Medical Staffing
Location: Turlock
Posted on: 05/20/2019


Health Insurance Agent - 100% commission, remote, free leads, no admin
Description: Health Insurance Agent - 100 commission, remote, free leads, no admin Earn unlimited commission selling health insurance through ASSURANCE, and access our leading-edge insurance sales platform as an (more...)
Company: Assurance
Location: Manteca
Posted on: 05/20/2019

Scientist II / Sr. Scientist I, Toxicology (nonclin & clinical), Pharmacological Sciences
Description: Scientist II / Sr Scientist, Toxicologist / PharmacologistBioMarin's Pharmacological Sciences TeamThe Pharmacology and Toxicology Department at BioMarin is seeking a Scientist Scientist 2 to Senior Scientist (more...)
Company: BioMarin Pharmaceutical
Location: San Rafael
Posted on: 05/20/2019

Family Medicine/Internal Medicine in California (Physician #)
Description: VISTA's client in Northern California is in need of outpatient Family Medicine
Company: Vista Staffing Solutions
Location: Manteca
Posted on: 05/20/2019

Sr. Scientist I, Non Clinical Pharmacology & Toxicology
Description: Scientist II / Sr Scientist, Toxicologist / Pharmacologist br br BioMarin's Pharmacological Sciences Team br br The Pharmacology and Toxicology Department at BioMarin is seeking a Scientist Scientist (more...)
Company: BioMarin Pharmaceutical
Location: San Rafael
Posted on: 05/20/2019

Licensed Physical Therapist (PT)
Description: HumanEdge has partnered with a home health facility in Harrison, AR to hire an experienced Physical Therapist PT for a 13-week assignment ndash possibility to extend after
Company: HumanEdge
Location: Manteca
Posted on: 05/20/2019

Occupational Therapist (OT) Travel Job
Description: Jackson Therapy Partners has immediate travel opportunities for experienced Occupational Therapy professionals OT in the California. br br You'll enjoy an incredibly supportive and ambitious team (more...)
Company: Jackson Therapy Partners
Location: San Rafael
Posted on: 05/20/2019

Travel Labor and Delivery-RN Needed (RN #)
Description: Specialty: Travel RN-Labor and DeliveryLocations: Turlock, CAShift: Night 7p-7aDuration: 13 weeksStart Date: ASAP Job Description ul li Responsible for assisting, supporting and educating women during (more...)
Company: All Medical Personnel
Location: Turlock
Posted on: 05/20/2019

Log In or Create An Account

Get the latest California jobs by following @recnetCA on Twitter!

Sunnyvale RSS job feeds