Jennifer Mccall

Jennifer Mccall Email and Phone Number

Currently on a Professional Sabbatical | Finding Passion and Purpose | Connecting with what Matters
Jennifer Mccall's Location
Greater Wilmington Area, United States, United States
Jennifer Mccall's Contact Details
About Jennifer Mccall

With over 20 years of clinical research drug development experience, I am a seasoned leader supporting the planning and execution of global programs across various therapeutic areas, including infectious disease and immunology. I have successfully managed complex and diverse projects, teams, and vendors, delivering high-quality results on time and within budget. But my real passion is for people; the people I work with, the people I support and mentor, and the people whose lives may see a positive outcome based on the work I support. My interest in clinical research stems from my curiosity and commitment to finding innovative solutions that improve human health and well-being. I am currently on a professional sabbatical, exploring, learning and discovering how I can make a real impact. I am eager to connect with organizations that share my vision and mission of improving health outcomes, always putting patients first, while also supporting employees by giving them the tools they need to deliver.

Jennifer Mccall's Current Company Details

Currently on a Professional Sabbatical | Finding Passion and Purpose | Connecting with what Matters
Jennifer Mccall Work Experience Details
  • Science 37
    Director, Clinical Operations
    Science 37 Oct 2021 - Feb 2024
    Morrisville, North Carolina, Us
  • Takeda
    Clinical Operations Program Lead/Clinical Operations Manager
    Takeda Apr 2021 - Sep 2021
    Tokyo, Jp
  • Takeda
    Associate Director, Clinical Operations Program Lead/Clinical Operations Manager
    Takeda Aug 2018 - Apr 2021
    Tokyo, Jp
    - Develops and leads the program-level operational strategy and planning on assigned programs in close collaboration with strategic partners and other vendors. - Provides program-level sponsor’s operational oversight of our strategic partners and other vendors to ensure the effective execution of the clinical studies on time, with high quality and within agreed budget.
  • Ppd
    Sr. Global Project Manager
    Ppd Aug 2011 - Aug 2018
    Wilmington, Nc, Us
    Responsible for the overall coordination and management of clinical trials from start up through to final deliverables. Works with major functional area leads to identify and evaluate fundamental issues on the project, interpret data on complex issues, make good business decisions and ensure solutions are implemented. Works to ensure that all project deliverables meet the customer’s time/quality/cost expectations. The PM, with support from the Project Management Directors and/or Associate Directors, working in collaboration with other functional area leads, is accountable for ensuring that all project deliverables meet the customer/contract expectations, providing accurate hour forecasts, reviewing pass through costs and ensuring timely invoicing. Oversees all relevant functional areas involved in delivery of PPD services of global clinical trials (NA, EMEA, APAC and LA) based on the contract requirements, while meeting the client’s needs and adhering to the contracts and associated projectbudgets.
  • Ppd
    Sr. Clinical Trial Manager
    Ppd Jan 2007 - Aug 2011
    Wilmington, Nc, Us
    Accountable for achieving the final clinical deliverable within the time period specified in contract with the Customer. Responsible for the coordination and management of all Clinical Operations Project Team members within their designated projects. Implements and manages the necessary training, tracking and quality systems within the clinical portion of the project which involves regular and proactive liaison with the Clinical Operations Managers and other functional groups, as appropriate. Also serves as the main clinical contact and support for the Customer.Responsible for functional management of multinational clinical operations members of the project team(s), including coordination, motivation and integration. In owning the clinical deliverables, is responsible for supervising all functional leads who comprise the Clinical Operations project team, to ensure that they meet project and individual targets.
  • Ppd
    Sr. Clinical Research Associate (Cra)
    Ppd Jan 2004 - Jan 2007
    Wilmington, Nc, Us
    Performs and coordinates all aspects of the clinical monitoring process in accordance with ICH GCP, FDA guidelines and global SOPs. In addition to the responsibilities below, works directly with Project Manager and Clinical Team Manager to ensure that all study timelines and clinical deliverables are met. Has an in-depth knowledge of FDA and ICH GCP requirements. Thrives in large, diverse project teams and takes on project coordination activities as a lead CRA.Conducts all applicable site visits to determine protocol and regulatory compliance, and prepares required applicable documentation. Developed collaborative relationships with investigative sites and client company personnel. Assisted Clinical Team Manager and Project Manager on assigned projects such as development of monitoring tools, study progress tracking forms, writing of the study newsletter and selection of Investigational Sites.

Jennifer Mccall Skills

Clinical Trials Ctms Gcp Infectious Diseases Clinical Development Clinical Research Cro Fda Ich Gcp Sop Ind Vaccines Clinical Monitoring Immunology Glp Therapeutic Areas Drug Development Hematology Protocol Patient Recruitment Inform Regulatory Submissions Medical Writing Pharmaceutical Industry Medical Devices Trial Management Clinical Data Management Edc Clinical Operations Regulatory Affairs Standard Operating Procedure Good Clinical Practice

Jennifer Mccall Education Details

  • Cleveland State University
    Cleveland State University
    Biology
  • Eastern Michigan University
    Eastern Michigan University
    Clinical Research Administration

Frequently Asked Questions about Jennifer Mccall

What is Jennifer Mccall's role at the current company?

Jennifer Mccall's current role is Currently on a Professional Sabbatical | Finding Passion and Purpose | Connecting with what Matters.

What is Jennifer Mccall's email address?

Jennifer Mccall's email address is je****@****eda.com

What schools did Jennifer Mccall attend?

Jennifer Mccall attended Cleveland State University, Eastern Michigan University.

What skills is Jennifer Mccall known for?

Jennifer Mccall has skills like Clinical Trials, Ctms, Gcp, Infectious Diseases, Clinical Development, Clinical Research, Cro, Fda, Ich Gcp, Sop, Ind, Vaccines.

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