KC247 - Clinical Project Manager

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Posted: 23/01/2020 15:18
Start Date: Not Available
Salary: Competitive
Location: Babraham Research Campus, Cambridge, UK
Level: Management
Deadline: 28/02/2020 23:59
Hours: 35.00
Benefits: Excellent range of benefits
Job Type: Permanent

Kymab is a clinical-stage biopharmaceutical company developing a deep pipeline of novel antibody-based therapies in a broad range of indications. The Company generates its product candidates using its proprietary, integrated platforms collectively called IntelliSelect®. Kymab’s platforms have been designed to maximize the diversity of human antibodies produced in response to immunization with antigens. Selecting from a broad diversity of fully human antibodies allows for the identification of antibodies with optimal drug-like properties.

We are looking to bring on board a Clinical Project Manager to provide support with operational delivery of one or more of Kymab’s sponsored clinical trials.

Key Responsibilities

  • To work with Senior Clinical Project Manager(s), to undertake specific activities required for the oversight of Kymab sponsored clinical trials including
    • Assisting in the selection of appropriate vendors for the conduct of clinical trial activities
    • Working with vendors to oversee specified clinical trial activities.
    • Reviewing internal or vendor generated clinical trial related documents to ensure compliance with the objectives of the trial, Kymab procedures and relevant standards.
    • Undertaking co-monitoring visits to review vendor performance
    • Ensuring essential documents allowing the reconstruction of each trial are generated, filed and maintained by or on behalf of Kymab
    • Managing trial budgets and tracking trial related payments to vendors
    • Preparing reports and or attending meetings to communicate progress and identify risks and issues arising from specific clinical trials activities to the Senior Clinical Project Manager and other Kymab clinical trial team or development team members as appropriate.
  • To maintain awareness of, and ensure compliance with, Kymab policies and procedures relating to quality standards within the Company

Job Requirements

Education & Experience

  • Degree level education or nursing or other healthcare professional equivalent
  • Experience of working with outsourced clinical trials
  • Experience of monitoring clinical trials or significant co-monitoring experience
  • ideally experience of biological therapies; experience of oncology and/or immune mediated disorders would be advantageous.

Skills & Knowledge

  • Excellent oral and written communication skills
  • Knowledge of GCP and related regulatory guidelines governing clinical trials in the UK, EU & USA

Competencies

  • Highly organised, able to prioritise work, work well under pressure and meet deadlines
  • Independent, self-starter with a proactive, problem solving approach
  • Influencer with ability to work in a flexible, collaborative style with colleagues and teams within the company and with external advisors including CROs and consultants.
  • Ability to see complex projects to completion, and to work on a broad range of tasks within a project.


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