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enquiries@nicholashoward.co.uk

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We have a large number of permanent, contract and fixed term jobs across the UK and Europe within a wide range of fields of work

Investigator Initiated Research Manager – 12 month contract

Nicholas Howard Ltd are delighted to be recruiting for an Investigator Initiated Research Manager for a Global Pharmaceutical company to work remotely in the UK

Primary Duties

  • Oversee Investigator Initiated Research (IIR) programs within assigned Therapeutic Area(s)
  • Manage the IIR proposal review process for assigned Therapeutic Area(s)
  • Support the initiation and conduct of IIR(s) through internal and external stakeholder coordination.
  • Monitor and report progress and outcomes of IIRs to internal stakeholders

Responsibilities

  • Manage all aspects of the IIR review and approval process from proposal review all the way through study completion:
  • Coordinate timely review of IIR proposals by the global grant review committee and additional internal stakeholders.
  • Facilitate global IIR review committee meetings
  • Ensure appropriate and efficient follow-up of review committee action items, decisions, and/or requests for additional information regarding IIR proposals
  • Work with legal, regulatory and compliance colleagues to facilitate the efficient creation and execution of IIR study contracts and amendments
  • Secure and manage IIR drug supplies and vendors, forecast study drug supply requirements, and initiate requests for assigned programs
  • Interact directly with external Principal Investigators, research sites, and/or CROs to ensure compliance with policy, global and local healthcare laws
  • Tracks study progress against proposed timelines and provides regular updates to key internal stakeholders (e.g., Evidence Generation Lead) on IIR study progress
  • Collect and evaluate IIR study progress reports for adherence to compliance guidelines
  • Secure study results, required documentation, and publications from completed studies and coordinate with appropriate functional groups for review and implement study closure procedures
  • Oversee Investigator initiated research (IIR) programs within assigned Therapeutic Area(s):
  • Manage Program budget, spend and forecasting
  • Develop annual IIR plan (areas of interests) in collaboration with key internal stakeholders
  • Engage and communicate clearly and concisely with external and internal stakeholders, globally, regarding all aspects of the IIR program.
  • Work with appropriate study team members to ensure compliance with processes, systems, and regulations, external healthcare laws
  • Stay informed of applicable governmental compliance laws and industry standards for IIRs
  • Monitor and report progress and outcomes of IIRs to internal stakeholders:
  • Provide regular updates to Evidence Generation Lead and other internal stakeholders regarding IIR-related activities
  • Communicate IIR study progress to key stakeholders to facilitate ongoing functional and regional planning and inform dependencies
  • Follow up with principal investigator to determine results of research and planned publications
  • Report outcomes of IIR to internal stakeholders

Education and Experience Requirements

  • A relevant scientific bachelor’s degree- PhD is preferred
  • At least 2- 4 years of experience in the biopharmaceutical industry, preferably within a matrix structure and international environment is required
  • Experience with program- or project management required
  • Experience in clinical research setting(s) (e.g., clinical trial management, data management, etc.) and/or medical affairs preferred
  • Familiarity with clinical, regulatory, and legal guidelines regarding clinical study design and best practices (US and globally) is strongly preferred

Key Skills, Abilities, and Competencies

  • Strong relationship management skills, especially with Principal Investigators
  • Strong attention to detail
  • Focus on accountability and ownership
  • Excellent communication, presentation, and written skills
  • Unquestionable ethics
  • Experience in budget forecasting, metrics generation and program operations data analysis preferred.
  • Experience with Request- or Study Management systems
  • Understanding of the clinical study design and execution, statistical methods and clinical trial data reporting requirements