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Clinical Trial Manager

SolasCure Ltd.
Job LocationCambridge
EducationNot Mentioned
SalaryCompetitive salary
IndustryNot Mentioned
Functional AreaNot Mentioned
Job TypePermanent, full-time

Job Description

The companySolasCure is a UK-based biotech company, whose mission is to support healthcare professionals with wound care products that significantly improve the health and wellbeing of patients with chronic wounds. Our first product in development, AuraseTM Wound Gel, is a hydrogel containing a highly-specific enzyme, isolated and cloned from medical maggots. AuraseTM Wound Gel is meant to ease the management of chronic wound processes for hospitals, nursing homes or homecare.As an early-stage company, SolasCure is a lean environment with a flexible and friendly culture, highly reliant on teamwork, coordination, and efficient cooperation. As we are preparing our first clinical trial and future studies, we are looking for a Clinical Trial Manager (CTM) to join the team.The role (home-based)The Clinical Trial Manager will report to the Chief Development Officer. The role supports the CDO in the timely delivery of clinical research studies in compliance with regulations, GCP, company procedures, and study plans. Responsibilities include coordinating and managing activities with sites and vendors, performing monitoring oversight, implementing corrective action and preventive action plans, identifying and mitigating clinical risks, and documenting clinical activities. The job duties will be adapted on an ongoing basis to meet the requirements of the organisation and the evolving clinical development plan.Specific job duties:

  • Plans and participates in cross-functional study team(s) and/or sub-team(s) activities
  • Assists with building, managing, and maintenance of budgets, contracts and timelines for one or more clinical trial(s)
  • Prepares and reviews study specific execution plans and risk management plans
  • Facilitates alignment, coordination and effective communication within the overall clinical development team (internal and external)
  • Maintains accurate tracking and reporting of study metrics
  • Prepares study meeting agendas and maintains meeting minutes
  • Coordinates country and site feasibility for the evaluation and selection of clinical trial sites, reviews feasibility data
  • Participates and coordinates the evaluation, selection and management of clinical vendors, including performance, timelines and budget
  • Ensures appropriate escalation of issues as they arise
  • Coordinates the development and reviews of study documentation, including: clinical study protocols, consent forms, study manuals, investigator brochure and eCRFs
  • Supports clinical sites for their EC/IRB and local R&D submissions
  • Coordinates study start-up documents such as essential regulatory documents, clinical insurance, contracts, training materials, etc. in collaboration with relevant study team members
  • Participates in the EDC design development, eCRF completion guidelines review and UAT testing
  • Organizes safety review meetings with clinical investigators
  • Manages the tracking of participant enrollment, communicates the updates with relevant study stakeholders and updates the recruitment strategy accordingly
  • Reviews monitoring trip reports
  • Participates in reviews of patient listings and data trends
  • Coordinates protocol deviation meetings and manages protocol deviation reports.
  • Supports the data reconciliation and clean up for database lock
  • Supports the SolasCure QA team during audits and assists in the resolution of quality issues
  • Manages study close-out with clinical sites and vendors
  • Conducts quality reviews of the eTMF
  • Supports development of clinical research processes, templates and tools as requested
    • Requirements
  • Experience developing trial plans and extensive clinical research knowledge and a cross-functional understanding of clinical trial methodology.
  • Worked in a clinical trial management functional area for 3-5 years (CTA/in-house CRA/CPM/CSM), preferably in small/early-stage sponsor or CRO companies
  • Experience and working knowledge in pharmaceuticals required, additional experience in medical devices preferred
  • Global experience for clinical trial management, at least in both the US and the UK
  • Experience in direct study management and comprehensive vendor management, in either CRO or Sponsor role
  • Demonstrated effective problem solving, communication, presentation, multi-tasking and cross-functional/cultural skills
  • Knowledge and experience managing timelines in Microsoft Project are strongly preferred
  • Knowledge of ICH/GCP and regulatory guidelines/directives
  • Disease/therapeutic area knowledge in wound care is beneficial
    • Please submit you CV and cover letter, outlining your experience and how you would be fit for this position. Required skills
  • Biotechnology
  • Clinical Trials
  • FDA
  • Pharmaceutical
  • CE marking

    • Keyskills :
    Biotechnology Clinical Trials FDA Pharmaceutical CE marking

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