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For more information speak to Danielle Boniface on 01707 817313

To apply by email danielle.boniface.77162.10471@justpharma.aplitrak.com

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Clinical Trial ManagerRef: BBBH4437

Salary:Up to £0.00 per annum

Added:25 Oct 2018

Region: Germany

Category: Clinical Development

Just Pharma are currently working on behalf of a German biotechnology company who are searching for Clinical Trial Manager.

YOUR RESPONSIBILITIES:

  • Maintain a strong knowledge of the protocol to be able to answer operational questions from CRO Site Management Team (i.e. Clinical Trial Managers/Lead Clinical Research Associates (CTMs/Lead CRAs) and Clinical Research Associates (CRAs)) and investigator sites
  • Recognize potential challenge within the protocol and operational aspects of the trial and escalate to Clinical Trial Leader (CTL) for development of appropriate actions if required
  • Contribute to the development of trial execution plan and support trial feasibility
  • Train CRO Site Management Team on the protocol and key trial elements together with CTL for performing site selection
  • Recommend list of sites for trial participation to Clinical Trial Team (CTT) and monitor the progress of site selection and initiation
  • Develop and implement site management oversight plan
  • Monitor the progress of site selection and site initiation visits
  • Work with CRO Site Management Team and ensure that all essential documents are in place for approval of site initiation and release of Investigational Medicinal Products (IMP) to the sites
  • Provide training as needed to the CRO Site Management Team and any other activities that support site readiness to recruit
  • Ensure monitoring visits are performed by CRO CRA according to the monitoring plan
  • Review site issues and relevant monitoring visit reports to identify quality/compliance issues that require escalation to CTL and/or require follow-up with the CRO Site Management Team for resolution with the sites
  • Perform co-monitoring visits with the CRO CRA as required
  • Perform periodic review of protocol deviations and issues to identify any trends for communicating and taking appropriate actions with CTL and/or Quality Assurance
  • Provide governance on country and site-specific TMFs maintained by the CRO Site Management Team
  • Communicate with CRO Site Management Team on a regular basis to assure proper adherence to protocol, timelines and other trial related topics
  • Serve as main contact to CRO Site Management Team for any potentially significant quality/compliance issues and escalates to CTT as required
  • Attend and participate in CTT meetings
  • Review and communicate with CRO Site Management Team to ensure timely CRF data entry and resolution of data issues by the sites
  • Ensure that all trial close-out activities are performed, in close cooperation with CRO Site Management Team and CTL
  • Participate in internal audits and HA inspections as required
  • Lead or actively contribute to process improvement or act as Subject Matter Expert for training or SOPs
  • Coach new CTMs during their onboarding as assigned

YOUR REQUIREMENTS:

  • Ideally five years in pharmaceutical industry with at least three years strong experience in clinical research in a field monitor role or a role overseeing clinical trials
  • Thorough knowledge of Good Clinical Practice, regulatory processes, and clinical trial process
  • Experience with health authority inspections (FDA and/or EMA) preferred
  • Strong Interpersonal skills and communication Skills
  • Strong Project Management and leadership skills
  • Working experience in a global team, team player
  • Results oriented and ability to work under pressure
  • Ability to work in a matrix environment
  • Display innovative ideas and solutions
  • Highly proficient in negotiation skills and effective in influencing others
  • Fluent English (oral and written)
  • Willingness to travel

WE OFFER:

  • Creative working in X-functional teams
  • Open and appreciative corporate culture
  • Multicultural environment
  • Working in an attractive, high-quality equipped building with restaurant
  • Free sports and language courses

Please get in touch with Danielle at +441707817313 or email

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