Tel: 01753 868 960
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  • Salary 120’000-180’000CHF per annum
  • Business Type a leading biopharmaceutical company
  • Job Type Permanent, full-time, office-based
  • Location Basel area of Switzerland
  • Background Our client is a leading biopharmaceutical company focused on the discovery, development and commercialisation of innovative drugs for diseases with significant unmet medical needs. A new vacancy has arisen for a (Senior) Clinical Project Scientist to work in a team of 10 other clinical research professionals on early clinical development projects within the CNS area at their Swiss HQ on the borders of France & Germany.
  • Primary Duties You will contribute to study design, manage & monitor a clinical trial from set up to completion independently, perform literature reviews and contribute to project specific documents including Clinical Development Plan, Investigator Brochure, Annual Reports, Risk Management Plan, Publication Plan. You will also maintain contact and organise meetings with Key Opinion Leaders, answer questions from Health Authorities, and present and defend the project to external experts. As a Senior Clinical Project Scientist you will also be involved with regulatory submissions, deputise for the Clinical Program Head and coach junior team members.
  • Qualifications PhD, MD, MSc or equivalent life science degree with 5y+ clinical research experience (particularly in the CNS arena) in the pharma/CRO industry for a thorough understanding of clinical drug development (from preclinical to commercial), a sound knowledge of regulatory requirements/ICH-GCP guidelines, and a proven record of writing protocols (PhI/II), managing studies & contributing to project related regulatory documents. You will be familiar with the area of CNS medicine (anxiety, psychatry) and understand the competitive landscape to identify its impact on the project. With an ability to handle and oversee multiple tasks simultaneously, you are able to adapt quickly to change and capable of prioritising workload in a high-pace environment. Good communication, interpersonal & persuasive skills are required for working in a matrix organisation. Fluency in written/spoken English is an absolute requirement and knowledge of German is advantageous. To apply for this position, you should have the legal right to work and live in the EU and to participate in the international travel commitment of the role. Travel commitments are <5%.
  • Job Number 18/014
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  • Salary c100,000CHF plus car allowance + travel expenses
  • Business Type Top-five CRO
  • Job Type Permanent, full-time, home-based (3d/w)
  • Location Greater Zurich region, Switzerland
  • Background A top five CRO that has worked on 100+ marketed drugs across many varied therapeutic areas and conducted the pivotal or supportive trials resulting in their FDA and/or international regulatory approval. A vacancy exists for a home based CRA to work 2 days/week at their client’s premises in the greater Zurich region. Operating as a key member of a global study team, you will play a fundamental role in the drug development process.
  • Primary Duties You will be ultimately responsible for the successful management of investigator sites throughout the site lifecycle, whilst working in accordance with ICH-GCP guidelines, the study protocol, applicable local & international regulatory requirements and internal SOPs. With full ownership of investigator sites for assigned studies, your involvement begins at site feasibility stage, with responsibility for the successful management of the site through to close-out. In addition to planning and conducting various site visits (feasibility, site selection, interim, close-out) in accordance with the clinical monitoring plan, you will foster effective relationships with investigator site staff to ensure that key clinical metrics are met. This involves establishing innovative ways of increasing site & patient recruitment, implementing corrective action plans when issues occur, and designing & delivering training to site staff. Other duties will include preparing for & attending investigator meetings, coordinating the timely shipment and the subsequent proper storage & accountability of clinical supplies, and following-up drug safety issues that have occurred at site. You will also ensure integrity of clinical data through an ability to maintain site tracking records & work to relevant guidelines.
  • Qualifications Demonstrable experience of investigator site management, including conducting monitoring visits, gained over 2y of working in either pharma or CRO environments. Prior working knowledge of ICH-GCP guidelines and local & international regulatory requirements is essential. Fluency in English is an absolute requirement, as well as good working knowledge of German and Italian in order to communicate effectively with others.
  • Job Number 18/008
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Last modified on Tuesday, 05 April 2016 07:25
  • Salary 100,000CHF plus car allowance & travel expenses
  • Business Type Top-five CRO
  • Job Type Permanent, full-time, home-based (3d/w)
  • Location Greater Zurich region, Switzerland
  • Background A top five CRO that has worked on 100+ marketed drugs across many varied therapeutic areas and conducted the pivotal or supportive trials resulting in their FDA and/or international regulatory approval. A vacancy exists for a home based CRA to work 2 days/week at their client’s premises in the greater Zurich region. Operating as a key member of a global study team, you will play a fundamental role in the drug development process.
  • Primary Duties You will be ultimately responsible for the successful management of investigator sites throughout the site lifecycle, whilst working in accordance with ICH-GCP guidelines, the study protocol, applicable local & international regulatory requirements and internal SOPs. With full ownership of investigator sites for assigned studies, your involvement begins at site feasibility stage, with responsibility for the successful management of the site through to close-out. In addition to planning and conducting various site visits (feasibility, site selection, interim, close-out) in accordance with the clinical monitoring plan, you will foster effective relationships with investigator site staff to ensure that key clinical metrics are met. This involves establishing innovative ways of increasing site & patient recruitment, implementing corrective action plans when issues occur, and designing & delivering training to site staff. Other duties will include preparing for & attending investigator meetings, coordinating the timely shipment and the subsequent proper storage & accountability of clinical supplies, and following-up drug safety issues that have occurred at site. You will also ensure integrity of clinical data through an ability to maintain site tracking records & work to relevant guidelines.
  • Qualifications Demonstrable experience of investigator site management, including conducting monitoring visits, gained over 2y of working in either pharma or CRO environments. Prior working knowledge of ICH-GCP guidelines and local & international regulatory requirements is essential. Fluency in English is an absolute requirement, as well as a good working knowledge of German and French in order to communicate effectively with others.
  • Job Number 18/007
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Last modified on Tuesday, 05 April 2016 07:25

Blue Heron Ltd.

Contact Lynne Dowse or Peter King Tel 01753 868 960 Fax 01753 859 172 Email This email address is being protected from spambots. You need JavaScript enabled to view it. This email address is being protected from spambots. You need JavaScript enabled to view it. Address Blue Heron Ltd, Heronwood, St Leonard's Hill, Windsor, Berkshire SL4 4AT