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Vaccine Management Assistant (VMA) for a phase I vaccine clinical trial

The European Vaccine Initiative (EVI) is a non-profit organisation based in Heidelberg, Germany.  EVI is dedicated to accelerating the development of vaccines for diseases of poverty.

EVI has an exciting career opportunity for junior and motivated individual to join the organisation in an eighteen month full time position as Vaccine Management Assistant (VMA) for a phase I vaccine clinical trial.  The role of the VMA will be to oversee the progress of the clinical trial, and to ensure that it is conducted, recorded, and reported in accordance with the protocol, the Standard Operating Procedures (SOPs), the Good Clinical Practice (GCP), and the applicable regulatory requirement(s).  The VMA will also be charged with ensuring the quality and integrity of data, and study completion on time and within budget.

Responsibilities:
  • To assist the Vaccine Development Leader (VDL) in the coordination and conduct of the phase Ib clinical trial of the SEmalvac project
  • To be the main line of communication between the investigators, clinical monitor, EVI and the sponsor
  • To ensure absolute adherence to Good Clinical Practice in accordance with ICH-GCP standards, Declaration of Helsinki, Regulatory Requirements and study procedures
  • To develop/update SOPs in accordance with ICH-GCP standards, Declaration of Helsinki, Regulatory Requirements
  • To develop, review and edit clinical trial related documentation including but not limited to: CRF, Informed Consent Forms, study specific handbooks, guidelines and checklists
  • To assist with study protocol design, development and / or review if required
  • To complete and compile all necessary research, documentation and information to gain appropriate regulatory and ethical committee approval where required
  • To ensure adequacy of vaccine shipment and vaccine accountability
  • To liaise with the clinical monitor, principal investigator, coordinator, project leader and sponsor representatives as required
  • To organise / attend investigator meetings as required
  • To provide support to the VDL with ad-hoc tasks as required
  • To identify and discuss potential difficulties and barriers associated with achieving the set tasks
  • To plan and organise monthly meetings and TC’s with the principal investigator of the clinical trial site
  • To highlight and present any difficult issues those need the attention of the project Steering Committee.
  • To assist in the technical/administrative reporting of the progress of the work plan to the VDL

Qualification/Essential Skills/Competencies:
  • Bachelor’s degree or equivalent qualification within Medicine, Biological Science, Pharmacology, Nursing, Clinical Research or a relevant life sciences discipline
  • Clear understanding of the vaccine/drug development process
  • One to three year experience in clinical development at the level of Clinical Research Assistant/Associate.
  • Proven track record of training and adherence to ICH-GCP and applicable local regulatory requirements during the conduct of clinical trials
  • Ability to contribute to the development of clinical trial related documents and materials
  • Good communication skills including the ability to present complex information to both clinical and non-clinical disciplines
  • Excellent presentation skills including the ability to meet exacting standards and a keen attention to detail
  • Willingness and ability to travel
  • A high standard of written and spoken English and French is mandatory.
  • Knowledge of Microsoft Project, Microsoft Office and Microsoft Access is mandatory

Desired Skills/Competencies:
  • Experience across a wide range of clinical indications / therapeutic areas
  • Ability and experience to work with an electronic case report form (eCRF)
  • Planning and organising: Proven ability to be able to plan and manage clinical trials.  Ability to work within deadlines.
  • Respect of diversity: Good interpersonal skills; Demonstrated ability to work in multicultural and multi-ethnic environment and to maintain effective working relations with people of different national and cultural backgrounds.

Conditions of Appointment:
  • Contract period will be 18 months from 1st April 2015.  A probationary period of three months will apply.
  • The position is full time
  • Attractive salary conditions will be offered.
  • Successful applicants will be based either in Heidelberg or Paris.
  • International travels are to be expected.

Female candidates are strongly encouraged to apply for this position.  If you feel that you possess the relevant skills and working background please send a Curriculum Vitae and covering letter explaining:
  • Your suitability for the position.
  • Your salary range expectations.

Applications providing all of the requested information should be received no later than 17:00 (CET) on 27th February 2015, and sent by email to:

Nathalie Imbault
European Vaccine Initiative
Quality Assurance Director
e-mail: contact.usateuvaccine.eu

Please see: http://www.euvaccine.eu/about-us/vacancies

Contact detail


How to apply:
Applications providing all of the requested information should be received no later than 17:00 (CET) on 27th February 2015, and sent by email to:

Nathalie Imbault
European Vaccine Initiative
Quality Assurance Director
e-mail: contact.usateuvaccine.eu
 
Send application to
Nathalie Imbault
European Vaccine Initiative
Quality Assurance Director
e-mail: contact.usateuvaccine.eu

Job profile


Working hours
Full-Time
Contract duration
Temporary
Type of job
Specialist
Work experience
job experience is not required
Region
France, Germany (Baden-Württemberg)
Working place
69120 Heidelberg
Area of expertise
Healthcare & Public Health, Biology & Life Sciences
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