Working for Dedevan


Published on

Learn more about Dedevan, Healthcare Outsourcing company, and their open functions.

Published in: Business
  • Be the first to comment

  • Be the first to like this

No Downloads
Total views
On SlideShare
From Embeds
Number of Embeds
Embeds 0
No embeds

No notes for slide
  • 3. Tailor made site management: in kader van PIN’s= Prefered Investigator Networks
  • Working for Dedevan

    1. 1. Dedevan Clinical Outsourcing
    2. 2. <ul><li>Dedevan: Decat, Denewet & Van Berckelaer </li></ul><ul><li>founded in 2006 </li></ul><ul><li>preferred partner in healthcare outsourcing for clinical research </li></ul><ul><li>in the pharmaceutical, medical devices and biotechnology industry </li></ul><ul><li>successful in recruiting, training and providing experienced people </li></ul>Dedevan?
    3. 3. Dedevan… <ul><li>Dedevan is looking to expand its company with </li></ul><ul><li>Clinical experts </li></ul><ul><li>Looking to work as an outsourced employee </li></ul><ul><li>For our clients in the pharmaceutical, medical devices and biotechnology industry </li></ul>
    4. 4. Dedevan… <ul><li>Dedevan is looking to expand its company with </li></ul><ul><li>People with experience or ambition as </li></ul><ul><ul><li>Clinical Trial Assistant </li></ul></ul><ul><ul><li>Clinical Research Associate </li></ul></ul><ul><ul><li>Clinical Project Manager </li></ul></ul><ul><ul><li>Clinical Data Manager or Coordinator </li></ul></ul><ul><ul><li>Clinical Drug Supply </li></ul></ul><ul><ul><li>... </li></ul></ul>
    5. 5. Dedevan! <ul><li>Interested to know more or to apply? </li></ul><ul><li>Check out our website: </li></ul><ul><li>Contact us directly: </li></ul><ul><ul><li>[email_address] </li></ul></ul><ul><ul><li>02/462 00 00 </li></ul></ul><ul><li>Take a look at some of our job openings on the next pages </li></ul>
    6. 6. Clinical Trial Assistant <ul><li>Job description: </li></ul><ul><li>The Clinical Trial Assistant (CTA) is the inhouse point of contact for CRA and for the Site personnel: </li></ul><ul><li>Set up and maintain project and/or investigator files and managing Essential Documents; </li></ul><ul><li>Prepare and manage the Ethics Committee submission package in collaboration with CRA; </li></ul><ul><li>Ship/mail supplies and documents to clients and/or investigator sites; </li></ul><ul><li>Practical preparation and administrative follow up of internal and external meetings; </li></ul><ul><li>Assist in assembling materials and binders for Investigators’ meetings; </li></ul><ul><li>Keeping the project database up to date; </li></ul><ul><li>Generate and maintain study-specific tracking spreadsheets; </li></ul><ul><li>Administrative follow up of SAE's; </li></ul><ul><li>CRF Handling (data manager, cra). </li></ul><ul><li>  </li></ul><ul><li>Profile: </li></ul><ul><li>Degree in administration (A1); </li></ul><ul><li>Experience as clinical trial / project assistant in a pharmaceutical company is a strong advantage; </li></ul><ul><li>Good communication skills is in English, Dutch and French language are mandatory; </li></ul><ul><li>Stress resistant and well organised; </li></ul><ul><li>Be proactive and undertaking work meticulously; </li></ul><ul><li>Computer literate. </li></ul>
    7. 7. Clinical Research Associate <ul><li>Job description: </li></ul><ul><li>You will be responsible for the follow-up of different clinical studies: </li></ul><ul><li>Conduct pre-study visits, study initiations, monitoring and closure of the study centers; </li></ul><ul><li>Prepare and obtain all site-specific documents; </li></ul><ul><li>Obtain financial disclosure documents if required; </li></ul><ul><li>Ensure adherence of the investigator and the study personnel to the study protocol and timelines, the GCP guidelines and the SOPs; </li></ul><ul><li>Ensure good relationships and contact with all relevant parties (investigation and nursing teams, international clinical teams,…); </li></ul><ul><li>Establish procedures to monitor the results of actions, assignments, or projects. </li></ul><ul><li>  </li></ul><ul><li>Profile: </li></ul><ul><li>Medical, paramedical or scientific background or equivalent by experience; </li></ul><ul><li>Good interpersonal communication skills in English, Dutch and French; </li></ul><ul><li>Autonomous and Accurate self-starter with good organisation skills; </li></ul><ul><li>Proactive, shows initiative and positive team spirit; </li></ul><ul><li>Computer literate. </li></ul><ul><li>  </li></ul>
    8. 8. Clinical Project Manager <ul><li>Job description: </li></ul><ul><li>The Clinical Project Manager (CPM) ensures that clinical trials are effectively executed at a country/global level, from pre-study through close-out activities. Responsibilities include: </li></ul><ul><li>  Manage pre-selection and trial initiation activities; </li></ul><ul><li>Ensure trials are completed within budget, timeline, and enrolment commitments; </li></ul><ul><li>Ensures that the SOPs are followed; </li></ul><ul><li>Co-monitor sites to track progress; </li></ul><ul><li>Supervise on the proper maintenance of regulatory documentation; </li></ul><ul><li>Tracking drug and clinical trial supplies; </li></ul><ul><li>Ensure contracts are in place; </li></ul><ul><li>Perform trial close-out activities. </li></ul><ul><li>Profile: </li></ul><ul><li>Medical, paramedical or scientific study background; </li></ul><ul><li>Up to 5 years of experience in clinical monitoring and a first project management experience; </li></ul><ul><li>Good interpersonal communication skills in English, Dutch and French; </li></ul><ul><li>Autonomous and Accurate self-starter with good organization skills; </li></ul><ul><li>Proactive, shows initiative and positive team spirit.   </li></ul>
    9. 9. Clinical Data Manager <ul><li>Job description: </li></ul><ul><li>The Clinical Data Manager will create, review and implement new SOPs, essential documents and tools to build an efficient Data Management team and ensure the smooth running of the department’s activities. Responsibilities will include: </li></ul><ul><li>Prepare, coordinate and review clinical data management documents within established timelines, to a high quality standard and according to SOPs and guidelines; </li></ul><ul><li>Facilitate effective interactions and information exchange among clinical data management document authors and reviewers as appropriate; </li></ul><ul><li>Training and support of external Parties in the use of sponsor specific procedures and templates; </li></ul><ul><li>Close follow-up of timelines and Data Management activities of external Parties for Clinical Trials; </li></ul><ul><li>Assist the Lead Data Managers as required; </li></ul><ul><li>Development and Improvement of Departmental Procedures and Processes. </li></ul><ul><li>Profile: </li></ul><ul><li>(para)medical university degree or equivalent by relevant work experience; </li></ul><ul><li>At least 2 years of experience in Clinical research; </li></ul><ul><li>Knowledge of CDISC SDTM or Clinical Data Management Systems (CDMS - SAS or SQL); </li></ul><ul><li>Strong communication skills in English, knowledge of Dutch and French; </li></ul><ul><li>Excellent organization, problem solving and project management skills; </li></ul><ul><li>Accurate, conscientious and thorough. </li></ul>
    10. 10. Drug Supply (Coordinator) <ul><li>Job description: </li></ul><ul><li>The Drug Supply Coordinator defines and implements the optimized strategy of packaging and shipment of Clinical Trial Supplies. Core responsibilities will be: </li></ul><ul><li>Ensure delivery of clinical supplies within defined timelines at any time during trial duration; </li></ul><ul><li>Forecasting of drug product, comparators and of packaging workload; </li></ul><ul><li>Review protocols, analyze and evaluate feasibility and consequences of proposed designs & ensure on time development of Pharmacy manual; </li></ul><ul><li>Translation of the protocol into packaging and labelling requirements, bearing in mind all technical aspects and local regulations; </li></ul><ul><li>Create, approve & follow up the supply request in the official system; </li></ul><ul><li>Coordinate the return and destruction of supplies whenever needed; </li></ul><ul><li>Present all logistical aspects on monitor meetings, organize workshop sessions as appropriate; </li></ul><ul><li>Give training on cold chain and logistics and coach/supervise wherever needed; </li></ul><ul><li>Manage filing of all study related information. </li></ul><ul><li>Profile: </li></ul><ul><li>Master degree in Sciences or equivalent background; </li></ul><ul><li>At least 2 years experience in a clinical trials environment, monitoring experience is an asset; </li></ul><ul><li>Excellent communication skills in English, good knowledge of French and Dutch; </li></ul><ul><li>Computer literate. </li></ul>