Company: We are Immutep, an emerging international biotechnology company developing immunotherapeutic products for cancer and autoimmune diseases. With operations based in Australia, USA, Germany and France, Immutep is dedicated to bringing innovative treatment options to market for patients. The company is publicly traded on the ASX and NASDAQ.
Location: Berlin, Germany; full-time
Summary: As a result of continuous progress in our projects we want to expand our team and therefore seek a (Senior) Clinical Trial Manager. You will be responsible for one of our international clinical trials. This implies the preparation and processing of national and international projects under consideration of local laws, international guidelines (ICH GCP) and applicable SOPs. You will be responsible for the timely performance of all services, control of third party providers, as well as problem management by interacting with all internal departments and external vendors involved.
Job description:
Trial management of national and international clinical studies in accordance with GCP, applicable local laws, international guidelines and SOPs
Provide regular status updates to the director of clinical development (and the senior management)
Oversee clinical trials in regards but not limited to status, budget, safety and quality
Prepare and contribute to clinical core documents (e.g. Investigator Brochure, Trial protocol, trial amendments, Patient information sheet and consent form, Case report forms and others)
Set up and maintain the clinical trial database/tracker
Ensure the setup and maintenance of the TMF/ISF (TMF is handled by CRO)
Ensure timely submission of all required trial applications to Competent Authorities and Ethic Committees/Independent Review Boards
Organize and conduct investigator meetings
Support the process of country and ensures site selection
Vendor and CRO management; serve as main contact for outsourced activities, and manage CRO, if applicable
Conduct Co-Monitoring visits, as applicable
Support preparation, conduct and follow-up of GCP audits and GCP inspections
Support the director clinical development on program level documents
Skills/Experiences/Qualifications:
Natural/ life sciences or medical background (university degree or experience in a medical profession such as Nurse or Medical Technical Assistant or Pharmaceutical Technical Assistant)
Profound knowledge and experience in relevant legislation and international guidelines (ICH-GCP) for the performance of clinical research projects
Minimum 3 years (5 years is a minimum for the senior position) of experience in trial management, regulatory submissions, monitoring of clinical trials with practice in project planning and structuring on CRO or sponsor side
Refined colloquial and correspondence skills in German (written and spoken)
Very good English (written and spoken)
Very good knowledge of standard software (Word, Excel, Outlook, Power Point, CTMS/EDC systems)
Experience in oncology, immune oncology is a plus
Sound understanding of clinical evaluations and regulatory affairs processes
General understanding of R&D processes
Job expectations:
Multifunctional interesting tasks in the emerging field of immune therapeutics
Be part of the development of a “first in class” drug
Highly motivated and energetic international team
Permanent contract, office based
Competitive compensation
If you are interested in this challenging career opportunity, please send your CV, certificate of employments, salary expectations, application letter and your earliest possible entry date until January 21st, 2018 to the following e-mail address (confidentiality is of course guaranteed): [email protected]
In case of questions you are welcome to contact us: +49 341 23100372
IMM Price at posting:
2.4¢ Sentiment: Buy Disclosure: Held
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