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Senior Clinical Research Manager (m/f)

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Rigontec GmbH, a privately held biopharmaceutical company developing RNA-based immunotherapeutics for the treatment of cancer and viral diseases,  is developing synthetic ligands of a novel receptor of the innate immune system, Retinoic Acid-Inducible Gene I (RIG-I), which recognizes viral RNA. RNA motifs that activate RIG-I promote the destruction of diseased cells and the induction of a lasting immune memory, thereby treating and preventing recurrence of disease.

We offer the position of

Senior Clinical Research Manager (m/f)

in our subsidiary in Martinsried near Munich, starting 1st of September 2015.
Early Phase Studies
Job Description
  • Assume overall responsibility for the study planning, implementation, conduct and analysis (contracted to a Contract Research Organisation), especially in early phase studies
  • Ensure that all aspects of GCP are complied with at all times
  • Ensure that timelines are adhered to by the CRO
  • Ensure quality of the study conduct by the CRO
  • Ensure the smooth running of the clinical research department by developing systems to track projects including all study, investigator, and ethical review board information, patient recruitment activity, and financial management
  • Assume responsibility for the financial management of the clinical trial programme including budget planning, resource allocation, and preparation of quarterly reports
  • Accountability for all aspects of vendor management for assigned studies, responsible to drive them to complete their activities in accordance with any contracted terms
  • Accountability for all project timelines and deliverables. Evaluate and communicate the probability and impact of risks, develop quality and risk management plans for performance and ensure this is integrated into the overall monitoring plan for the project management, deliverable in accordance with project plan
  • Oversight of the feasibility process, development of the feasibility questionnaire
  •  Oversight of the label approval process
  • Prepare and work with meeting planning group to plan and execute the coordination of the investigator meetings
  • Responsibility for ensuring that all data pertaining to study status is compiled and reported monthly as appropriate
  • PHD in health science required preferentially in oncology, immunology
  • Clinical trial experience within pharmaceutical, biotechnology or CRO i.e., managing the logistics of clinical trial conducts and developing/executing project plans for clinical development programs
  • Analytical, negotiation, meeting management, cross-functional team, and leadership skills required as demonstrated from representation at a management level
  • Demonstrated computer skills using common Microsoft systems
  • Demonstrated core understanding of medical terminology and clinical trial activities in relation to execution of a clinical development plan
  • Experience in international trial management especially early phase studies
  • Knowledge of GCP relating to clinical trial management
If you are interested in this challenging and rewarding position, please don’t hesitate to contact us.

We are looking forward to receiving your comprehensive application via e-mail.




Art des Bewerbungszugangs
We are looking forward to receiving your comprehensive application via e-mail.

Kontakt für Bewerbungen
Rigontec GmbH
Frau Angela kayser
Life & Brain Center
Sigmund-Freud-Str. 25
53127 Bonn

Details der Stellenanzeige

Bereichs- & Abteilungsleitung
Berufserfahrung vorausgesetzt
Deutschland (Bayern)
82152 Planegg - Martinsried
Biologie & Life Sciences, Humanmedizin