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Clinical Study Manager - Netherlands  

Company managed [?] Still accepting applications

Posted on : 16 March 2017

Project Description


Description:
  • Our company  is a clinical-stage biopharmaceutical company that is creating and developing a pipeline of differentiated  antibody therapeutics. 
  • Our unique antibody engineering  technologies combined  with  the  complementary  expertise of our people enabled us to build a clinical-stage portfolio of novel product candidates – tailored from discovery through development to address patient needs. 
  • For  the  expansion of  our  team, our company  is  looking  for  an  experienced Clinical  Study  Manager.  
  • He/she  will  be responsible  for all  operational  aspects  of  the  assigned  clinical  studies  from  initiation  till closure  of  the  studies.
  •  The  successful candidate  will  have clinical  study operational experience  in phase I, II  and III drug development phases and is an operational expert  in the clinical study activities from  start-up, execution until closure and its  underlying  activities.  
  • The  CSM  will  be  the  “operational  clinical  study  voice”  for  the  assigned  studies,  both internally and externally, he or she is owning the timelines of a clinical study project and is accountable to keep the study on track.  
  • The successful candidate will excel in establishing good and effective internal  and external working relationships. 



Key Accountabilities/Responsibilities:  

The Clinical Study Manager will have the following key responsibilities:  
  • The CSM is responsible for all clinical operational aspects for the assigned global clinical studies from preparation until closure. The study responsibilities include: 
  •  Responsible for leading and guiding and overseeing the CROs and other (lab) vendors involved in the assigned clinical studies based upon metrics and plan 
  •  Leading CRO contracts negotiations together with the company vendor manager 
  •  Providing input into and/or developing study related materials such as Clinical Protocol, Clinical 
  • Monitoring Plans, Data Management Plans, eCRF and completion guidelines, patient information and informed consent, site instructions for specimen collections, study drug order forms 
  •  Overseeing and tracking patient recruitment and pro-actively identifies ways to prevent recruitment delays 
  •  Ensuring that study Trial Master File is maintained and up to date 
  •  Ensuring clinical studies are conducted in compliance with ICH-GCP and other applicable legislation  
  •  Reviewing monitoring reports, protocol deviations and data listings for studies to ensure reliable quality data are delivered  
  •  Facilitating timely availability of investigational product supply on site and ensuring that clinical site accountability records on site are maintained 
  •  Ensuring timely collection of documentation for adverse event safety monitoring and collaborating in submission of Med-watch reports to FDA, EMEA and other applicable regulatory authorities
  •  Ensuring timely SAE reporting to the responsible IRB and Competent Authority agencies according to the applicable (local) legislation. 
  •  Establishing and maintaining good relation with clinical site and study personnel 
  •  Co-monitoring CROs personnel upon predefined plan 
  •  Pro-actively identifying and solving issues in the assigned clinical studies and timely escalating them to 
  •  Leading and guiding the internal clinical study team and chairs study team meetings 
  •  Communicating in a transparent, clear way and motivating team members to work towards achieving clinical study goals 
  •  Preparing of study timelines and budget and delivering studies within timelines, scope and budget, aligned with the clinical development plan and quality in line with the company  quality standards 
  •  Responsible and contact person during inspections/audits for the assigned studies 


The CSM will also participate in activities other than study-related which include but are not limited to: 
  • Providing input to the clinical development strategy/plan 
  •  Co-writing/maintaining SOPs within the Clinical Operations department 



Desired Skills and Experience: 
  •  Knowledge of ICH-GCP and other applicable legislation to successfully execute the clinical study 
  • Experience with tools and systems for managing clinical studies (MS project, study progress and metric systems, eCRF databases) 



Offer: 
  •  A competitive salary package with extensive benefits 
  •  A work environment in a human-sized, dynamic, rapidly growing biotech company