Posted to MedZilla on 9/21/2017


ProClinical

Belgium, Senior R&D Trial Physician CR_MR_13280-MZ


 
 

This Senior R&D Trial Physician job is with one of the most renowned global pharmaceutical, medical device and consumer health organisations located in Beerse, Belgium. The organisation is a top 10 pharma company and employs over 100,000 professionals worldwide.

Job Role:

  • Report regularly and work closely with Global Medical Leader
  • Interact with clinicians/experts (e.g. Advisory boards) as necessary
  • Act as a support to and resource for Medical Affairs.
  • Assist in the creation of regulatory/submission documents (e.g. clinical summaries, clinical overviews, ASR, IND update)
  • Assist in creation of Investigator Brochure.
  • Assist in writing/review of abstracts/manuscripts.
  • Contribute to the development and improvement of departmental procedures and processes and templates in the scope of the companys effort towards continuous quality improvement.
  • Participation and cooperation in Clinical Team and in other Cross-functional teams, ad hoc.

Pre-trial activities include:

  • Review the Trial specific Master Informed Consent Form within the specified timelines.
  • Review the Statistical Analysis plan (SAP) within the specified timelines.
  • Review the Data Safety Monitoring Board (DSMB) protocol.
  • Review and approve protocol specific PV criteria list
  • Develop & agree on the Safety Management Plan (frequency, format and content of reports provided)
  • Input in SOW for central lab, central ECG and other vendors as applicable

During trial activities include:

  • Answer trial related medical questions and interact with investigators/sites, CROs, etc.
  • Review medical aspects of screening and ascertain suitability of subjects as needed
  • Review of Data and Safety Monitoring Board (DSMB) reports as applicable.
  • Perform medical review and safety analysis of clinical trial subjects; including periodic completion of the Safety Management Plan for individual trials.
  • Assist in the determination whether new safety information requires an Amendment to the CTP and/or ICF
  • Review and approval of AE coding and concomitant medication lists.
  • Review AEs of Special Interest

Post-trial activities (or activities related to an upcoming analysis)

  • Review and approval of AE coding and concomitant medication lists.
  • Review PV listings
  • Assist in preparation of the safety part of Top Line Results presentation
  • Review narratives
  • Assist in creation and review of Clinical Research Report and approve if applicable
  • Assist in ADR review and adjudication
  • Assist in labeling process as applicable
  • Contribute to presentation of trial results as needed

Role Requirements:

  • Employee must follow the schedule for mandatory trainings for this position, within the specified time frame; including, but not limited to International Conference on Harmonization (ICH)/Good Clinical Practice (GCP) guidelines and regulations, as well as other Standard Operating Procedures (SOPs)
  • It is expected that the employee will keep up-to-date with general medical topics and topics relevant to the therapeutic area
  • University degree - medical
  • Preferably experience in drug development (e.g. Project Management, Pharmacovigilance, Medical Affairs, Pharmacokinetics), and/or
  • Preferably experience in clinical development (e.g. medical dept. or operations);
  • Experience in functioning in team structure

To Apply:
Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.
In case you have difficulty in applying or if you have any questions, please call [Maartje Ramakers on +44 207 4400 632 or upload your CV on our website - www.proclinical.com.
A full job description is available on request.
ProClinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.


Please visit our website at www.proclinical.com

 
 


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