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Job Details

Clinical Development Project Manager

Company: RBW Consulting
Location: Switzerland
Reference: HJ-Switz - cdpm14
Closing Date: 25 Aug 17
Type: Full Time
Salary (£): On Application
Benefits: Excellent, Full Benefits on Application

Job Summary:

Entering a pivotal Phase III study, a leading client is seeking a Clinical Development Project Manager.

Requirements:

Introduction:

The Clinical Development Project Manager will be  responsible for all aspects of the operational conduct of assigned clinical trial(s), including contribution to protocol development and other critical documents, leading the clinical trial team (vendor management), leading and organizing the conduct of the assigned trials, in compliance with GCP, according to budget and in collaboration with internal and external partners, such as internal scientist, consultants, vendors / CROs, clinical site operational staff and investigators.

Main Responsibilities:

  • Responsible for the writing of clinical documents in collaboration with stakeholders, to ensure relevant feedback is adequately integrated into protocol.
  • Contributes to the development of clinical sections of regulatory documents such as Investigators’ Brochures, briefing books, safety updates, IND/NDA submission documents, responses to Health Authorities and EC/IRB questions.
  • Accountable that Trial(s) specific documents (e.g., protocol, CRF, outsourcing specifications, data monitoring, validation plans, Project Management Plan etc.) are developed on time, to ensure completeness, high quality standard and ensure consistency between all of them.
  • Ensure timely supply of Investigational products and biological sample collection kits to sites and ensure appropriate communication channels are set up between the involved sites, vendors and operational units for secure sample shipment to respective vendors.
  • Participate to the vendor selection process and manage the outsourcing of trial related activities.
  • Responsible for proper oversight and coordination of vendors to ensure good quality of services (e.g.: Monitoring, Data management, programming, safety, statistics, medical writing) including reviewing of deliverables (e.g.: on site visit report).
  • Accountable for the preparation and maintenance of TMF.
  • Accountable for the development, management and tracking of trial budget working closely with the Head Clinical Operations.
  • Accountable for accuracy of trial information in all trial databases and internal tracking systems.
  • Accountable for all internal meetings related to the clinical trial, including setting agendas and appropriate meeting minutes / documentation of decisions taken at the respective meetings.

Qualifications and Experience:

  • A scientific degree (Bachelor’s or Master’s) or an equivalent education in life science/healthcare.
  • At least 5 years clinical experience in the pharmaceutical industry/CRO at a project management level.
  • Scientific and operational hands-on / on-the-job experience in various disciplines related to and relevant for clinical development.
  • Familiar with the drug development process, its related documentation and ICH and GCP requirements.
  • Familiar with study start-up process and requirement for pivotal trials (phase III).
  • Efficient in managing time, prioritizing tasks, planning meetings and follow-up of agreed actions.
  • Excellent organizational, attention to detail and problem solving skills are excellent.
  • Able to work independently while being a team player.
  • Able to effectively communicate with internal as well as external stakeholders and colleagues.
  • Proficient in the use of standard office software.
  • Excellent skills in English (verbal and written), knowledge of other languages is an advantage.
  • Relevant working/residency permit or Swiss/EU-Citizenship required.

Please contact me for further details.
 

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At RBW Consulting LLP, every one of our consultants has the benefit of five years experience in helping Pharmaceutical Professionals find the jobs they are looking for in the industry.

With unrivalled industry knowledge and excellent links with hiring managers in Biotechs, Pharmas and CROs throughout the UK, Europe and across the world, we would be delighted to speak with you about the role you are looking for. Call +44 (0)1293 584 300 or email howard.johnson@rbwconsulting.com for a confidential discussion about your options for progression.
 

Keywords:
Clinical Research Associate, CRA, Clinical Research, Clinical Research Scientist, International Monitoring, Project Manager, Clinical Project Manager, Clinical Project Director, Director of Clinical Operations, Clinical Study Manager, Oncology, CNS, Junior Project Manager, Lead CRA, Pharma, Biotech, International, CRO
 

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Contact Information:

Address:  Head Office
Origin Two 106 High Street, Crawley RH10 1BF
RH10 1BF
England
Tel:  01293 584 300
Fax:  01293 534 133
Website:  Visit Our Web Site

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