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Job Details

Clinical Project Manager - Poland

Company: Umbilical Life
Location: Poland
Reference: DAX/CPM/Poland
Closing Date: 03 Dec 17
Type: Permanent
Salary (£): Competitive
Benefits:

Job Summary:

Dax Kruczkowska of Umbilical Life is recruiting a Clinical Project Manager for pharmaceutical business. You can expect a challenging and rewarding job opportunity in a fast moving, flexible environment and a highly motivated team.

Requirements:

Responsibilities

  • Preparation of Request for Proposals and selection of CROs to conduct outsource clinical activities 
  • Management of third party suppliers where necessary project managing the interface between different third-party suppliers (e.g. Phase 1 Unit; CRO for statistical support and analysis). 
  • Review and/or preparation of Clinical Study Protocols, Investigator Brochures, Clinical Study Reports. 
  • Review of study documents and monitoring reports, study plans (DMP, SAP, project plan etc.). 
  • Attendance at Investigator meetings, Site Initiation Visits, co-monitoring with CRAs. 
  • Set up and maintenance of Study Shadow File. 
  • Management of clinical study documents on Document Management System. 
  • Distribution of key study documents. 
  • Preparation/review of regulatory document packages for IMP release. 
  • Distribute and track internal and external study documentation as requested (e.g. confidentiality agreements, contracts, protocols, IBs etc).
  • Develop and maintain tracking tools to assist with “oversight” of study (e.g. contact lists, document management plans etc.). QC of study documents.
  • Prepare clinical trial documentation for archiving (in-house files/combine CRO files). 

Qualifications:

  • Degree level preferred but not essential. 
  • At least 2 years’ experience of clinical research preferably as a CPM or PM assistant. 
  • Good organisational skills, good attention to detail. 
  • Self-starter, happy to work on their own and in a team. 
  • Strong inter-personal skills with the ability to influence both CROs and study site staff in a respectful manner while achieving successful outcomes. 
  • A willingness to get stuck in and make things happen, a “can do” attitude. 
  • Ability to remain positive and try to keep studies on track even when things aren’t running smoothly or to plan. 
  • Ability to multi-task and be flexible in approach to work. 
  • Willing to take on all aspects of the role, including filing and administrative tasks. 
  • The flexibility to adapt to changing circumstances and manage activities to meet the needs of the business while maintaining a focus on quality. 

For a confidential discussion please contact Dax at Umbilical on +44 (0) 116 461 0070 or email dax@umbilical-life.com

Apply for this job: Clinical Project Manager - Poland

Contact Information:

Address:  Head Office
Premier House 9 Rutland Street Leicester
LE1 1RE
England
Tel:  011 6 461 0070
Website:  Visit Our Web Site

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