(Senior) Manager, Site Management, SEA

Permanent Position Singapore
17 Jan 2017
Expires on 31 Mar 2017

Company Description

Japanese CRO MNC

Posted by

Ewen Poh (R1550486 16S8408)

Tel

+65 6730 6188/ +65 9738 8821

Email

Job Description

  • Line Management: Responsible for the supervision and administrative oversight of Regional CRAs
  • Keeps project leadership apprised of team issues, seeking guidance
  • Develops clinical guidelines, including clinical monitoring plans
  • Regulatory Documentation
  • Monitoring and Oversight: Reviews the study scope of work, budget and protocol content
  • Business Development: Prepares and presents materials for bid defense meetings

Requirements

  • BS or Master’s Degree in nursing, life science, or related field (or equivalent experience)
  • Minimum of 6 years of clinical research experience, at least 3 of which are as a Project Manager for clinical studies at a CRO and/or pharmaceutical/biotech organization
  • Previous experience negotiating vendor/site contracts and managing the budgets
  • Thorough understanding of FDA, ICH and GCP guidelines
  • Experience with Phase I – IV clinical trials
  • Proven track record showing clear proficiency in clinical project management skills
  • Proven complex problem solving skills
  • Broad understanding of clinical operations related to clinical development functions
  • Detailed understanding of all aspects of clinical protocol design and implementation & overall drug development
  • Ability to effectively interface with medical personnel at clinical site(s)
  • Ability to lead multi-disciplinary, cross-functional teams both internally & externally
  • Ability to write and edit technical documents, such as protocols, protocol amendments, informed consent, and other trial-related documents
  • Detail and team oriented with excellent cross-functional team leadership and participation skills
  • Excellent interpersonal, verbal and written communication skills are essential in this collaborative work environment
  • Proficiency with computer programs including Microsoft Office suite and Microsoft Project
  • Ability and willingness to travel 25% of the time

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