Global Clinical Project Manager

Randstad Life Sciences US

  • Research
  • Full time
  • 2 months ago
  • Remote
  • Remote

Job Description

12-month renewable salaried contract

**only considering candidates in the Pacific or Central time zones**

*Must have global phase 3 asthma experience*

*Must have experience working for small pharma*

Job Description:

  • Responsible for the conduct and management of one or several sponsored studies (Phase I to III)
  • Facilitates strategic decisions and provides leadership direction within the clinical operations function to optimize management of scope, financials and schedule as it impacts project execution
  • Optimizes and leverages processes, tools, metrics, resources and systems to enable effective, efficient and compliant team performance and deliverables
  • Leads and manages cross-functional project meetings
  • Authors and/or reviews study documents such as study protocols, informed consent templates, monitoring plans, DSMB/Steering committee charters, Clinical Study Reports
  • Manages processes related to DSMBs, CECs, Steering Committees
  • Leads the selection process of target countries as well as the selection and qualification of principal investigators for clinical studies
  • Oversees the organization and conduct of Kick-off meetings, Investigators‘ meetings and Coordinator meetings
  • Responsible for quality management of a clinical program (i.e. authoring, implementation, and on-going assessment of quality management plans through ongoing data reviews and review of performance metrics)
  • Responsible for clinical program drug supply forecasting
  • Responsible for adequate resource planning across multiple projects
  • In cooperation with other functional groups coaches, develops and trains junior staff on increasing responsibilities and core competencies
  • Participates in the development process of internal SOPs, if required

Qualifications Required:

  • Scientific background with a minimum of a BS degree; advanced degree preferred
  • A minimum of seven years of clinical research experience; 4-5 years as a project manager
  • In-depth knowledge in clinical study design and experience in all aspects of conducting global clinical studies and phases of research
  • Solid knowledge of ICH/GCP guidelines and regulatory requirements across regions for all clinical development phases
  • Global Phase 3 experience required, APAC preferred
  • Strong knowledge of asthma therapeutic area and acute care/hospital trial settings required
  • Demonstrates strong leadership and management skills with willingness to be heavily involved in the conduct of clinical studies
  • Strong ability to work and problem solve independently with little guidance/supervision and a proactive approach
  • Demonstrates internal and external customer expectation management and alignment
  • Strong sense of urgency and commitment to excellence in the successful achievement of defined project objectives
  • Ability to prioritize workload to meet multiple project timelines
  • Excellent planning, organization and decision-making skills
  • Ability to travel
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