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Clinical Operations Lead/Project Manager 403 views1 application

Main responsibilities

  • Overall project management for phase 2 clinical study, including timelines and resource planning
  • Deliver phase 2 clinical study from initial planning, setup and study conduct until final reporting phase within agreed budget, timelines and with high quality (ICH-GCP and applicable regulations and guidelines)
  • Budget and contract negotiation for CRO/vendors for phase 2 study with subsequent budget, payments and contracts management
  • Act as primary contact person and supervise of selected vendors and ensure high quality study oversight according to study plans, timelines & budget
  • Input to and review of clinical study protocols, ICF, eCRF and other study related documents, from an operational perspective
  • Review and/or approve of study plans (Monitoring Plan, Project plan, Data Management Plan, Safety Plan, SAP, Mock TLFs, DTA)
  • Participate in site selection, study start up, co-monitoring and close out
  • Manage with CRO the regulatory and Ethics Committee submission review
  • Supervision of database close, analysis and study report coordination
  • Assist in set up of clinical quality system, (provide input on gaps in company/CRO SOPs and internal SOPs as needed)
  • Organize cross-functional internal Clinical Study Meetings, prepare agenda and minutes
  • Regular reporting on study conduct and budget to management
  • Ad hoc oversight of other clinical operations contractors and support in close out of ongoing Phase I study

Profile

  • PhD or MSc with (bio)medical, pharmaceutical, biochemical or biotechnological background
  • At least 5 years clinical operations and (cross-functional) project management experience at a manager level or higher, preferable also oncology study experience
  • Must have proven experience of managing and coordinating CROs/vendors
  • Structured and highly organized with a pro-active, hands-on attitude
  • Thorough understanding and experience with implementation of GCP
  • Excellent communication skills (oral as well as written)
  • Able to work in a semi-virtual environment
  • Able to work independently and make appropriate operational decisions to execute company strategy and move the clinical trial(s) forward
  • Proficient in MS office (excel, word, power point)
  • Fluent in English (oral and written)

Workload and duration (not taking into consideration planned vacation periods, which should be communicated in advance and considered for planning purposes)

  • June – August 2019: 2 days per week
  • September 2019 – September 2020: 4 days per week, likely to be extended by 12-month periods

 

Reports and is accountable to:  Chief Medical Officer

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