Job Details

Clinical Project Manager

US

Clinical Project Manager

 

Main purpose of Job

To lead and coordinate all activities specific to assigned study or program.

 

Key Responsibilities

  • Responsible for the successful execution and oversight of assigned programs ensuring the deliverables are met with quality, timelines and budget
  • Provide oversight and accountability of all third party vendors assigned to a programme. Being a point of contact, making sure programmes run in accordance with GcP and IHC
  • Lead RPF processes from proposal development through to vendor selection and contract negotiation.
  • Review, negotiate and approve any required change orders
  • Management of the overall study budget, ensuring the budget stays within forecast and the approved budget
  • Ensure adherence to pertinent regulatory requirements and to departmental policies, practices and procedures. Ensuring knowledge is kept up to date by reading SOP’s and maintaining awareness of GCP guidelines
  • Contribute to authorship of company protocol and amendment development as required. Review and approve CRFs, IRTs and other relevant specifications from a clinical perspective. Ensuring the successful support of data collection
  • Routinely review study data and progress of EDC entry; working with data management and clinical sites to resolve data discrepancies. This includes reviewing primary and secondary efficacy and safety endpoints for inconsistency, irregularities, and/or signals. Ensuring programmes meet all GCP/ICH guidelines and are inspection ready

 

Person Specification

Expereince & Knowledge

Essential
Vendor oversight experience
Fully understood and applied the principles of GCP. Creating and maintaining healthy and creative relationships with study sites and principle investigators, helping to support and influence where required
Presented high level presentations, both orally and in writing, using organizational skills to complement this
Ensured an enthusiastic and open attitude towards continuous professional development

Desirable
Proven ability to manage multiple protocols
Knowledge of the oncology therapeutic discipline

Key Behavioural Attributes

  • Analytical Thinking
  • Attention to Communication
  • Diagnostic Information Gathering
  • Managing Self Performance
  • Results Orientated
  • Teamwork
  • Thoroughness
  • Written and oral communication
  • Building collaborative relationships
  • Fostering teamwork
  • Influencing others
  • initiative
  • Interpersonal awareness
  • Conceptual thinking
  • Developing others
  • Forward thinking
  • Fostering innovation
  • Managing change
  • Providing motivational support

Education & qualification 

  • BA / BS. or higher in science related field
  • Compute proficiency in MS Word, Excel, Power Point, Outlook, MS Project, SharePoint

 


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