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Contract PM

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Location
Newton, MA
Hourly
$85.00 - $150.00
Job Type
Contract
Date
Aug 23, 2016
Job ID
2372144
Primary Duties
Manages the planning, implementation, and execution of a clinical research study(ies). Manages clinical outsourcing to CROs and other vendors such as labs, IRBs, etc. May author, review and approve various study related documents and plans. Leads cross-functional teams and is responsible for the oversight and management of study timelines.     
 
Responsibilities
  • Leads the study team to design, develop and deliver the clinical study to agreed upon timelines.
  • May assist in authoring/contributing to clinical study documents and study related plans developed by Clinical CROs and vendors.
  • Leads the study team to execute the clinical study in accordance with the clinical development plan/strategy and timelines.
  • Contributes to the clinical review of Case Report Forms and corresponding completion guidelines.
  • Leads/assists in oversight of the identification and selection of investigator sites.
  • Assists and/or participates in planning and conduct of investigator’s meetings.
  • Provides input and coordinates the delivery of clinical trial supplies in collaboration with the clinical supply team.
  • Collaborates with the cross functional team on selection and management of clinical vendors.
  • Manages escalation of study related issues and communicates as appropriate with management and other R&D functions.
  • Leads in the oversight of CRO activities and other clinical vendors to ensure the quality meets company's and regulatory requirements.
  • Monitors the status of clinical data collection of assigned clinical studies.
  • May perform periodic visits to sites and/or CROs to assess progress of studies/protocol compliance.
  • Reviews clinical monitoring reports and correspondence related to monitoring visits.
  • Responsible for maintaining tracking information.
  • Reviews and approves study plans.
  • Oversees and monitors the management of the clinical study, ensuring it is conducted in accordance with the approved study plans.
  • May provide periodic status reports regarding study timelines and accruals, etc. to Management as requested.
  • May develop and/or monitor budget for clinical study (investigational sites and vendors).
  • Generate or assist in critically evaluating proposals, contracts, and change orders from CROs and other vendors.
  • Develops knowledge of therapeutic area, current medical practice and industry regulations in order to ensure best practice across all activities.
  • Supports departmental initiatives and process improvements.
  • May mentor other Clinical Operations staff (e.g. CTAs, CTM, etc).
 
Education And Experience Requirements:
  • Bachelor’s degree or nursing qualification is required. Scientific/health care field preferred, but not required.
  • Experience (2+ years) working in clinical research within a pharmaceutical company or CRO or similar organization.\ 
 
 
 
Key Skills, Abilities, and Competencies
  • Requires strong attention to detail in composing and proofing materials, establishing priorities, scheduling and meeting deadlines
  • Must be able to work in a fast paced environment with demonstrated ability to juggle multiple competing tasks and demands
  • Ability to work successfully within a cross-functional team
  • Understanding how their input and role coordinate more effective business practices for company’s Clinical Program’s business overall and committing to the culture, vision and mission of company
  • Strong knowledge of applicable computer and project management software packages.
  • Excellent written and oral communication skills.
  • Ability to interact with investigators, vendors, and internal colleagues.  
  • Knowledge of current regulatory requirements and guidelines governing clinical research.
  • Ability to complete tasks to deadlines and resolve/elevate problems in a timely manner.
 
Other Job Requirements
Available for up to 20% domestic and/or international travel