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Senior Project Manager

Premier Research


Location:
Raleigh, North Carolina
Date:
03/07/2017
Job Type:
Employee
Job Status:
Full Time
Categories:
  • Clinical Operations
Premier Research
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Job Details

Premier Research helps highly innovative biotech and specialty pharma companies transform life-changing ideas into reality. We have positioned ourselves right in the middle of the action, targeting unmet needs in analgesia, neuroscience, oncology, pediatrics, and rare diseases.

We’re looking for a talented and energetic Senior Project Manager to join our team in the US - this role can be office based in RTP, North Carolina or home based in the US!


You’ll be accountable for:

  • Ensuring successful management and coordination of work assigned to members of the project team, including regulatory, clinical operations, biometrics, and medical affairs/safety.
  • Adhering to the project budget and scope of work to ensure profitability.
  • Ensuring that tasks are completed in accordance with project plans and in compliance with Premier Research processes, policies, and procedures.
  • Managing resources to ensure that adequate staffing is available to meet project deliverables and milestones.

You’ll need this background to be considered:

  • Undergraduate degree in a clinical, biological, scientific, or health-related field.
  • Minimum of four years’ relevant experience in a pharmaceutical company, medical device company, or CRO, including trial management experience. At least one year of experience as a clinical manager or project lead is preferred.
  • Good therapeutic and protocol knowledge.
  • Budget/finance experience on a project level.

You’ll need demonstrated knowledge of:

  • Therapeutic and protocol disciplines.
  • ICH/GCP regulations.
  • FDA guidance documents/EU directives/ISO14155 regulations, drug/device development, and clinical monitoring procedures.
  • Basic project management principles.
  • Full-service functional areas.
  • Web-based communication tools for conferences.

Requirements

Premier Research helps highly innovative biotech and specialty pharma companies transform life-changing ideas into reality. We have positioned ourselves right in the middle of the action, targeting unmet needs in analgesia, neuroscience, oncology, pediatrics, and rare diseases.

We’re looking for a talented and energetic Senior Project Manager to join our team in the US - this role can be office based in RTP, North Carolina or home based in the US!


You’ll be accountable for:

  • Ensuring successful management and coordination of work assigned to members of the project team, including regulatory, clinical operations, biometrics, and medical affairs/safety.
  • Adhering to the project budget and scope of work to ensure profitability.
  • Ensuring that tasks are completed in accordance with project plans and in compliance with Premier Research processes, policies, and procedures.
  • Managing resources to ensure that adequate staffing is available to meet project deliverables and milestones.

You’ll need this background to be considered:

  • Undergraduate degree in a clinical, biological, scientific, or health-related field.
  • Minimum of four years’ relevant experience in a pharmaceutical company, medical device company, or CRO, including trial management experience. At least one year of experience as a clinical manager or project lead is preferred.
  • Good therapeutic and protocol knowledge.
  • Budget/finance experience on a project level.

You’ll need demonstrated knowledge of:

  • Therapeutic and protocol disciplines.
  • ICH/GCP regulations.
  • FDA guidance documents/EU directives/ISO14155 regulations, drug/device development, and clinical monitoring procedures.
  • Basic project management principles.
  • Full-service functional areas.
  • Web-based communication tools for conferences.

You also must be:

  • Available to travel.
  • Fluent in English, with strong oral and written communication skills.
  • Able to lead and motivate team members.
  • Skilled at multitasking, meeting deadlines, and working effectively in a fast-paced environment with competing priorities.
  • Skilled at handling problems decisively and objectively.

 

 
NOTES:
Telecommuting is allowed.