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Clinical Project Manager

Solis Mammography/ Washington Radiology
Addison, TX
  • Expired: May 17, 2022. Applications are no longer accepted.

Whether at our Solis Support Center or one of our many patient care centers across the nation, Solis team members share a common goal: to make a difference in the lives of everyone we serve. Patients and fellow team members are our priority, and we strive to serve them with a caring and compassionate attitude, warm and welcoming service and an easy and efficient experience throughout.

For more than 30 years, our patient-first attitude has been our objective - with a work environment designed around patient comfort, making services accessible and convenient, delivered reliably and consistently every time. We embrace this mantra and our team members are carefully selected to fit within the Solis culture.

The Clinical Project Manager (CPM) is responsible for the management of all aspects of research activities for assigned project(s). The CPM, in concert with the Senior Director of Clinical Quality and Patient Safety, is accountable for achieving successful delivery of Solis clinical team activities at the project level by meeting company and regulatory requirements according to time, quality/scope and budget constraints.

RESULTS MEASURED BY THE FOLLOWING RESPONSIBILITIES:
• Proactively manage project level operational aspects of the clinical research team including management of trial timeline, budget, resources and vendors.
• Provide efficient updates on trial progress to the Senior Director of Clinical Quality and Patient Safety, with respect to vendor selection, project plans, trial budget and timeline management, quality standards and risk mitigation.
• Lead sponsor study startup process, including but not limited to conduct of the Trial Kick-off meeting, the set-up of a trial master file (TMF) or Regulatory Binders, site selection and finalization of site and vendor Clinical Trial Agreements and budgets.
• Ensure effective project plans are in place and operational for each trial and work proactively with the clinical research team and Center Directors to set priorities in accordance with applicable project plans, company standard operational procedures (SOPs), ICH/GCP guidelines and regulatory requirements.
• Ensure potential study risks are escalated to the attention of the PI, Center Director and/or Senior Director of Clinical Quality and Patient Safety when appropriate.
• Chair working group and vendor status update meetings and ensure meeting minutes are completed, distributed to team members, and filed in the Regulatory Binders in a timely manner.
• Monitor the quality of vendor deliverables, address quality issues with the appropriate team member and identify opportunities to improve training, execution and quality control across the clinical team
• Review and approve vendor invoices in collaboration with the Accounting team to ensure Solis payments occur in a timely manner
• Review and approve vendor responses to quality assurance audits for appropriateness, timeliness and accordance with company SOPs and regulatory requirements.
• Ensure all project level study documentation is filed in the Regulatory Binders in accordance with company SOPs/all regulatory requirements and provide oversight to the clinical team regarding TMF filing, maintenance and archival procedures
• Effectively provide support to Clinical Research Coordinators (CRC) and site staff in the conduct of the trials

SKILLS/QUALIFICATIONS:

  • Must have a thorough knowledge of clinical research concepts, practices, and FDA regulations and ICH Guidelines regarding drug development phases, clinical research and data management methods.
  • Demonstrated experience building, maintaining and leading team efforts to achieve compliance and integrity of clinical research.
  • Demonstrated facilitation and presentation skills
  • Advanced oral and written communication skills
  • Multi-project management skills
  • Must be able to travel 25% -50% of the time
  • Bachelor's degree preferred; in a field, relevant to clinical research
    • Master's degree preferred
  • 3-5 years' experience in managing clinical research studies; device and imaging study experience a plus

Solis Mammography/ Washington Radiology

Address

Addison, TX
75001 USA

Industry

Healthcare

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