Clinilabs

Corelab Project Manager

Clinilabs

full-time

Posted on:

Location Type: Remote

Location: United States

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Salary

💰 $65,000 - $100,000 per year

About the role

  • Serve as Corelab Project Manager on studies, and/or site certification, device management, scoring reliability.
  • Provide leadership and guidance to Data Coordinators.
  • Create training & delegation of responsibilities documents for support staff.
  • Provide support and act as the point person to the Sponsor, CROs, vendors, clinical sites, and scorers for questions regarding core lab data management.
  • Develop and maintain good communications and working relationships with Clinilabs project team members as well as Sponsor, CRO, vendor, and clinical site project team members.
  • Manage and track project timelines and quality issues.
  • Develop training and reference materials and/or presentations as needed.
  • Develop study-specific SOPs.
  • Coordinate and manage training, documentation, and communication with stakeholders.
  • Maintain and manage budget/finance tracker, and change order management.
  • Evaluate and analyze data submitted by various parties to ensure it meets the criteria set by the study protocol.
  • Monitor and update study database to ensure that all data is being processed in a timely manner.
  • Perform data entry and data QC.
  • Perform query generation and tracking and oversee query resolution.
  • Create a study-specific electronic regulatory binder and screening binders, where applicable.
  • File and store documents according to protocol.
  • Track study progress and issue periodic status reports as needed.
  • Manage and track study device database.
  • Assist in the creation and documentation of new or revised data management, IT and quality assurance procedures.
  • Communicate with all operational departments regarding project status/issues.

Requirements

  • The position requires at least 5 years of experience in a Data Coordinator role and/or comparable roles.
  • A bachelor’s degree is strongly preferred.
  • Strong computer (Microsoft Windows and Office Applications) and communication (oral and written) skills are required.
  • Must have detailed documentation and project management skills.
Applicant Tracking System Keywords

Tip: use these terms in your resume and cover letter to boost ATS matches.

Hard Skills & Tools
data managementproject managementdata entrydata quality controlquery generationSOP developmentbudget managementtimeline trackingdata analysisdocumentation
Soft Skills
leadershipcommunicationteam collaborationtrainingdelegationrelationship managementproblem-solvingorganizational skillsattention to detailinterpersonal skills