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Manager, Clinical Monitoring

Remote: 
Full Remote
Contract: 
Experience: 
Senior (5-10 years)
Work from: 

Offer summary

Qualifications:

BA/BS or nursing qualification, 7 years experience in CRO/Sponsor, Previous clinical monitoring experience preferred, Previous line management experience preferred, Extensive clinical research experience.

Key responsabilities:

  • Supervise and develop CRAs and/or CTMs
  • Ensure quality data and compliance
  • Drive business development activities
  • Conduct training and allocate project resources
  • Manage performance assessments and compliance
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Caidya Biotech: Biology + Technology Large https://www.caidya.com/
1001 - 5000 Employees
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Job description

Job Description:

Job Title: Manager, Clinical Monitoring

Job Location: Home Based (United States)

Job Overview:

Supervises and is responsible for the growth and development of a group of CRAs and/or CTMs. Ensures quality and integrity of data, compliance with CP or Sponsor SOPs, ICH-GCP and regulatory requirements, delivering study completion on time and within budget; Supports business development activities; responsible for the integration of CP operational processes across Clinical Monitoring and the management of operational metrics.

Job Duties and Responsibilities:

  • Provides guidance and oversight to the regional Clinical Monitoring team (CRAs and/or CTMs) to ensure adherence to project scope, SOPs, timelines, and budget requirements.
  • Supports the identification of regional clinical monitoring resources, and ongoing management of project allocation & utilization
  • Responsible for compliance - ensuring CRAs and/or CTMs achieve role specific KPIs and meet project deliverables
  • Review of time and expenses
  • Supports recruitment through conduct of initial screening, phone and face-to-face interviews of potential CRAs and/or CTMs.
  • Responsible for the on boarding and training of new CRA/CTM hires
  • Supports regional training, quality initiatives, and review of metrics to ensure consistent service delivery.
  • Responsible for the ongoing training & development of CRAs and/or CTMs
  • Conducts annual appraisals and other ongoing assessments, including sign off and site assessment visits for CRAs. Develops and communicates corrective action plans for employees identified with performance issues.
  • Assures regional compliance to corporate Standard Operating Procedures (SOPs), ICH GCPs and other regulatory requirements through active performance management, quality control checks and project metrics analysis.
  • Assures timely submission of clinical project metrics for region.
  • Contributes to the development, revision, and improvement of current work processes with global counterparts
  • Contributes to company-level initiatives as they relate to Clinical Monitoring and ensures department needs are represented.
  • Attends and contributes in departmental, regional, and company meetings as required
  • Supports business development and sales, including review of RFPs/budgets & proposals, support of staff attending BDMs, and participation at conferences, tradeshows, and BDMs as required

Supervisory Responsibilities:

Direct line management of CRAs and/or CTMs and provision of work direction and guidance.

Job Requirements:

  • Education
    • BA/BS, nursing qualification, or equivalent educational experience
  • Experience
    • 7 years within CRO/Sponsor
    • Previous experience within clinical monitoring preferred
    • Previous line management experience preferred
    • Extensive experience of clinical research
  • Skills/Competencies
    • Experience working in a team environment under time and resource pressures
    • Strong leadership and management skills
    • Ability to manage workload, staff allocation, quality, and project budgets
    • Understanding of the principles of project management, including finances
    • Excellent Communication skills, written and verbal
    • Team player – effective participant as a team member and team leader
    • Creative, change agent – leader in pursuing positive improvements
    • Practices professionalism and integrity in all actions
  • Capabilities
    • Ability to work remotely.
    • Ability to negotiate effectively, resolve conflicts and build consensus.
    • Ability to travel as required.
The company will not accept unsolicited resumes from third party vendors.

Required profile

Experience

Level of experience: Senior (5-10 years)
Industry :
Biotech: Biology + Technology
Spoken language(s):
English
Check out the description to know which languages are mandatory.

Other Skills

  • Leadership
  • Creative Problem Solving
  • Quality Control
  • Time Management
  • Training And Development
  • Verbal Communication Skills
  • Team Management

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