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

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