Remote Clinical Trial Manager
Company: Beacon Hill Staffing Group
Posted on: January 16, 2022
Responsible for operational aspects of planning and management of
site performance in accordance with departmental expectations. May
act as primary liaison between in-house CRAs, field based CRAs and
the Clinical Project Manager (CPM). Supports and assists Clinical
Project Managers in operationalizing multiple clinical research
--- Under supervision may participate/lead in CRA project-specific
--- Supports preparation and development of materials related to
the training and presentations for Investigator Meetings.
--- Facilitates CRA project meetings.
--- Assist in the oversight of monitoring staff including the
tracking and review of monitoring trip reports and escalate any
trends with respect to data quality or study conduct to the
--- Track and report on progress of the study including site
activation, patient enrollment and monitoring visits.
--- Ensures that all sites are provided supplies in accordance with
--- Identify potential risks to the enrollment targets based on
feasibility analysis in collaboration with the CPM
--- Develop PSV /SIV/IMV presentation and other training tools and
training materials in support of the project.
--- Review and approve PSV/SIV/IMV presentation and other training
tools and training materials in support of the project.SR CTM
--- Assist in the review of CRO and other third party vendor
invoices to ensure that work is performed in accordance with scope
--- Ensure that monitoring visits are performed in accordance with
the protocol, monitoring plan, and applicable company SOPs.
--- Under supervision may develop and/or monitor budget for
clinical study (investigational sites and vendors)
--- Responsible for operationalizing clinical protocols at the site
level and ensuring appropriate SOPs are being followed for each
process, depending on the study.
--- Assists in oversight of the identification and selection of
--- Contributes to the clinical review of Case Report Forms, User
Acceptance Testing (UAT) and corresponding completion
--- Assists and/or participates in planning and conduct of
--- Work with CRAs in proactively maintaining / up-dating essential
documents as required, to ensure compliance with protocol and
--- Contact sites as needed for data entry/data quality concerns
and alert CRA of any issues prior to the next scheduled monitoring
--- Responsible for study start-up activities including development
of the first draft of the ICF.
--- Assist with the review of protocol, protocol amendments, ICF
and CSR documents as required.
--- Provide active mentorship of CTA staff to build talent across
--- Agenda distribution & minute taking for internal study team
--- Up to 20% domestic and/or international travel may be
--- Bachelor's degree or nursing qualification is required.
Scientific/health care field preferred, but not required.
--- Experience (4 to 6 years) working in relevant clinical research
preferably in clinical operations within a pharmaceutical company
or CRO or similar organization.
--- Requires strong attention to detail in composing and proofing
materials, establishing priorities, scheduling and meeting
--- Must be able to work in a fast paced environment with
demonstrated ability to juggle multiple competing tasks and
--- Ability to work successfully within a cross-functional
--- Strong knowledge of applicable computer and project management
--- Excellent written and oral communication skills.
--- Ability to interact with investigators, vendors, and internal
--- Strong communication skills for interactions with
investigators, vendors, and internal colleagues.
--- Knowledge of current regulatory requirements and guidelines
governing clinical research and GCP
--- Ability and identifying tasks and deadlines to resolve/escalate
problems in a timely manner
Keywords: Beacon Hill Staffing Group, Dallas , Remote Clinical Trial Manager, Executive , Dallas, Texas
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