Clinical Trials Manager (W2 and Local only)
Company: Sharp Decisions
Location: San Mateo
Posted on: February 2, 2025
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Job Description:
A client of Sharp Decisions Inc. is looking to hire a Clinical
Trials Manager to be based in Foster City, CA. The position is
HYBRID (3 days a week onsite). The contract's duration is 6 months
with possible extension. *W2 and Local only.
Make sure to apply quickly in order to maximise your chances of
being considered for an interview Read the complete job description
below.
POSITION OVERVIEW:
You will work with and collaborate with Clinical Operations,
Biomarker Sciences, Clinical Pharmacology and other
cross-functional team members. You will manage certain components
of clinical studies and act as a member of the study team. You will
also manage biomarker and bioanalytical vendors. You will assist in
the review of clinical study protocols and other study documents,
contribute to process development and/or participate in special
projects. You may also participate in strategic initiatives.
RESPONSIBILITIES:
Serves as the key biomarker and bioanalytical operational (BBOps)
contact with internal and external stakeholders, for successful
implementation of biomarker and bioanalytical strategies.
Participate in multiple Phase 1-4 clinical study teams
Plans and coordinates all operational activities required with the
collection, delivery and analysis of biological specimens within a
clinical trial
Provides sample management expertise to the Study Management Teams
(SMTs), Biomarker SubTeams (BSTs), and Clinical Pharmacology
Subteams (CPST)
Accountable for ensuring biological samples collected are of good
analyzable quality and are collected in adherence to the highest
standards of ethics and informed consent.
Primary interface for operational activities between the SMT and
laboratory vendors; Provides the day-to-day operational management
of vendors to ensure delivery data against contracted scope of
work
Has ability to critically evaluate scientific proposal or protocol,
and budget for clinical operation feasibility
Establishes strong cross-functional relationships and exhibits
strong leadership skills with counterparts in other functional
teams (e.g., Biomarker Sciences, Vendor Outsourcing, Clinical
Operations, and Data Management) to ensure efficient execution of
the study biomarker strategy.
Proactively identifies potential operational challenges and in
collaboration with senior team members provides resolution plans to
ensure biomarker strategy remains on track
Organizes and leads Biomarker and Bioanalytical operational
meetings with study functional groups or vendors
Maintains internal Biomarker and Bioanalytical Operations databases
and document repositories
Review of relevant documents including protocols, informed
consents, and relevant study documents
Must be able to understand, interpret and explain protocol
requirements to others
Assists in determining the activities to support a projects
priorities within functional area
Contributes to development of RFPs and participates in selection of
CROs/vendors
Able to examine functional issues from an organizational
perspective
May contribute or participate in special projects.
Develops tools and processes that optimize project efficiencies and
effectiveness.
Participates in the recruiting and hiring process for CPA/CTMA/Sr.
CTMA and support their professional development
Minimum Education & Experience
PharmD / PhD with 2+ years relevant clinical or related experience
in life sciences.
MA / MS with 3+ years relevant clinical or related experience in
life sciences.
BA / BS / RN with 5+ years relevant clinical or related experience
in life sciences.
Meets all requirements for Senior Clinical Trial Management
Associate (Senior CTMA) grade 26 position with demonstrable
proficiency.
Keywords: Sharp Decisions, San Mateo , Clinical Trials Manager (W2 and Local only), Healthcare , San Mateo, California
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