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Kelly Science, Engineering, Technology & Telecom · 1 day ago

Senior Site Manager

Irvine, CA

Full-time

Onsite

Senior Level

$120K/yr - $128K/yr

Kelly Science, Engineering, Technology & Telecom is seeking a Senior Clinical Research Specialist to support clinical trials within the Clinical R&D Department. The role involves ensuring compliance with timelines and study milestones while fostering relationships across the organization.

Staffing & Recruiting

Hiring Manager

Kellie Pharr

Responsibilities

Serve as a Senior Clinical Research Specialist within the Clinical R&D Department to support execution of company sponsored clinical trials, ensuring compliance with timelines and study milestones

Oversight/execution of feasibility, selection, set up, conduct and closure of a clinical trial within the allocated countries, in accordance with the ICH-GCP, applicable legislation and Company Standard Operating Procedures

Contribute towards development of clinical trial documents (e.g. study protocol, informed consents, CRF, monitoring plan, study manual, investigator brochure, annual reports,…. )

Ensure registration on www.clinicaltrials.gov from study initiation through posting of results and support publications as needed

Management/oversight of ordering, tracking, and accountability of investigational products and trial materials

Interface and collaborate with site personnel, IRBs/ECs, contractors/vendors, and company personnel

Oversee the development and execution of Investigator agreements and trial payments

Responsible for clinical data review to prepare data for statistical analyses and publications

May perform monitoring activities including site qualification visits, site initiation visits, interim monitoring visits or close out visits based on study need

May contribute to the development and delivery of appropriate global evidence generation strategies (EGS) and evidence dissemination strategies (EDS) within the assigned projects

Contribute to the critical assessment of the literature and to the interpretations and disseminations of all evidence generated

Contribute to delivery of assigned clinical projects, through effective partnership with the study core team leading to delivery of clinical project commitments (deliver on time, within budget and in compliance with regulations and SOPs)

Responsible for communicating business related issues or opportunities to next management level. Function as a reliable, trusted resource of accurate, up-to-date project knowledge as requested by key stakeholders

Support project/study budget activities as assigned

Develop a strong understanding of the pipeline, product portfolio and business needs