Senior Clinical Research Specialist

Overview

Our client is a global leader in medical device innovation focused on advancing patient care through breakthrough technologies. The Senior Clinical Research Specialist will support the execution of one or more company-sponsored clinical trials while fostering strong, productive cross-functional relationships.

This position plays a critical role in the planning, execution, oversight, and close-out of clinical trials, ensuring delivery against timelines, budgets, and regulatory requirements in accordance with ICH-GCP, applicable legislation, and company SOPs.

• Serve as a Senior Clinical Research Specialist within the Clinical R&D Department, supporting execution of company-sponsored clinical trials in compliance with timelines, milestones, regulations, and SOPs.
• Provide oversight and execution of clinical trial feasibility, site selection, study startup, conduct, and close-out within assigned countries.
• Act as a primary point of contact for clinical trial sites, including site management and ongoing communication.
• Contribute to the development of key clinical trial documents such as protocols, informed consent forms, case report forms (CRFs), monitoring plans, study manuals, investigator brochures, annual reports, and publications.
• Ensure clinical trial registration and results posting on Clinical Trials.gov from study initiation through completion.
• Manage and/or oversee investigational product ordering, tracking, accountability, and trial material logistics.
• Interface and collaborate with investigators, site staff, IRBs/ECs, vendors, contractors, and internal company partners.
• Oversee development and execution of investigator agreements and trial-related payments.
• Perform clinical data review activities in preparation for statistical analyses and scientific publications.
• Conduct monitoring activities as applicable, including site qualification, site initiation, interim monitoring, and close-out visits.
• Contribute to global Evidence Generation Strategies (EGS) and Evidence Dissemination Strategies (EDS), as assigned.
• Provide on-site protocol compliance and procedural support to investigational centers when required.
• Support critical literature assessment and interpretation of clinical evidence generated.
• Partner effectively with study core teams to deliver clinical project milestones on time, within budget, and in compliance with applicable regulations.
• Communicate business-related issues and opportunities to management and function as a trusted clinical project resource for stakeholders.
• Support study and project budget activities as assigned.
• Develop a strong understanding of the clinical pipeline, product portfolio, and business needs.
• Ensure personal and organizational compliance with all federal, state, local, and company regulations, policies, and procedures.
• Perform other duties as assigned.
• Operate with increasing independence for routine and moderately complex decisions, while escalating complex issues as appropriate.

• Bachelor’s degree required, preferably in Life Science, Physical Science, Biological Science, or Nursing.

• Bachelor’s degree with 2–4 years of relevant experience,
• Master’s degree with at least 3 years of experience, or
• PhD with at least 2 years of relevant experience preferred.
• Prior experience in clinical research or an equivalent clinical environment required.
• Medical device clinical research experience strongly preferred.
• Clinical or medical background a plus.
• Relevant professional certifications preferred (e.g., CCRA, CCRC, CCRP, RAC, CDE, GCP, ISO 14155, MDR, MEDDEV).

• Strong working knowledge of clinical research processes, regulatory requirements, and global clinical trial standards.
• Proven ability to support and deliver clinical projects on time, within budget, and in compliance with regulations and SOPs.
• Excellent written, verbal, presentation, and technical writing skills.
• Strong organizational skills with the ability to manage multiple priorities.
• Ability to lead small study teams and support delivery of critical milestones.
• Demonstrates leadership in alignment with Johnson & Johnson Leadership Imperatives:
• Co…