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The Senior Clinical Trial Manager (Sr. CTM) will support ongoing and new clinical trials and be a key member of the clinical affairs team. This will include managing the planning and day-to-day execution of clinical studies for in vitro diagnostics (IVDs) and medical devices (MDs) if applicable, ensuring operating procedures and company policies are followed. The Sr. CTM will build strong internal and external relationships, manage clinical sites, and collaborate with cross functional teams. The Sr. CTM will report to a Clinical Director and will have direct reports assigned.
Manage operational aspects of IVD clinical trials from start-up through enrollment, maintenance, and close-out.
Serve as main point of contact for internal and external study stakeholders. Effectively communicate and collaborate with stakeholders, including managing escalation of issues, where necessary. Participate and lead internal and external study meetings.
Performs site qualification visits of potential investigator sites in conjunction with Quality Assurance.
Identify, evaluate, and oversee qualification and contracting for sites and CRO/vendor management for the study
Develop or facilitate development of study-related plans and documents including protocols, informed consent forms, monitoring plans, case report forms, and site training and engagement materials.
Ensure trial master file (TMF/eTMF) is established, current, and maintained. May coordinate study IRB/EC approvals.
Ensure proper site training and management, provide ongoing oversight of clinical site compliance with study plans, study protocol, SOPs, ICH/GCP guidelines, and in compliance with all applicable regulations. May support conduct of assay wet lab trainings.
Manage study deliverables and track study metrics, identify potential risks to study timelines and/or conduct, propose and implement mitigations with stakeholder support.
Oversee in data management activities, such as CRF development, training, and facilitating query resolution.
Manage CRAs and responsible for overall clinical study management. Manages resources to implement tactical business and project plans to support studies. Will develop and manage clinical budgets.
Lead organizational and departmental process development, improvement, and implementation.
Prepare, revise, and maintain procedures for the conduct of studies.
May participate in business development activities.
Travel may be required
Bachelor's degree or higher
5+ years of direct clinical operations experience in sponsor or CRO organizations, with a strong track record of successful trial initiation and execution
Solid understanding and experience with project management practices and tools
Direct experience with CRO/vendor management and contracting
Thorough knowledge of GCP, ICH guidelines, and other clinical regulatory requirements
Prior management experience highly preferred
Diagnostic/IVD experience highly preferred, oncology or other medical device experience is also accepted
Previous experience with NGS, IHC, or pathology highly preferred.
Prior experience working with high-complexity CLIA or CAP accredited laboratories conducting clinical trial testing is highly preferred
Certifications in project management (PMP, etc.) or clinical research (CCRA, CCRP, etc.) is highly preferred.
Working experience with electronic data capture (EDC) systems and eTMF systems preferred
Strong interpersonal skills (verbal and written), organizational, and prioritization skills, able to communicate at multiple levels of an organization and with sponsors/clients
Ability to work independently and effectively in a fast-paced environment
Strong work ethic and ability to deliver tasks on time
Proficient with office automation tools, such as Microsoft Office
The US pay range for this full-time position is $126,420.00 - $221,988.00/yr, plus eligibility for bonus, stock and benefits. Our pay ranges are determined by role, level, and location. The range displayed on each job posting reflects the minimum and maximum new hire pay for the position across the relevant US locations. Within the range, individual pay is determined by work location and additional factors, including job-related skills, experience, and relevant education or training. During the hiring process, a recruiter can share more about the specific pay range for a preferred location. Additional details are available at:
Agilent Technologies Inc. is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other protected categories under all applicable laws