Job Description

The Clinical Trial Manager (CTM) will support successful and timely start-up and completion of clinical trials and is a key member of the Organization of Chief Medical Officer (OCMO) Global Clinical Affairs team. This includes managing the day-to-day execution of clinical studies for in vitro diagnostics (IVDs) and medical devices (MDs) ensuring Good Clinical Practice (GCP), and adherence to Agilent procedures, and all applicable regulations. The CTM will build strong internal and external relationships, including with clinical sites, and collaborate with cross functional team members. The CTM will report to a Clinical Operations Manager, Senior Manager, or Director, depending on level and needs of the business.

Primary Responsibilities:

Manage, design and implement all clinical operational aspects of IVD clinical trials from inception through close-outServe as main point of contact for internal and external study stakeholders; effectively communicating, collaborating, managing escalation of issues, where necessary, as well as participating and leading internal and external study meetingsIdentify, evaluate, and oversee qualification and contracting for study investigators, study sites, CRO and/or vendor management for the study, where applicableDevelop or assist in the development of study-related plans and documents including protocols, informed consent forms, monitoring plans, case report forms, training plans and engagement materialsEnsure trial master file (TMF/eTMF) is established, current, and maintained per ICH E6(R2). May coordinate study IRB/EC approvalsSupport and oversee study-related work of Clinical Research Associates (CRAs) to ensure proper site training and management, provide ongoing oversight of clinical site compliance with study plans, study protocol, internal SOPs, FDA CFR, ICH/GCP guidelines, and in compliance with all applicable regulations. Demonstrate compliance with and enforcement of these regulations and requirementsManage study deliverables and track study metrics including identifying potential risks to study timelines and/or conductReview, suggest edits and approve monitoring trip reports for studies. Escalate issue and/or findings to senior management and/or leadership according to risk/severity.Participate in data management activities, such as CRF development, training, and facilitating query resolutionLead or contribute to organizational and departmental process development, improvement, and implementationProvide guidance and mentorship to junior team members.

In addition to the primary responsibilities, CTM will also be expected to take on the following responsibilities:

Capable of managing a project of notable complexity and critical to business. Work under general direction with the ability to solve a variety of problems of moderate scope and complexity against more general specificationsExercise authority and judgement within defined limits to determine appropriate action, with understanding that failure to achieve results, or erroneous decisions or recommendations may cause delays in trial schedules, data integrity or compliance, and may results in allocation of additional resourcesIdentify objectives of an assignment, independently plan work, determine and develop the approach to a solution, and identify tasks that should be delegatedModel and contribute to high standards of performance from project teamLead and work with the project team to identify risks, mitigations and outcomes; present findings to management and implement basic mitigation.Monitor and review study budget and data management activities, such as PRF development, training, and facilitating query resolution with proper documentationSupport monitoring efforts by setting quality and compliance goals by overseeing and approving study monitoring plans, may review, suggest edits and approve monitoring trip reportsContribute to contract review and negotiations with outside vendors and study sites or laboratoriesMentor CTMs and CRAsDemonstrate an ability to influence others to achieve positive results and collaboration through diplomacy and respect for others, appropriate prioritization and facilitation of the decision-making process

Qualifications

Bachelor's degree or higher, or equivalent credentialsKnowledge of GCP, ICH guidelines, and other clinical regulatory requirementsStrong 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 environmentStrong work ethic and ability to deliver tasks on timeProficient with office automation tools, especially Microsoft PowerPoint, Excel and Word.People management skills1+ year of direct clinical study management experience or 5+ years of direct clinical operations experience with sponsor, CRO and/or companion diagnostics, device manufacturer, IVD, or similar industry(ies) demonstrating management or study lead experience with a track record of successful trial initiation and execution, or equivalent experience.

Travel:

Travel may be required up to 30%

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Additional Details

This job has a full time weekly schedule. It includes the option to work remotely. Applications for this job will be accepted until at least August 27, 2025 or until the job is no longer posted.

The full-time equivalent pay range for this position is $100,720.00 - $188,850.00/yr plus eligibility for bonus, stock and benefits. Our pay ranges are determined by role, level, and location. 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. Pay and benefit information by country are available at: https://careers.agilent.com/locations

Agilent Technologies, Inc. is an Equal Employment Opportunity and Affirmative Action employer. We value diversity at all levels. All individuals, regardless of personal characteristics, are encouraged to apply. All qualified applicants will receive consideration for employment without regard to sex, pregnancy, race, religion or religious creed, color, gender, gender identity, gender expression, national origin, ancestry, physical or mental disability, medical condition, genetic information, marital status, registered domestic partner status, age, sexual orientation, military or veteran status, protected veteran status, or any other basis protected by federal, state, local law, ordinance, or regulation and will not be discriminated against on these bases. Agilent Technologies, Inc., is committed to diversity in the workplace and strives to support candidates with disabilities. If you have a disability and need assistance with any part of the application or interview process or have questions about workplace accessibility, please email job_posting@agilent.com or contact +1-262-754-5030. For more information about equal employment opportunity protections, please visit www.agilent.com/en/accessibility.

Travel Required: 25% of the Time

Shift: Day

Duration: No End Date

Job Function: Medical/Clinical