Sr. Clinical Trials Manager

Job Description

Agilent inspires and supports discoveries that advance the quality of life. We provide life science, diagnostic and applied market laboratories worldwide with instruments, services, consumables, applications and expertise. Agilent enables customers to gain the answers and insights they seek - so they can do what they do best: improve the world around us. Information about Agilent is available at www.agilent.com.

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.

Primary Responsibilities:

• 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

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Qualifications

• 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: https://careers.agilent.com/locations/americas/united-states/

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

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 see all of our notices for EEO below.

Travel Required

10% of the Time

Schedule

Schedule:Full time

Shift

Day

Duration

No End Date

Job Function

Quality/Regulatory