Sr. Clinical Trials Manager

Agilent Technologies

7d•Remote

About The Position

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 (all levels): • Manage, design and implement all clinical operational aspects of IVD clinical trials from inception through close-out • Serve 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 meetings • Identify, evaluate, and oversee qualification and contracting for study investigators, study sites, CRO and/or vendor management for the study, where applicable • Develop 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 materials • Ensure trial master file (TMF/eTMF) is established, current, and maintained per ICH E6. May coordinate study IRB/EC approvals • Support 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 requirements • Manage study deliverables and track study metrics including identifying potential risks to study timelines and/or conduct • Review, suggest edits and approve monitoring trip reports for studies. Escalate findings to senior management and/or leadership according to risk/severity. • Participate in data management activities, such as CRF development, training, and facilitating query resolution • Lead or contribute to organizational and departmental process development, improvement, and implementation • Provide guidance and mentorship to junior team members. In addition to the primary responsibilities, the Sr 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 specifications • Exercise 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 resources • Identify objectives of an assignment, independently plan work, determine and develop the approach to a solution, and identify tasks that should be delegated • Model and contribute to high standards of performance from project team • Lead 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 documentation • Support monitoring efforts by setting quality and compliance goals by overseeing and approving study monitoring plans, may review, suggest edits and approve monitoring trip reports • Contribute to contract review and negotiations with outside vendors and study sites or laboratories • Mentor CTMs and CRAs • Demonstrate 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

Requirements

Bachelor's degree or higher, or equivalent credentials
Knowledge of GCP, ICH guidelines, and other clinical regulatory requirements
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, especially Microsoft PowerPoint, Excel and Word.
For Sr CTM: 5+ years of clinical study management experience in sponsor, CRO and/or companion diagnostics, device manufacturer, IVD, or similar industry(ies) demonstrating effective and successful study management from study inception through close-out.

Nice To Haves

Experience in line management of CRAs and CTMs preferred.

Responsibilities

Manage, design and implement all clinical operational aspects of IVD clinical trials from inception through close-out
Serve 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 meetings
Identify, evaluate, and oversee qualification and contracting for study investigators, study sites, CRO and/or vendor management for the study, where applicable
Develop 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 materials
Ensure trial master file (TMF/eTMF) is established, current, and maintained per ICH E6. May coordinate study IRB/EC approvals
Support 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 requirements
Manage study deliverables and track study metrics including identifying potential risks to study timelines and/or conduct
Review, suggest edits and approve monitoring trip reports for studies. Escalate findings to senior management and/or leadership according to risk/severity.
Participate in data management activities, such as CRF development, training, and facilitating query resolution
Lead or contribute to organizational and departmental process development, improvement, and implementation
Provide guidance and mentorship to junior team members
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 specifications
Exercise 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 resources
Identify objectives of an assignment, independently plan work, determine and develop the approach to a solution, and identify tasks that should be delegated
Model and contribute to high standards of performance from project team
Lead 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 documentation
Support monitoring efforts by setting quality and compliance goals by overseeing and approving study monitoring plans, may review, suggest edits and approve monitoring trip reports
Contribute to contract review and negotiations with outside vendors and study sites or laboratories
Mentor CTMs and CRAs
Demonstrate 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