Clinical Trial Manager
3 weeks ago
The Clinical Trial Manager will play a key role in the successful execution of clinical trials, working closely with 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 regulations.
Key Responsibilities:- Design and implement clinical operational aspects of IVD clinical trials from inception through close-out.
- Serve as the main point of contact for internal and external study stakeholders, effectively communicating and collaborating to manage issues and participate in study meetings.
- Identify, evaluate, and oversee qualification and contracting for study investigators, study sites, CRO and/or vendor management for the study.
- 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 the trial master file (TMF/eTMF) is established, current, and maintained per ICH E6(R2), and may coordinate study IRB/EC approvals.
- Support 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 applicable regulations.
- Manage study deliverables and track study metrics, identifying potential risks to study timelines and/or conduct.
- 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.
- 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.
- People management skills.
- For CTM: 1+ year of direct clinical study management experience or 4+ 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.
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