Clinical Trial Manager

Company : Adaptive Phage Therapeutics

Country: United States

Location : Gaithersburg, Maryland

Post: Mon, 20 Sep 2021 06:29:49 GMT

Expires: Mon, 18 Oct 2021 23:59:59 GMT

Apply Job : Apply Online

—————————— Job Description ——————————

Overview:
Exciting opportunity for an experienced Clinical Trial Manager (CTM) to join the team at Adaptive Phage Therapeutics, Inc. (APT). The CTM, in concert with the Director, Clinical Operations, will manage the coordination of deliverables for assigned projects. The candidate must be knowledgeable of clinical research operations, including interpretation and implementation of FDA regulations/ICH guidelines. The individual will be expected to work on-site. The position will report to Director, Clinical Operations.

Responsibilities:
• Proactively manage project level operational aspects of the clinical team including management of trial timeline, resources, and vendors.
• Provide efficient updates on trial progress to the Director, Clinical Operations with respect to project plans, timeline management, quality standards, and risk mitigation.
• Manage sponsor study startup process, including but not limited to conduct of the Trial Kick-off meeting, the set-up of trial master file (TMF), development of CRFs, and site selection activities.
• Ensure effective project plans are in place and operational for each trial and work proactively with the clinical team to set priorities in accordance with applicable project plans, company standard operational procedures (SOPs), ICH/GCP guidelines, and regulatory requirements.
• Ensure potential study risks are escalated to the attention of the Director, Clinical Operations when appropriate.
• Review and approve site visit reports; ensure tracking, follow up and resolution of site issues have been completed in a timely manner.
• Monitor the quality of vendor deliverables, reporting any quality issues, identifying opportunities to improve training and execution with the Director, Clinical Operations.
• Review and approve vendor responses to quality assurance audits for appropriateness, timeliness, and accordance with company SOPs and regulatory requirements.
• Ensure all project level study documentation is filed in the TMF in accordance with company SOPs/all regulatory requirements and provide oversight to the clinical team regarding TMF filing, maintenance, and archival procedures.

Qualifications:
• Bachelor’s degree in nursing, science, or health related field required
• Minimum 5 years of clinical research experience.
• 2+ years of clinical operations experience with increasing levels of responsibility, in the Pharmaceutical, Biotechnology, Medical Device, or CRO industry is required.
• 4+ years of clinical project management experience at a sponsor or CRO company is required.
• Experience in early phase trials (Phase I-II) and First-In-Man trials.
• Fluency with regularly used Microsoft software applications (Word, Excel, Project, PowerPoint, SharePoint).
• Excellent verbal and written communication skills

Compensation: Salary is industry-standard and is commensurate with experience.
 

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