Manager, Clinical Research

Summary

AMF is currently accepting applications for a Clinical Research Manager for a full-time position (hybrid) based in Valencia, CA. This position plays an essential role in the development, administration and oversight of clinical research activities and management of clinical resources.

Responsibilities

Responsibilities include providing oversight and project management of clinical trials and daily oversight of clinical resources. This position plays a key role in the development and execution of pre-clinical, First in Human and pivotal studies intended to support regulatory registration of new indications and new devices, as well as physician-initiated and company sponsored, and grant funded clinical trials.

• Management of US/OUS Class III medical device studies in line with GCP, Regulatory and Compliance Requirements.
• Responsible for monitoring clinical trials and work closely with all clinical project teams to establish protocol-specific practices.
• Handles duties related to the execution of a Clinical Trial from protocol study design to the final clinical study report for one or several studies.
• Provides daily oversight and management of study teams, CROs and maintains site and KOL relationships.
• Drives all aspects of the project management process from initiation, planning, execution, control to closure.
• Works with cross-functional teams including R&D, Quality and Regulatory to ensure study objectives and timelines are met.
• Assumes overall responsibility for the preparation of protocols and Case Report Forms, finalization of monitoring and data management options (either in-house or contracted to a Contract Research Organization), development of recruitment strategies to increase patient randomization into the trial, the provision of clinical trial materials, and management of the trial.
• Coordinates the smooth monitoring of all trials, establishing audit procedures and ensuring that cleaned data is entered into the database in a timely fashion.
• Trains field clinical engineers, physicians on study protocols.
• Provides back-up support for other projects on an as needed basis.

Minimum Requirements

• BS or MS degree in Life Sciences, Engineering or a related field
• SoCRA or ACRP Certification preferred.
• >8 years of experience in managing Class III medical device clinical trials and clinical resources.
• >8 years of experience conducting site-monitoring visits, performing source document verification and reviewing protocol compliance
• 3+ years of experience working in Industry
• Excellent knowledge of clinical study guidelines (FDA, ICH and GCP).
• Excellent time management and writing skills (emails, letters, reports, publications, internal and external communications.)
• Proven track record of effectively working with clinical sites.
• Experienced in writing protocols and other technical documents.
• Experienced in reviewing clinical data including classification of AEs and timely reporting of UADEs.
• Experienced in planning and driving investigator meetings, Steering Committee and DSMB meetings.
• Excellent communication (written and oral) and vendor-management skills.
• Proven leadership, excellent problem-solving, organizational, and interpersonal skills.
• Ability to utilize various electronic systems and software- intermediate computer skills required
• Ability to travel (< 20%) as required US/OUS.

Additional Experience a plus

• Experience with neuromodulation trials. #LI-On-Site

9/80 Work Week