huMannity Medtec ยท 1 day ago
Manager, Clinical Research
Santa Clarita, CA
Full-time
Onsite
Senior Level, Lead/Staff
$115K/yr - $140K/yr
8+ years exphuMannity Medtec is currently accepting applications for a Clinical Research Manager for a full-time position 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.
Health CareHospitalMedical
Responsibilities
Provide 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 working 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
Qualification
Required
BS or MS degree in Life Sciences, Engineering or a related field
>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
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 travel (< 20%) as required US/OUS
Preferred
SoCRA or ACRP Certification
Benefits
9/80 schedule with every other Friday off
26 long weekends a year
Company
huMannity Medtec
huMannity Medtec provides medical conditions.
51-200 employees
Funding
Current Stage
Growth StageLeadership Team
Anthony Ng
Director of Electrical Engineering
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