Clinical Research Leader - JJMT Neurovascular at Johnson & Johnson

Irvine, California, United States

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Not SpecifiedCompensation

Senior (5 to 8 years)Experience Level

Full TimeJob Type

UnknownVisa

MedTech, Healthcare, NeurovascularIndustries

Requirements

Knowledge of ICH-GCP, applicable legislation, and Company Standard Operating Procedures
Ability to comply with all applicable federal, state, and local laws/regulations and Corporate Johnson & Johnson procedures and guidelines
Willingness to work hybrid schedule (3 days a week on-site in Irvine, California)

Responsibilities

Serve as a Clinical Research Leader within the Clinical R&D Department to execute and manage company sponsored clinical trials, ensuring compliance with timelines and study milestones, for JNJ MedTech Neurovascular
Oversee/execute feasibility, selection, set up, conduct and closure of a clinical trial within the allocated countries
Serve as the primary contact for clinical trial sites (e.g. site management)
Develop clinical trial documents (e.g. study protocol, informed consents, CRF, monitoring plan, study manual, investigator brochure, annual reports)
Ensure applicable trial registration (e.g. on www.clinicaltrials.gov) from study initiation through posting of results and support publications as needed
Manage/oversee ordering, tracking, and accountability of investigational devices and trial materials
Interface and collaborate with site personnel, IRBs/ECs, contractors/vendors, and company personnel
Interface, collaborate and oversee Clinical Research Associates (CRAs)
Oversee and support the development and execution of Investigator agreements and trial payments
Be responsible for clinical data review to prepare data for statistical analyses and publications
Perform monitoring activities including site qualification visits, site initiation visits, interim monitoring visits or close out visits based on study need
Contribute to the development and delivery of appropriate global evidence generation strategies (EGS) and evidence dissemination strategies (EDS), with collaborative relationships with all relevant Clinical R&D partners and cross-functional partners (e.g. Global Strategic Marketing)

Skills

Clinical Research

Clinical Trials

Clinical Development

R&D

Neurovascular

MedTech

Trial Leadership

Stakeholder Management

Johnson & Johnson

Healthcare products in pharmaceuticals and devices.

About Johnson & Johnson

Johnson & Johnson operates in the healthcare sector with three main areas: pharmaceuticals, medical devices, and consumer health products. In the pharmaceuticals segment, the company develops prescription drugs for various medical conditions such as cancer and infectious diseases. The medical devices segment provides products used in surgeries and other medical procedures, while the consumer health segment offers over-the-counter products, including baby care and personal health items. Johnson & Johnson generates revenue through direct sales and partnerships, and it invests significantly in research and development to create new products that meet the needs of consumers and healthcare providers. The company stands out from competitors by emphasizing diversity, equity, and inclusion in its workplace, fostering an environment where employees can share their perspectives. Its goal is to improve patient outcomes and enhance the overall health and well-being of individuals globally.

New Brunswick, New JerseyHeadquarters

1886Year Founded

IPOCompany Stage

HealthcareIndustries

10,001+Employees

Risks

J&J faces a class action lawsuit in Australia over ineffective cold and flu medications.

Former J&J executives joining other firms could lead to increased competition.

Ongoing legal battles, like the lawsuit against Cigna, pose financial liabilities for J&J.

Differentiation

J&J operates in three segments: pharmaceuticals, medical devices, and consumer health.

The company invests heavily in R&D for innovative medical solutions and products.

J&J is committed to diversity, equity, and inclusion in its workplace culture.

Upsides

J&J's collaboration with Helsinki University Hospital focuses on value-based healthcare models.

The rise of personalized medicine offers J&J opportunities in targeted therapies.

Increased focus on digital health solutions presents expansion opportunities for J&J.

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