SENIOR SITE MANAGER at Johnson & Johnson

Warsaw, Woj. Mazowieckie, Poland

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Not SpecifiedCompensation

Mid-level (3 to 4 years), Senior (5 to 8 years)Experience Level

Full TimeJob Type

UnknownVisa

Healthcare, Pharmaceuticals, MedTechIndustries

Requirements

Typically 3-5 years of experience in site management
Ability to operate independently with little or limited supervision
Knowledge of clinical trial protocol, company SOPs, Good Clinical Practice (GCP), and applicable regulations and guidelines
Ability to implement analytical risk-based monitoring model at the site level

Responsibilities

Acts as primary local company contact for assigned sites for specific trials
Actively may participate in site feasibility and/or Site Qualification Visit
Attends/participates in investigator meetings as needed, may be expected to help prepare meeting materials and may be required to present at the IM
Responsible for executing activities within site initiation and start-up, preparation and conduct of site monitoring (including remote monitoring), site management (by study specific systems and other reports/dashboards) and site/study close-out according to SOPs, Work Instructions (WIs) and policies
Responsible for the implementation of analytical risk-based monitoring model at the site level and to work with site to ensure timely resolution of issues found during monitoring visits
Ensures site staff are trained and the corresponding training records are complete and accurate at any time point during all trial phases
Responsible in close collaboration with LTM and central study team for the activities during site activation phase in order to speed up the process and activate the site in shortest possible timeframe
May be required to help provide solutions to challenges faced in other sites in the country
Contributes to site level recruitment strategy and contingency planning and implementation in partnership with other functional areas
Ensures site study supplies (such as Non-Investigational Product (IP), lab kits, etc.) are adequate for trial conduct
Ensures that clinical drug supplies are appropriately used, handled and stored and returns are accurately inventoried and documented
Arranges for the appropriate destruction of clinical supplies
Ensures site staff complete data entry and resolve queries within expected timelines
Ensures accuracy, validity and completeness of data collected at trial sites
Proactively ensures that all Adverse Events (AE)/Serious Adverse Events (SAEs)/Product

Skills

GCP

SOP

Clinical Trial Protocol

Site Management

Site Monitoring

Subject Recruitment

Site Initiation

Site Close-out

Regulatory Compliance

Process Improvement

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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