Lead Site Manager - Early Development

Johnson & Johnson Innovative Medicine R&D is recruiting for a Lead Site Manager - Early Development.

This position can be located remotely within the United States, preferably in the Southeast region.

At Johnson & Johnson, we believe health is everything.

Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal.

Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity.

Learn more at https://www.jnj.com/

For more than 130 years, diversity, equity & inclusion (DEI) has been a part of our cultural fabric at Johnson & Johnson and woven into how we do business every day.

Rooted in Our Credo, the values of DEI fuel our pursuit to create a healthier, more equitable world.

Our diverse workforce and culture of belonging accelerate innovation to solve the world's most pressing healthcare challenges.

We know that the success of our business - and our ability to deliver meaningful solutions - depends on how well we understand and meet the diverse needs of the communities we serve.

Which is why we foster a culture of inclusion and belonging where all perspectives, abilities and experiences are valued and our people can reach their potential.

At Johnson & Johnson, we all belong.

The Lead Site Manager - Early Development will serve as a primary contact point between the sponsor and the investigational site (both commercial and hospital) for the conduct complex early development and/or clinical pharmacology (ED&CP) studies.

This individual will be assigned to trial sites ensuring inspection readiness through compliance with the clinical research protocol, company's Standard Operating Procedures (SOPs), codes of Good Clinical Practice (GCP), Healthcare compliance (HCC) requirements, applicable regulations and guidelines from start-up through data-base lock.

This role will be responsible for site assessments, pre-trial assessments, site selection, site initiation, subject recruitment and retention, monitoring and close-out.

Partner with the Clinical Trial Assistant (CTA), Trial Manager (TM), Site Strategy Lead (SSL) and Trial Delivery Leader (TDL) to ensure overall site management while performing trial related activities for assigned protocols.

The Lead Site Manager is expected to have outstanding capability to engage with key sites and build strong relationships with important sites involved in the clinical trials.

Lead process improvements at country, regional, and global levels, as well as train and mentor other Site Managers.

Oversee, train, and mentor more junior Site Managers when required.

As a supervisor, this individual will guide and support the development of less experienced team members.

Principal Responsibilities:


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