Lead Site Manager - Early Development

Johnson & Johnson; Raritan (NJ); Remote; USD 105,000 - 170,000; Full time

Job summary

An innovative firm is seeking a Lead Site Manager for Early Development to oversee clinical trials. This role requires a dynamic professional with a strong background in clinical trial monitoring and a passion for ensuring compliance with regulations. You will be the key liaison between the sponsor and investigational sites, ensuring readiness and adherence to protocols. Collaborating closely with a dedicated team, you'll manage site assessments, recruitment strategies, and data integrity. This position offers the opportunity to lead initiatives and make a significant impact in the field of clinical research, all while working remotely within the United States.

Qualifications

• 6+ years of clinical trial monitoring experience required.
• Strong knowledge of drug development and ICH-GCP essential.

Responsibilities

• Act as primary contact for sites and ensure compliance with protocols.
• Conduct site assessments, monitoring, and close-out activities.

Skills

Clinical Trial Monitoring

Leadership Skills

Communication Skills

Knowledge of ICH-GCP

Problem-Solving Skills

Education

Bachelor's degree in Health, Science or Nursing

Tools

Clinical Research Software

Data Management Systems

Job description

Job Description - Lead Site Manager - Early Development (2506236826W)

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.

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 of 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.

Key Responsibilities

• Participate in site assessments, conduct pre-trial site assessment visits and/or participate in study feasibility assessments, providing recommendations from local area about site/investigator selection in collaboration with the trial team.
• Act as primary contact for assigned sites for specific ED&CP trials and work closely with TM and trial central team regarding study progress and issue resolution.
• Attend/participate in investigator meetings as needed.
• Execute activities within site initiation and start-up, site monitoring, site management and site/study close-out per internal SOPs, other procedural documents and policies.
• Ensure site staff have current GCP and necessary protocol, compound and systems training to conduct the clinical trial.
• Contribute to site level recruitment strategy and contingency planning and implementation in partnership with other functional areas to achieve clinical research targets.
• Ensure site study supplies (such as Non-IP, lab kits, etc.) are adequate for trial conduct.
• Ensure that clinical drug supplies are appropriately handled, administered, and stored.
• Ensure site staff complete the data entry and resolve queries within expected timelines.
• Ensure accuracy, validity and completeness of data collected at trial sites.
• Ensure that all Adverse Events (AE)/Serious Adverse Events (SAE)/Product Quality Complaints (PQC) are reported within the required reporting timelines.
• Maintain complete, accurate and timely data and essential documents in systems utilized for trial management.
• Fully document trial related activities with respect to study monitoring.
• Collaborate with TM for documenting and communicating site/study progress and issues to trial central team.
• Attend regularly scheduled team meetings and trainings.
• Work closely with TM to ensure Corrective Action Preventive Action (CAPA) is completed for quality assurance site audits or inspection.
• Prepare trial sites for close out, conduct final close out visit.
• May review and manage site specific informed consent forms in accordance with Global Clinical Operations (GCO) SOPs.
• Track costs at site level and ensure payments are made, if applicable.
• Establish and maintain good working relationships with internal and external stakeholders.

Qualifications

• A minimum of a Bachelor’s degree is required, preferably in a Health, Science or Nursing (RN) discipline.
• A minimum of 6 years of clinical trial monitoring experience is required.
• Experience monitoring early development and clinical pharmacology studies (Phase 0, Phase I or Phase Ib) is preferred.
• Experience in the Oncology Therapeutic Areas is required.
• Strong knowledge of the drug development process, including ICH-GCP, company SOPs, local laws and regulations is required.
• Strong computer skills in appropriate software applications and related clinical systems required.
• Must have strong written and oral communication skills.
• Must have strong leadership skills with the ability to lead initiatives.
• Willingness to travel up to 50%, approximately 2-3 days per week, with overnight stays (1-2 nights on average), is required.
• A valid Driver's License issued in one of the 50 United States and a good driving record is required.

The anticipated base pay range for this position in the San Francisco Bay Area, CA is $121,000 to $194,350. The anticipated base pay range for this position in all other U.S. locations is $105,000 to $169,050.

Johnson & Johnson is an Affirmative Action and Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, or protected veteran status and will not be discriminated against on the basis of disability.