Senior Site Manager, Early Development

At Johnson & Johnsonwe believe health is everything. Our strength in healthcare innovation empowers us to build aworld where complex diseases are prevented treated and curedwhere treatments are smarter and less invasive andsolutions are 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 more at .

As guided by Our Credo Johnson & Johnson is responsible to our employees who work with us throughout the world. We provide an inclusive work environment where each person is considered as an individual. At Johnson & Johnson we respect the diversity and dignity of our employees and recognize their merit.

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About Innovative Medicine

Our expertise in Innovative Medicine is informed and inspired by patients whose insights fuel our science-based advancements. Visionaries like you work on teams that save lives by developing the medicines of tomorrow. Join us in developing treatments finding cures and pioneering the path from lab to life while championing patients every step of the way. Learn more at are searching for the best talent for a Senior Site Manager Early Development with our Global Clinical Operations (GCO) business to 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) other organisations the Site Manager may be known as Clinical Research Associate or Monitor. The head office location is in High Wycombe Buckinghamshire and this position is home-based with monthly in-office requirement United Kingdom.

Purpose

As a Senior Site Manager Early Development you are assigned to trial sites ensuring inspection readiness through compliance with the clinical research protocol companys Standard Operating Procedures (SOP) codes of Good Clinical Practice (GCP) Healthcare compliance (HCC) requirements applicable regulations and guidelines from start-up through data-base lock. Responsibilities include site assessments pretrial assessments site selection site initiation subject recruitment and retention monitoring and close-out. Partners 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. You may contribute to process improvement training and mentoring of other Site Managers.

Are you ready to join our team Then please read further!

Principal Responsibilities:

• Participates in site assessments conducts pre-trial site assessment visits and/or participates to study feasibility assessments providing recommendation from local area about site/investigator selection in collaboration with the trial team.
• Acts as primary contact for assigned sites for specific ED&CP trials and works closely with TM and trial central team regarding study progress and issue resolution.
• Attends/participates in investigator meetings as needed.
• Execute endtoend site activities across startup initiation monitoring management and closeout in line with internal SOPs including implementation of riskbased monitoring approaches and use of study systems and dashboards.
• Ensure sites are inspectionready with appropriate GCP protocol system and compound training in place accurate documentation maintained and corrective actions implemented where required.
• Oversee data quality and timeliness at site level including query resolution maintenance of the blind (where applicable) and accurate complete documentation in trial management systems.
• Ensure timely and compliant reporting and documentation of adverse events serious adverse events and product quality complaints.
• Support sitelevel recruitment planning contingency actions and supply management including oversight of nonIP materials and collaboration with pharmacy and investigational product specialists to ensure appropriate handling accountability and storage of clinical supplies.
• Prepare conduct and document monitoring quality and closeout visits including followup escalation of significant issues and contribution to CAPA activities arising from audits or inspections.
• Collaborate with internal stakeholders to communicate site and study status track site costs and payments where applicable and support submissions amendments and consent management as required.
• Build and maintain strong working relationships with investigators site staff and internal partners contributing to sitelevel lessons learned and acting as a subject matter expert in site management practices.
• Participate in team meetings training process improvement activities and special initiatives and provide coaching or mentoring to less experienced colleagues when assigned.

Principal Relationships:

The role reports to the FM and works closely with FM CTAs SMs TMs PIPS SIPS SSLs the Compliance Manager/Specialist and the Local Safety Officer. It also interfaces with a range of internal stakeholders including Contract and Compliance Services TDM/TDL Therapeutic Area study teams (such as Study Responsible Scientists and/or Physicians) Integrated Data Analytics and Reporting Bioresearch Quality and Compliance and ED&CP Business Operations & Quality as required. Externally the role interacts with investigational site staff and other partners as needed.

Education and Experience Requirements:

A minimum of a BA or BS degree in Life Sciences (or equivalent experience) is required.

A minimum of 3 years of clinical trial monitoring experience is preferred; however other relevant experiences and skills may be considered by the hiring manager when considering the candidates eligibility. Experience in monitoring ED&CP studies is preferred!

Strong knowledge of ICH-GCP company standard operating procedures local laws and regulations assigned protocols and associated protocol specific procedures including monitoring guidelines.

Strong IT skills in appropriate software and company systems.

Willingness to travel with occasional/regular overnight stay away from home depending on the region.

Good English written and oral communication skills.

Flexible mindset and ability to work at a fast pace within small exploratory international study teams in a fast-changing environment.

Ability to work on multiple trials in parallel in different disease areas.

Benefits:

We offer a competitive salary and extensive benefits package. The health and well-being of our employees is a priority we have a flexible working environment as we value work-life balance. We offer career development opportunities for those who want to grow and be part of our organisation.

Johnson & Johnson Family of Companies are equal opportunity employers and all qualified applicants will be considered for employment without regard to any other characteristic protected by law.

We will ensure that individuals with disabilities are provided a reasonable accommodation to participate in the job application or interview process to perform important job functions and to receive other benefits and privileges of employment. Please contact us to request accommodation.

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