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 jnj.com.
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.
**Job Function: **
R&D Operations
**Job Sub Function: **
Clinical Trial Support
Job Category:
Professional
All Job Posting Locations:
High Wycombe, Buckinghamshire, United Kingdom
Job Description:
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. Our Oncology team is focused on the elimination of cancer by discovering new pathways and modalities to finding treatments and cures. We lead where medicine is going and need innovators with an unwavering commitment to results. 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 https://www.jnj.com/innovative-medicine.
We are searching for the best talent for an Associate, Site Manager (SM) who will serve as the primary contact point between the Sponsor and Investigational Sites. The Associate SM is assigned to trial sites to ensure inspection readiness through compliance with the clinical trial protocol, company Standard Operating Procedures (SOP), Good Clinical Practice (GCP), and applicable regulations and guidelines from study start-up through to site closure. Responsibilities may include assisting with site selection, site qualification assessment, subject recruitment and retention planning, site initiation, on-site and remote monitoring and close-out activities. The Associate, Site Manager will partner with the Local Trial Manager (LTM), Clinical Trial Assistant (CTA) and Trial Delivery Manager (TDM) to ensure overall site management while performing trial related activities for assigned protocols.
You need a flexible mindset and have the ability to work in a constantly evolving environment. You will be part of a hardworking, enthusiastic, and committed team eager to deliver and helping to improve the lives of millions of patients.
Are you ready to join our team? Then please read further!
You will be responsible for:
Acting as primary local company contact for assigned sites for specific trials.
- May participate in site feasibility and/or site qualification visits
- Responsible for delivering 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.
- Contributes to site level recruitment strategy and contingency planning and implementation, in partnership with other functional areas.
- Ensures accuracy, validity and completeness of data collected at trial sites.
- Ensures that all Adverse Events (AE) /Serious Adverse Events (SAEs)/Product Quality Complaints (PQCs) are reported within the required reporting timelines and documented as appropriate.
- Prepares trial sites for close out, conducts final close out visit.
- Tracks costs at site level and ensure payments are made, if applicable.
- Establishes and maintains strong working relationships with internal and external partners, in particular investigators, trial coordinators and other site staff.
Qualifications and Experience Required:
- A minimum of a BA or BS degree in Life Sciences, Nursing or related scientific field (or equivalent experience) is required.
- Clinical trial monitoring experience is preferred, however, other relevant experiences and skills may be considered by the hiring manager when considering the candidate’s eligibility.
- Oncology therapeutic area experience preferred (but not essential).
- Understanding of the drug development process including GCP and local regulatory requirements.
- Ability to work on multiple trials in parallel, if required.
- Proficient in speaking and writing the English language.
- Strong team member and self-starter with the ability to work independently
- Strong communication and influencing skills to effectively manage study sites both remotely and face-to-face
- Willingness to travel up to 50% (up to 2-3 days per week) with some overnight stays as necessary
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 crucial job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation.
**Required Skills: **
Clinical Trials Monitoring, Extensive Traveling, Good Clinical Practice (GCP)
Preferred Skills:
Analytical Reasoning, Business Behavior, Business English, Clinical Data Management, Clinical Trials, Clinical Trials Operations, Execution Focus, Issue Escalation, Laboratory Operations, Oncology, Process Improvements, Process Oriented, Project Support, Regulatory Environment, Research and Development, Research Ethics, Study Management, Time Management