Associate Site Manager Early Development

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.

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.

We are searching for the best talent for an Associate Site Manager in Early Development (ED) to serve as a primary contact point between the sponsor and the investigational site (both commercial and hospital) for the conduct of early development and/or clinical pharmacology studies, working across therapeutic areas dependent upon ED&CP business needs. The head office location is in High Wycombe, Buckinghamshire, and this position is field-based.

You will have experience in Phase 1 trials, preferably within Onco/Haematology. An Associate Site Manager is assigned to trial sites ensuring inspection readiness through compliance with the clinical research protocol, company's Standard Operating Procedures (SOP), codes of Good Clinical Practice (GCP), Health Care Compliance requirements (HCC), applicable regulations and guidelines from start-up through data-base lock. Responsibilities include site assessments, pre-trial assessments, site selection, site initiation, subject recruitment and retention, monitoring and close-out. You will partner with the Clinical Trial Assistant (CTA), Trial Manager (TM) and Global Trial Leader (GTL) to ensure overall site management while performing trial related activities for assigned protocols.

You will be part of a hardworking, enthusiastic, and committed study team eager to deliver and help improve the lives of millions of patients. You will also be part of a wider local UK team that provides support and opportunities to work together to identify new and improved ways of working.

You Will Be Responsible For:

• Participating in site assessments, conducting pre-trial site assessment visits and/or participating in study feasibility assessments, providing recommendations from the local area about site/investigator selection in collaboration with the trial team.
• Acting as primary contact for assigned sites for specific ED trials and working closely with TM and trial central team regarding study progress and issue resolution.
• Attending/participating in investigator meetings as needed.
• Responsible for executing activities within site initiation and start-up, site monitoring, site management and site/study close-out per internal SOPs, other procedural documents and policies.
• Ensuring site staff have current GCP and necessary protocol, compound and systems training to conduct the clinical trial.
• Completing retraining when needed.
• Ensuring training records are filed at sites and sponsor level.
• Contributing to site level recruitment strategy and contingency planning and implementation in partnership with other functional areas to achieve clinical research targets.
• Ensuring site study supplies (such as Non-IP, lab kits, etc.) are adequate for trial conduct.
• In collaboration with Manager Site Investigational Product Specialist (SIPS) and Pharmacy Investigational Product Specialist (PIPS), ensuring that clinical drug supplies are appropriately handled, administered and stored.
• Ensuring strict adherence to investigational product preparation and administration guidelines.
• Ensuring clinical drug supplies are appropriately inventoried, accounted and returned as applicable including maintenance of accurate and complete documentation.
• Ensuring site staff complete the data entry and resolve queries within expected timelines.
• Setting up plans to improve data entry in collaboration with TM when needed and ensuring accuracy, validity and completeness of data collected at trial sites.
• Ensuring appropriate measures are in place for maintenance of the blinding when applicable.
• Ensuring that all Adverse Events (AEs)/Serious Adverse events (SAEs)/Product Quality Complaints (PQC) are reported within the required reporting timelines and documented as appropriate.
• For AEs/SAEs, ensuring that they are consistent with all data collected and with the information in the source documents.
• Maintaining complete, accurate and timely data and essential documents in systems utilized for trial management.
• Fully documenting trial related activities with respect to study monitoring.
• Writing visit reports and addressing follow-up letters to investigators within procedural timelines.
• Documenting and escalating major deviations and issues to appropriate stakeholders.
• Reviewing investigator site file for completeness and ensuring archiving retention requirements and collaborating with TM for documenting and communicating site/study progress and issues to trial central team.
• Attending regularly scheduled team meetings and trainings.
• Acting as local expert in assigned protocols.
• Developing sufficient therapeutic area and ED&CP knowledge to support roles and responsibilities.
• Working closely with TM to ensure Corrective Action Preventive Action (CAPA) is completed for QA site audits or Inspection and for quality issues identified at the site during routine monitoring and other visit types, e.g., On Site Quality Monitoring visit (OSQMV).
• Preparing trial sites for close out, conducting final close out visit.
• May be reviewing and managing site specific informed consent forms in accordance with GCO SOPs, procedural documents and applicable regulations.
• May be participating in the HA and IEC/IRB submission and notification processes as required/appropriate.
• Tracking costs at site level and ensuring payments are made, if applicable or collaborating with CCS in charge of site payments.
• Establishing and maintaining good working relationships with internal and external stakeholders, in particular investigators, trial coordinators, other site staff and key contacts in Early Development and/or Clinical Pharmacology.
• May participate in process improvement and training.

Qualifications / Requirements:

• BA/BS degree in Life Sciences, Nursing or related scientific field (or equivalent experience).
• A minimum of 2 years of clinical trial monitoring experience required.
• A minimum of 1.5 years experience in Phase 1 /Early Development trials is preferred.
• Onco/Haematology experience is preferred.
• Good knowledge of GCP, local laws, and regulations.
• Knowledge on the following systems is preferred: mCTMS, vTMF, Medidata Rave.
• Willingness to travel with occasional overnight stay away from home.
• Proficient in local language(s) and English.
• Good written and oral communication skills.
• Ability to attend High Wycombe office meetings according to business/training needs.
• Full UK driving license.

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 organization.

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.