Site Manager, Early Development & Clinical Pharmacology
Site Manager, Early Development & Clinical Pharmacology
We are looking for a Site Manager in Early Development & Clinical Pharmacology (ED&CP) 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. The head office location is in High Wycombe, Buckinghamshire, and this position is home-based. Preferably you will have experience in Phase 1 Haematology but other therapeutic areas are considered. A 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.
- 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.
- 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.
- Ensures site staff have current GCP and necessary protocol, compound and systems training to conduct the clinical trial. Complete retraining when needed. Ensure training records are filed at sites and sponsor level.
- Contributes to site level recruitment strategy and contingency planning and implementation in partnership with other functional areas to achieve clinical research target.
- Ensures site study supplies (such as Non-IP, lab kits, etc.) are adequate for trial conduct.
- In collaboration with Site Investigational Product Specialist (SIPS) and Pharmacy Investigational Product Specialist (PIPS), ensures that clinical drug supplies are appropriately handled, administered and stored. Ensure strict adherence to investigational product preparation and administration guidelines. Ensures clinical drug supplies are appropriately inventoried, accounted and returned as applicable including maintenance of accurate and complete documentation.
- Ensures full documentation of trial related activities in all study files; communicates site and study progress and issues to the Local Trials manager and central study teams.
- Tracks costs at site level and ensure payments are made, if applicable or collaborates with C&G in charge of site payments.
- Establishes and maintains 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 to process improvement and training.
Education and Experience Requirements:
- BA/BS degree in Life Sciences, Nursing or related scientific field (or equivalent experience)
- A minimum of 1 years of clinical trial monitoring experience in is preferred, however, other relevant working experiences and skills may be considered by the hiring manager.
- A minimum of 1.5 years experience in Phase 1 trials is preferred
- Phase 1 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
- Full UK driving license
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. We are Janssen!
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.
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.