Senior Clinical Trial Assistant

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R&D Operations
Job Sub Function:
Clinical Trial Project Management
Job Category:
Professional
All Job Posting Locations:
High Wycombe, Buckinghamshire, United Kingdom
Job Description:

Senior Clinical Trial Assistant

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 https://https://www.jnj.com/innovative-medicine

We are searching for the best talent for a Senior, Clinical Trial Assistant (Senior CTA) located High Wycombe, United Kingdom (Hybrid: 3 days per week onsite) to support the Local Trial Manager (LTM) and/or Site Manager (SM) to ensure optimal management of all documents with logistical and administrative tasks related to trial start-up, execution and closing of clinical trials.

The Senior CTA ensures trial related activities are compliant with GCO SOPs, policies and local regulatory requirements and contributes to process improvement, training and mentoring of other CTAs. The Senior, CTA contributes to central business supports and process optimization with the support of other relevant functions in line with company's requirements and business needs. Partners with Business Operations, CTA team, study teams and key stakeholders (e.g. Finance, Procurement etc.) to support routine clinical operations activities.

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

Principal Responsibilities:

• Provide administrative and logistical support to LTM and/or SM in tracking progress of the trial, management of study data, budget, organizing meetings, mailing and correspondence, materials, drug distribution and other relevant tasks as appropriate in adherence to relevant SOPs, policies and local regulatory requirements.

• Supports the local study team in performing site feasibility and/or country feasibility.

• Maintains information in relevant systems.

• Ensures current versions of the required trial documents, trial-related materials and supplies are provided to the investigational site within required timeframes, as applicable.

• Support LTM and/or SM in collecting/preparing documents required for study startup/submission to IEC/IRB and/or HA.

• Support LTM and/or SM in collecting, processing and archiving study related documents as appropriate. Use appropriate systems to ensure file completeness at designated study milestones.

• May assist LTM in conducting local investigator meeting or with making arrangements for the investigators participating in an international meeting.

• Maintains and updates contact information in relevant systems to ensure appropriate safety updates distribution.

• Comply with all training requirements

• Ensure inspection readiness at all times.

• May contribute to process improvement including, but not limited, to representing functional area in process initiatives and contribute to optimization of daily processes.

• May be assigned as a coach and mentor to a less experienced CTA.

• Contributes to central business supports and process optimization with the support of other relevant functions in line with company's requirements and business needs.

• Partners with Business Operations, CTA team, study teams and key stakeholders (e.g. Finance, Procurement etc.) to support routine clinical operations activities.

Principal Relationships:

Primary Reporting Structure: Reports to Functional Manager (FM). Primary interfaces: FM/CRM, LTM and SM(s) for assigned clinical studies, Clinical Trial Assistant team. Other Internal Interfaces: R&D Country Head, Trial Delivery Manager (TDM), LTM, SM, Compliance Managers/Specialists, Contracts & Centralized Services (CCS), Procurement, Finance, Medical Affairs. External Interfaces: Vendors, Investigators and their delegates at site.

Education and Experience Requirements:

• A minimum of a BA or BS degree in Life Sciences, Nursing or related scientific field (or equivalent experience) is required!

• Skills-set commensurate with at least 6 years relevant clinical trial experience is preferred; however, other relevant experiences and skills may be considered

• Proficient in English language.

• Strong knowledge with MS Office (Word, Excel, Access, Outlook, Explorer and PowerPoint). Strong interpersonal and negotiating skills preferred.

• Excellent organisational skills and the ability to collaborate and handle multiple priorities within a matrix environment.

• Perform activities in a timely and accurate manner.

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.

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