Clinical Trial Lead - Remote

Clinical Trial Lead - Remote 

This role is 100% remote however you must be UK based. 

The Company:

Johnson & Johnson is the world's most comprehensive and broadly-based healthcare Company, touching the lives of nearly a billion people every day. Our Family of Companies throughout the world compete in consumer, pharmaceutical and medical devices & diagnostics markets and have the skills and resources to tackle the world's most pressing health issues.
 

The Project:

This individual will be responsible for leading one or several clinical trials within the  Clinical R&D Operations CoE, as well as fostering strong, productive relationships with  colleagues across the organization. Serves as the trial leader for clinical study execution. 
 

Duties and Responsibilities:

• Serve as a Senior Clinical Trials Leader within the Clinical R&D Operations CoE operations group to execute company sponsored clinical trials for the Medical  Device Franchises
• Manage all operational activities of assigned clinical studies within the Clinical  R&D Operations group
• Serves as a member of the clinical trial/study core team and may serve as the  liaison with the Clinical R&D Franchise and Clinical R&D BSDM for projects  under his/her responsibility
• May serve as the primary contact for clinical trial sites
• Solves problems with support from Clinical Management arising during clinical  study execution, and will seek guidance for more complex problems, as needed
• Provide internal communication of important clinical data and events. Functions  as a reliable, trusted resource of accurate, up-to-date project knowledge as  requested by key stakeholders
• May be involved in other tasks to support Clinical R&D Operations and R&D  Clinical Franchise as needed
• Track assigned projects budgets to ensure adherence to business plans
• Support the implementation of new clinical systems/processes, and provide  support for publications, as needed.
• Interface and collaborate with site personnel, IRBs/ECs, Competent  Authorities/MoH, contractors/vendors, and company personnel
• Ensure personal and company compliance with all Federal, State, local and  company regulations, policies and procedures for Health, Safety, and  Environmental compliance

People Leadership Responsibilities: 

• Ensure that all Human Resource related activities, and decisions embody the Johnson  & Johnson Credo Values.
• Provide leadership within a clinical trial, ensuring that each team member has a well defined set of activities and objectives specific to their role and responsibilities within  the context of their business focus.
• Ensure efficient use of resources within the clinical study/program to provide high  quality deliverables.
   

Business Leadership Responsibilities: 

• Accountable for quality, compliance with regulations and company procedures,  timelines, and budgets for assigned clinical trials.
• May lead several small/medium clinical trials (regulated and non-regulated) and/or a  small number of large non-regulated projects that may involve other clinical  operations staff (i.e., >250K USD annual investment).
• May assist with the management of large regulated or complex trials/program under  supervision of CTM or Senior CTM.
• Identify and ensure strategies, resources, and accountabilities are in place to achieve  rapid, high quality execution of assigned clinical trials under his/her responsibilities.
• Reviews and provides feedback on clinical operation section of protocols with  supervision.
• May plan budgets for single trials with supervision
   

Functional and Technical Competencies Required:

• Requires understanding of Good Clinical Practices
• Understanding and application of regulations and standards applied in clinical  areas/regions is required.
• Good presentation skills and effectively influencing of others
• Written and oral communication skills
• Leadership in a professional and ethical manner
• Technical writing skills
   

Leadership Competencies: 

Leadership required in alignment with J&J Leadership Imperatives:  

• Connect - develop collaborative relationships with key internal and external  stakeholders, principally within allocated study teams and departments and  wherever possible across the CoE as well as the resources providers and vendors  to create a strong and productive partnership.
• Shape - Make recommendations for and actively participate in departmental  process improvement activities.
• Lead - Take ownership for development of self and engage in transparent and  constructive conversations.
• Deliver - Strive to ensure all deliverables on allocated studies and those of any  direct reports are met on time, and within budget and in compliance to SOPs and  regulations.

Education Requirements: 

• Minimum of a Bachelor’s Degree preferably in Life Science, Physical Science,  Nursing, or Biological Science required.
• BS with at least 4 years, MS with at least 3 years, PhD with at least 1 years of relevant experience preferred.
   

Other Requirements:

• Previous experience in clinical trial management or equivalent is required.
• Relevant industry certifications preferred (i.e., CCRA, RAC, CDE).
• Clinical/medical background
• Medical devices experience

In Return:

In return for this role you will receive a very competitive hourly rate. A minimum 12 month contract & an opportunity to work with a Global Leader within the Pharmaceutical sector, Johnson & Johnson. 

Please Note: This role is INSIDE IR35. Pay rate for this role will depend on how you are paid (PAYE or Umbrella options) 
 

If you are interested in this role please apply now, or for more information contact Tabitha.Crabtree@randstadsourceright.co.uk

Please Note: We are looking to get applications over by Monday morning at latest so please be quick to apply!