About Johnson & Johnson
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.

Role Overview
We are searching for the best talent for a Lead Clinical Data Analyst to join our DePuy Synthes team located in Leeds, West Yorkshire (UK). Responsibilities include coordination of timelines and resources required to implement and maintain a variety of clinical systems as well as provide oversight and coordination of all aspects of the development and management of clinical study databases across a variety of platforms. Coordination of activities will require the development of strong, productive relationships with colleagues across the MD sector.

Key Responsibilities

• Collaborate with Data Management leadership (including Programming and Biostatistics) to define and document data and process standards
• Provide in-house project support for creation, routing and approval of all system deliverables associated with clinical systems
• Support the development and maintenance of global harmonized processes and procedures for system support
• Support vendor evaluation, selection, contracting, and oversight activities for outsourced systems
• Work with BSDM partners and leadership in Clinical Operations to develop project management plans for trial execution including timelines and milestones for study-specific systems set-up, UAT, maintenance and closeout
• Lead project management activity related to the deployment of Interactive Voice/Web Response Systems (IxRS), Electronic Data Capture (EDC) Systems, CTMS, eTMF and other relevant platforms
• Create, review and facilitate approval of system deliverables and facilitate appropriate quality review
• Mentor peers through review of deliverables to minimize delays during the quality review process
• Interface between Clinical R&D, IT and Quality including CSV regarding clinical systems, UAT, processes and other tools
• Serve as first line of contact from study initiation through go live for each clinical study
• Facilitate the development of training materials and programs related to system set-up and UAT
• Assist with the implementation of study metrics and analyze complex change requests

Qualifications

• A Bachelor’s degree (or equivalent) in Statistics, Computer Science or related discipline (required)
• At least 6 years of system support in clinical research within Medical Device or Pharmaceuticals
• Experience with at least one clinical system (EDC, CTMS, eTMF and IxRS) is required; proficiency in multiple systems preferred
• Demonstrated ability to manage a project in a team environment to deliver critical milestones
• Proven experience with Medidata or Veeva systems
• Knowledge of GCP and SDLC preferred
• Experience with CDISC STDM preferred
• Travel up to 10%

Johnson & Johnson is an 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, disability, protected veteran status or other characteristics protected by federal, state or local law.