Lead Clinical Data Analyst

This job is with Johnson & Johnson, an inclusive employer. 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.

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). Fueled by innovation at the intersection of biology and technology, we're developing the next generation of smarter, less invasive, more personalized treatments. Our Orthopedics teams help keep more than 6 million people moving each year while delivering clinical and economic value to surgeons and healthcare systems.

Your unique talents will help patients on their journey to wellness. 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.

You will:

• Collaborate with Data Management leadership 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 and Franchise to develop project management plans for trial execution including timelines and milestones for study-specific systems set-up, UAT, maintenance and closeout as required.
• 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 where applicable.
• Mentor peers through review of deliverables to minimize delays during the quality review process.
• Interface between Clinical R&D, IT and Quality regarding clinical systems, UAT, processes and other tools.
• Facilitate support requests associated with clinical systems.
• 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, UAT and ongoing maintenance.
• Represent the Medical Devices Sector on Enterprise or cross-sector Clinical System teams.
• Assist with the implementation of study metrics.
• Analyse complex change requests to determine feasibility for incorporation within clinical studies.
• Evaluate vendor supplied release documentation for implementation feasibility and collaborate with appropriate partners to define project parameters.
• Responsible for communicating business related issues or opportunities to next management level.
• Responsible for ensuring personal and Company compliance with all Federal, State, local and Company regulations, policies, and procedures.
• Perform other duties assigned as needed.

Qualifications:

• A Bachelor's degree (or equivalent) in Statistics, Computer Science or related discipline (required), with 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; Strong proficiency in more than one Clinical system preferred.
• Demonstrated ability to manage a project in a team environment to deliver critical milestones required.
• Must have proven experience with Medidata or Veeva systems.
• Excellent verbal and written communication skills required.
• Previous experience in Clinical Operations preferred.
• Experience with CDISC STDM preferred.
• Knowledge of GCP and SDLC 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.