Lead Clinical Data Analyst

Johnson & Johnson Innovative Medicine•Ohio, IN

3d•$109,000 - $174,800

About The Position

We are searching for the best talent for a Lead Clinical Data Analyst to join our DePuy Synthes team located in Warsaw, IN; Raynham, MA; West Chester, PA; 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. Are you passionate about improving and expanding the possibilities of Orthopedics? Ready to join a team that’s reimagining how we heal? Our Orthopedics teams help keep more than 6 million people moving each year while delivering clinical and economic value to surgeons and healthcare systems. Our teams build solutions for joint reconstruction; trauma and craniomaxillofacial; sports, extremities, and elective foot and ankle; spine; and robotics and digital surgery. Your unique talents will help patients on their journey to wellness. Learn more at https://www.jnj.com/medtech Johnson & Johnson announced plans to separate our Orthopaedics business to establish a standalone Orthopaedics company, operating as DePuy Synthes. The process of the planned separation is anticipated to be completed within 18 to 24 months, subject to legal requirements, including consultation with works councils and other employee representative bodies, as may be required, regulatory approvals and other customary conditions and approvals. Should you accept this position, it is anticipated that, following conclusion of the transaction, you would be an employee of DePuy Synthes and your employment would be governed by DePuy Synthes employment processes, programs, policies, and benefit plans. In that case, details of any planned changes would be provided to you by DePuy Synthes at an appropriate time and subject to any necessary consultation processes.

Requirements

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.
Advanced certification 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

Nice To Haves

Previous experience in Clinical Operations preferred
Experience with CDISC STDM preferred
Knowledge of GCP and SDLC preferred

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; Assist with vendor evaluation and selection activities for clinical 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 (as assigned)
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 including CSV regarding clinical systems, UAT, processes and other tools
Facilitate support requests associated with clinical systems (as needed)
Serve as first line of contact from study initiation through go live for each clinical study. Systems may include: CTMS, eTMF, IxRS, EDCs
Facilitate the development of training materials and programs related to system set-up, UAT and ongoing maintenance as well as other relevant processes
Represent the Medical Devices Sector on Enterprise or cross-sector Clinical System teams (as needed)
Assist with the implementation of study metrics
Analyzes complex change requests to determine feasibility for incorporation within clinical studies
Evaluates 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
Performs other duties assigned as needed