Lead Clinical Data Analyst | J&J MedTech | Surgery

At Johnson & Johnsonwe believe health is everything. Our strength in healthcare innovation empowers us to build aworld where complex diseases are prevented treated and curedwhere treatments are smarter and less invasive andsolutions are 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 more at .

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Job Description:

Johnson & Johnson is recruiting for a Lead Clinical Data Analyst to join our MedTech Surgery business.

Purpose of the role:

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. This individual performs with little to no supervision.

What to expect:

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 work and facilitate appropriate quality review where applicable;

• Mentor peers through review of deliverables to minimize delays during the quality review process;

• Coordinate 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 launch 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

• Support strategic partnerships with Clinical System and IT leaders at the Enterprise level to ensure MD sector needs are communicated and understood and with franchise and clinical operations leaders to ensure effective implementation and utilization of systems within the Clinical R&D CoE

• Develop knowledge of therapeutic areas within the Franchises and adapt ADaM and STDM standards for medical devices for use in the MD sector; participate in industry initiatives to define/refine STDM standards

• Mentor team mates to ensure consistency in process execution and quality system execution

• Ensure upgrades and maintenance of clinical systems are delivered on time within budget and in compliance to regulations and SOPs seamlessly across all Franchises

Who are we looking for

• A Bachelors degree (or equivalent) in Statistics Computer Science or related subject area (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;

• Previous experience in Clinical Operations preferred;

• Demonstrated ability to manage a project in a team environment to deliver critical milestones;

• Strong proficiency in more than one Clinical system. Advanced certification preferred;

• Experience with CDISC STDM preferred;

• Excellent verbal and written communication skills;

• Knowledge of GCP and SDLC

• Support strategic partnerships with Clinical System and IT leaders at the Enterprise level to ensure MD sector needs are communicated and understood and with franchise and clinical operations leaders to ensure effective implementation and utilization of systems within the Clinical R&D CoE

• Develop knowledge of therapeutic areas within the Franchises and adapt ADaM and STDM standards for medical devices for use in the MD sector; participate in industry initiatives to define/refine STDM standard

• Mentor team mates to ensure consistency in process execution and quality system execution

• Ensure upgrades and maintenance of clinical systems are delivered on time within budget and in compliance to regulations and SOPs seamlessly across all Franchises

What type of mark will YOU make

By joining Johnson & Johnson MedTech you will find boundless opportunities to craft your path & amplify your impact inside & outside our walls. And with our commitment to be the worlds healthiest workforce you can strengthen your body as well and your mind. When you work at Johnson & Johnson you can touch over a Billion lives worldwide every day. And when you apply your talent to our collective purpose theres no end to the lasting impact we can make together. And that changes everything.

Whats in it for YOU

Its important to us that you feel you can bring your whole self to work; at Johnson & Johnson we provide an environment for you to fulfil your career aspirations as well as promoting your physical and mental wellbeing. As part of our offering you will receive a competitive compensation and benefits package as well as benefits that can be tailored to what is valuable to you throughout different stages of your life. Examples of this include online Digital GP private healthcare Retail Vouchers Discounted & Subsidised Gym memberships and you can get to support community projects as part of our global Corporate Social Responsibility programme.

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