Senior Clinical Data Analyst - 2406185694W

Description

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. Learn more at https://www.jnj.com/.

Biosense Webster, Inc is recruiting for a Senior Clinical Data Analyst, to be based at anywhere is united states.

Biosense Webster, Inc. is the global leader in the science of diagnosing and treating heart rhythm disorders. The company established its leadership in electrophysiology with the development of the first real-time, 3D cardiac mapping and navigation technology, as well as the first electrophysiology catheter. The introduction of the company’s CARTO® 3 System in 2009 revolutionized 3D mapping technology by increasing the accuracy, speed, and efficiency of the cardiac ablation procedure.

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.

POSITION DUTIES & 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 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, 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;

Qualifications

• A Bachelor’s degree (or equivalent) in Statistics , Computer Science or related discipline (required),

• Minimum of 4 years of system support in clinical research

• experience within Medical Device or Pharmaceuticals is preferred

• Strong proficiency with the Medidata Rave EDC required, proficiency in custom functions and tSDV plan development preferred;

• Knowledge of CTMS and eTMF is preferred;

• 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;

This job posting is anticipated to close on 6/15/2024. The Company may however extend this time-period, in which case the posting will remain available on https://www.careers.jnj.com to accept additional applications.

The anticipated base salary for this position is $88,000 to $123,000

Johnson & Johnson is an Affirmative Action and 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, or protected veteran status and will not be discriminated against on the basis of disability.

For more information on how we support the whole health of our employees throughout their wellness, career and life journey, please visit www.careers.jnj.com .

Primary Location NA-United States

Organization Biosense Webster Inc. (6010)

Job Function Clinical Data Management

Req ID: 2406185694W