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J&J Family of Companies Associate Director, Data Processing Solutions in Beerse, Belgium

Position Summary

The Associate Director Data Processing Solutions provides leadership in clinical data processing technologies to guarantee support required by the Integrated Data Analytics and Reporting (IDAR) and Quantitative Sciences (QS) organizations. She/he will oversee, organize and continuously improve the daily operations, user facing activities and vendor management to deliver a consistent service toward the supported departments. Furthermore she/he will expand the service by looking out for, defining, proposing and implementing innovative services within her/his area.

The Associate Director functionally manages and develops a team of domain experts to deliver excellent services and ensure their personal growth. She/he oversees projects resource planning, taking into account personal development opportunities for team members, and is responsible for all aspects of human resources for the team

She/he works with stakeholders in various departments (e.g. IT, QS, IDAR) to build and maintain relationships, determine service needs, develop and maintain metrics to measure service delivery and oversees vendor relationships, and systems/projects’ implementation. She/he impacts processes, project timelines, priorities and functionality of conducting clinical trials and clinical trial software by defining and leading innovation projects. She/he analyzes and provides strategy to recommend decisions and keeps specific area leaders informed of decisions. She/he interacts with IDAR and QS teams, biostatisticians, medical writing and clinical software and solutions providers. She/he provides direction to external vendors and contractors.

The Associate Director Data Processing Solutions will have a proven ability to lead, manage and develop a high-performing team to efficiently support advanced systems, processes and initiatives.

The following solutions are part of the portfolio:

•Data Management Environment (DME) platform and/or Statistical Programming Environment (SCE) platform and support processes;

•SAAS based solutions tailored to the life sciences industry;

•Customized web platforms to automate clinical data management activities like clinical standards library management, clinical study specification setup and clinical data validation;

•Conversion tooling to translate electronically captured data into datasets for regulatory submissions and for analysis and for consumption by various downstream applications

Principal Responsibilities

•Manage team of domain and technical experts

•Responsible for all aspects of human resources for the team. including development, staffing, and talent management

•Oversee projects, budgets, and resource planning, taking into account personal development opportunities for team members

•Act as functional manager of the domain experts within the team, assign individuals to projects based on their expertise, availability and development opportunities and ensure development plans are in place for all team members

•Collaborate with stakeholders in various departments (e.g. IT, QS, IDAR, EBIS) to build and maintain strategic relationships, determine service needs and define strategies to meet business needs

•Build and maintain external relationships with industry peers and scientific community

•Oversee and provide direction to external vendors and contractors

•Lead process improvement initiatives and strategic projects

•Maintain technical ownership of a strategic platform(s)

•Provide technical lead to the deployment of new solutions

•Identify, participate and lead process, system, and tool improvement initiatives

•Assume responsibilities to inspire and develop a continuous improvement and innovation culture with respect to the current and future data processing solutions

•Deliver and continuously improve a harmonized approach to system validation and level 1/2/3 support across Global Development (GD) organization for internal and external systems.

•Ensure compliance with regulatory agencies and Janssen policies and regulations, and develop required documentation

•Manage the compliance plans and ensure adherence for services under responsibility

•Provide support for audits and inspections

Qualifications

Education and Experience Requirements

•A minimum of a Bachelor’s degree in Engineering, Science, Computer Science or related discipline is required. A Master’s degree is strongly preferred.

• A minimum of 10 years of experience working within systems covering clinical development in the Pharma/Biotech/CRO sector is required

•Strong and extensive experience managing teams or leading matrix teams at management level

•Experience in people management with a proven track record in developing talent

•Well-established knowledge of human resources and people development processes and practices

•Functional management leadership experience, including making decisions and solving challenging issues

•Strong knowledge and thorough understanding of multiple cross-functional eClinical systems, industry trends, industry standards, guidelines and regulations, and best practices, including GCP, ICH, and 21 CFR Part 11.

•Experience in prioritizing and managing multiple tasks across a team and demonstrated excellent written and verbal communication skills

•Extensive experience in managing vendor relationships

•Experience, with a proven track record, in delivering transformational system implementations

•Relevant technical/system experience with SAS or SAS-based systems in a clinical research setting

•Proven ability to lead, manage and develop a high-performing team to efficiently support advanced systems, processes and initiatives

•Proven record of building cross-functional and cross-departmental relationships

Other

•This role will require building strong internal and external partnerships in a global setting

•A successful individual must possess excellent communication skills in English

• Position will require 20% travel domestic and international

Primary Location

Belgium-Antwerp-Beerse-

Organization

Janssen Pharmaceutica N.V. (7555)

Job Function

R&D

Requisition ID

2005809734W

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