Johnson & Johnson Careers
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Data Processing Solution Manager, Platform Lead
Requisition ID: 1805621083W
The DPS Manager, Platform Lead provides leadership in clinical data processing technologies to guarantee support required by the IDAR organization, with a focus on platforms related to clinical data processing and data delivery. 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 (mainly IDAR).
Furthermore she/he will expand the service by looking out for, defining, proposing and implementing innovative services within her/his area.
She/he functionally manages and develops a team of Domain Experts to deliver excellent services and ensure their personal growth. The jobholder oversees projects resource planning taking into account personal development opportunities for team members. 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, keeps specific area leaders informed of decisions. She/he interacts with Data Delivery clinical teams and clinical software and solutions providers. Lastly, she/he provides direction to external vendors and contractors and may manage and/or coach experts within the team as well.
She/he will have a proven ability to lead, manage and develop a high-performing team to efficiently support advanced services and initiatives. She/he will have significant experience gained through working with diverse and complex business processes and associated systems infrastructures.
The jobholder manages all aspects of human resources for the team, including development, staffing, and talent management; will act as the 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.
She/he lead will work with stakeholders in the business departments to determine the service needs, develop and maintain metrics to measure service delivery. Oversee vendor relationships, implementation, and integration for domain. The service platform includes but may not be limited to: SAS Drug Development hosted environment for Clinical data repositories and SAS programming, used by both internal departments and CRO suppliers; customized solutions to automate clinical data management activities like clinical standards library management, clinical study specification setup and clinical data and analysis validation; and conversion tooling to translate electronically captured data into datasets for regulatory submissions and for analysis.
She/he installs and develops a continuous improvement and innovation culture, lead process improvement initiatives; challenge and reassess departmental processes in relation to internal and external changes; consults with Process Improvement groups and Shared Solutions teams to define and execute initiatives to improve the service delivery; and delivers and continuously improves a harmonized approach to system validation and level 1/2/3 support across the platform and in line with the EBIS shared services approach.
She/he ensures compliance and support for audit and inspections as appropriate. This individual will also ensure compliance with regulatory, security and other audit requirements at all times. He/she will manage the compliance plans and ensure adherence for services under responsibility.
A minimum of a Bachelor’s degree in Engineering, Science, Computer Science or related discipline is required.
A Master’s degree is preferred.
A minimum 8 years of experience relevant experience in clinical development in the Pharma, Biotech or CRO sector is required. The candidate should have a minimum 3 years of people management experience with a proven record in developing talent. She/he should also possess broad experience leading and direct matrix teams. The candidate must have experience in managing vendor relationships.
This position requires well-established knowledge of human resources and people development processes and practices. The candidate should have thorough functional management leadership experience, including making decisions and solving challenging issues.
Ideally the candidate should possess a working knowledge in systems used in clinical trials, specifically in Data Management and Statistical Programming.
This position will require the ability to think analytically, be quality results oriented and customer focused. This individual must have a global business mindset, possess strong project leadership capabilities, be solutions oriented, provide process enhancements, with operational excellence. This role will also require building strong internal and external partnerships and excellent communication skills.
The DPS Manager, Platform Lead requires good understanding of GCP, ICH, and 21 CFR Part 11.
The position also requires experience prioritizing and managing multiple tasks across a team and demonstrated written and verbal communication skills.
Janssen Pharmaceutica N.V. (7555)
Clinical Data Management