J&J Family of Companies Clinical Registry Administrator in Titusville, New Jersey

Position summary

The Clinical Registry is responsible for posting accurate, validated and consistent information about our trials and their results on about 40 registries globally. The CR directly maintains clinicaltrials.gov and posts results on EudraCT. The CR oversees and supports all other regional or country specific registries. The CR is the center of expertise for disclosure requirements and ensures data quality and compliance requirements for all registries are met. The CR is based in BRQC Janssen, but supports all pharma, consumer and medical devices operating companies that have studies with disclosure requirements. We work closely together will clinical and medical teams, clinical development operations, regulatory affairs, biostats, programming, and local operating companies to ensure the company meets its disclosure requirements. Through collaboration with other BRQC departments and IT we ensure complete and high quality data is available for timely disclosure of all required studies. The CR team is located in the US and EU and part of the work is performed in an offshore model in India. Because of expansion of our scope and growth of the trial portfolio, we are recruiting for an additional clinical registry administrator.

The clinical registry administrator is responsible for submitting and maintaining the clinical trial information and results on various registries. The CR administrator is responsible for set-up, maintenance and closure of the workflow in our registry compliance management system. The CR administrator works with various colleagues to ensure complete and accurate data are available in source systems such as CTMS and TMS, that compliance due dates are met, and that high quality data are successfully submitted to external registries. The CR administrator will be responsible for a to be determined section of the portfolio.

Principal responsibilities

Main responsibilities will include, but are not limited to:

• Identification of studies for assessing registration requirements from source system feeds.

• Setting up studies and workflows in the registry’s compliance management tool PharmaCM

• Identify and follow-up (near) compliance events and ensure timely and complete review, approval and submission of the data is done.

• Submit and maintain registration and results records on registries

• Manage relevant section(s) of the clinical registry administrator central inbox

• Collect and follow up data quality feedback from NIH and other registry related organizations. Ensure timely resolution of raised feedback.

• Prepare overviews and metrics for management.

• Understand data landscape and customer needs for Clinical Registry

• Training of global customers and cross‐functional internal training as related to clinical registry

• Maintenance of document repositories where the compliance management system does not provide

• Participates in Clinical Registry Team projects for enhancement of processes, technologies in

use

• Data analysis as required, including support of audits and inspections where registry data are required

• Provides back-up and continuity of urgent registry operations across time zones. This includes follow up of discussions with Clinical Development Team, Operation, Regulatory or others as appropriate, posting of information to public websites in US or EU.

Works with the off-shore operations team for selected tasks.

Qualifications

Qualifications

Excellent organizational, analytical, strategic, interpersonal, written and oral skills required. Self-motivated and flexible with the ability to work effectively in a dynamic, problem-solving environment is required. Demonstrated strength in influencing and negotiation skills and ability to communicate effectively at all levels of the organization is required. Ability to perform in a team and matrix organization, as well as adapt to a dynamic environment is required. Demonstrated competencies required include industriousness, self-awareness, adaptability, attention to detail, and a high capacity for teamwork. Strong personal leadership with demonstrated competency interfacing with senior leaders, strong networking and relationship building skills is required.

• A Bachelor’s degree in Science, Business, or Computer science / technology or equivalent is required

• A minimum of 5 years of experience in a medium to large scale matrix quality organization (operational quality and/or quality assurance) or equivalent time and experience in a related R&D area (clinical trials, regulatory affairs, data management, data operations and/or statistics) is preferred.

• Demonstrated competency in accurate work with clinical trial or regulatory data, data mgt., programming, scripting or data operations

• Successful global collaborations and partnerships in a globally diverse environment

• Knowledge of procedural and records management requirements in a regulated industry is beneficial.

• Prior experience in a regulated medical industry (Pharmaceutical, Medical Devices, Consumer, CRO and/or Biotech) is required. Experience as senior/GTM CTA, Regulatory submissions coordinator or similar senior administrator roles is preferred

• Prior pharmaceutical and quality/compliance related experience is preferred

• Knowledge of the pre-clinical and clinical drug development process is beneficial

• Excellent knowledge of English is required

• Exceptional written and verbal communications skills

Required skills

Leadership experience and skills:

• Strong personal leadership with demonstrated competency interfacing with other team members

• Strong networking and relationship building skills

• Ability to support an open, inviting and creative environment

• Ability to embrace generational differences

• Experience working with multidisciplinary and cross functional leaders from IT, R&D, Medical Safety, Regulatory and Quality functions

• Strong interpersonal skills with demonstrated history of collaboration across multiple functional areas

• Proactive strategic thinker with strong problem solving skills

• Strong conflict management/negotiation skills

Technology experience and skills:

• Experience with Quality and Compliance systems is preferred

• Proficient in Microsoft Office applications

Occasional international and domestic travel required.

Location at one of the main BRQC hubs with registry presence: Titusville, Beerse, Leiden.

What’s in it for you…?

“Caring for the world, one person at a time…”

As an employee we consider you as our most valuable asset. We take your career seriously.

As part of a global team in an innovative environment your development is key and our day-to-day responsibility.

Through e-university, on the job training, various projects and programs, we ensure your personal growth.

Primary Location

Netherlands-South Holland-Leiden

Other Locations

Europe/Middle East/Africa-Belgium-Antwerp-Beerse, North America-United States-New Jersey-Titusville

Organization

Janssen-Cilag Netherlands (8345)

Job Function

Clinical Supplies

Requisition ID

1700191774W