The Clinical Registry Specialist is a member of the enterprise wide Clinical Registry team and can support J&J pharma, consumer and/or medical devices operating companies with their clinical trial data disclosure obligations. The team, located in the US, Europe and Asia (third party), is responsible for ensuring that accurate, validated and consistent clinical trial data is posted on clinical trial registries worldwide.
The Clinical Registry Specialist:
•Is part of the Bioresearch Quality & Compliance (BRQC) Quality Analytics team.
•Oversees and supports regional and/or local registries for a determined section of the Johnson & Johnson portfolio.
•Is Subject Matter Expert with regards to clinical trial disclosure requirements.
•Ensures that data quality and compliance requirements for all registries in her/his portfolio are met.
•Works closely together will clinical and medical teams, clinical development operations, regulatory affairs, biostats & programming, and/or local operating companies to ensure that the company meets its disclosure requirements and that the data to be disclosed is consistent across the registries and is of high quality and integrity.
•Monitors compliance of registration and results disclosures.
•Works with vendors to ensure that patients can be referred from registries to participating trial sites, as assigned.
•Keeps oversight of intelligence on disclosure requirements worldwide, as assigned.
•Advises company teams with regards to registry compliance and registry-related questions.
•Supports BRQC Janssen and cross-pharma/cross-segment initiatives, meetings etc. as assigned by the BRQC Janssen leadership.
Knowledge, Education and Experience
At minimum a bachelor’s degree in Science, Business, Computer Science or Technology or equivalent
A minimum of 3 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.
-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.
-Experience in pharmaceutical regulations and R&D processes is a plus.
-Awareness of disclosure legislation is a plus.
-Demonstrated competency in accurate work with clinical trial or regulatory data, data management, programming, scripting or data operations.
-Excellent communication skills both orally and in writing with the ability to communicate effectively at all levels of the organization.
-Strong interpersonal skills with the ability to support an open, inviting and creative environment.
-Strong conflict management skills.
-Demonstrated strength in influencing and negotiation skills.
-Excellent knowledge of English is required. Knowledge of an additional language is a plus.
-Decision making & Problem-solving Pro-active strategic thinker with excellent analytical, problem solving and decision-making skills.
-Strong planning, organizational, and project management skills
-Self-motivated and flexible with the ability to work effectively in a dynamic, problem-solving environment.
-Leadership & collaboration Ability to perform in a team and matrix organization, as well as adapt to a dynamic environment.
-Ability to lead and support project teams and responsible for balance of priorities
-Strong networking and relationship building skills
Technical knowledge Knowledge of procedural and records management requirements in a regulated industry is beneficial.
Knowledge of the pre-clinical and clinical drug development process is beneficial.
Proficient in Microsoft Office applications.
Experience with Quality and Compliance systems is preferred.
Working conditions Working conditions require resolution of complex problems within tight timelines.
Occasional international and/or domestic travel can be required
Janssen-Cilag Netherlands (8345)