The Senior Clinical Registry Coordinator 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 Senior Clinical Registry Coordinator:
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.
Independently advises company teams with regards to registry compliance and registry-related questions.
Leads or supports BRQC Janssen and cross-pharma/cross-segment initiatives, meetings, etc. as assigned by the BRQC Janssen leadership.
Will make decisions regarding business issues, strategic support, and organizational development, as required by business urgency and organizational growth. The scope is across various functions, segments and specifically BRQC Janssen, and requires collaboration, alignment, and influencing.
Is expected to lead and be proactive in setting priorities to achieve BRQC registry goals and objectives.
Must be able to effectively operate in a matrix environment and influence and interact with senior enterprise leaders and functional leaders on a regular basis. The ability to combine business needs with functional objectives is required.
Knowledge, Education, and Experience
At minimum a bachelor’s degree in Science, Business, Computer Science or Technology or equivalent
Experience for Clinical Registry Coordinator, Senior Specialist
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.
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 to adapt to a dynamic environment.
Ability to lead and support project teams and responsible for the balance of priorities
Strong networking and relationship-building skills
Experience in working with multidisciplinary and cross-functional leaders from IT, R&D, Medical Safety, Regulatory and Quality functions.
Successful global collaborations and partnerships in a globally diverse environment.
Willingly to take the lead in working with complex technology/information solutions
Demonstrated competencies required include industriousness, self-awareness, adaptability, attention to detail, change management, stakeholder management, and a high capacity for teamwork.
Strong personal leadership with demonstrated competency interfacing with senior leaders, strong networking and relationship-building skills, and a proven track record of leading and developing people.
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 require the resolution of complex problems within tight timelines.
Occasional international and/or domestic travel can be required
Netherlands-South Holland-Leiden- Organization
Janssen Biologics (7266) Job Function
R&D Requisition ID
Open Positions from Johnson & Johnson Family of Companies