Yacht Life Sciences has a vacancy for a Senior Clinical Registry Coordinator to work for Janssen Biologics.
As a Senior Clinical Registry Coordinator you are 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:
- 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. These teams can, in part of in whole, be outsourced or with co-development partners.
- Ensures agreement with clinical and medical teams on the disclosure strategy and monitors compliance of protocol registrations and results disclosures.
- Coordinates and ensures timely delivery of disclosure data and documents with external service providers and business partners
- Keeps oversight of intelligence on disclosure requirements worldwide, as assigned. Maintains intelligence and disclosure agreements for assigned registries.
- Works with external service providers to ensure that patients can be referred from registries to participating trial sites, as assigned.
- Independently advises company teams with regards to registry compliance and registry-related questions.
- Will make decisions regarding business issues and strategic support as required by business urgency. The scope is across various functions and segments, and requires collaboration, alignment, and influencing.
- Is expected to lead and be proactive in setting priorities to achieve 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
- At minimum a Bachelor’s degree in Biomedical Science, Business, Computer Science or Technology or equivalent (by relevant working experience)
- > 5 years of similar 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)
- Prior experience in a regulated medical industry (Pharmaceutical, Medical Devices, Consumer, CRO and/or Biotech)
- Experience as senior/GTM CTA, Regulatory submissions coordinator or similar senior administrator roles
- Prior pharmaceutical and quality/compliance related experience
- Experience in pharmaceutical regulations and R&D processes
- Awareness of disclosure legislation
- Demonstrated competency in accurate work with clinical trial or regulatory data, data management, programming, scripting or data operations.
- Excellent knowledge of English is required. Knowledge of an additional language is a plus
- 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.
- 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.
- 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
- 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.
Terms of employment:
This concerns a secondment contract via Yacht until December 2023, with possibility to extend. Full-time (40h) is strongly preferred, working 32 or 36 hours per week can be discussed. We will offer a competitive benefits package in line with your seniority and the seniority of the position.
This position is open for freelance/ ZZP as well.
About the company:
Janssen Biologics, part of J&J, is a global biotechnological company that develops, acquires, and commercializes pharmaceutical products and biopharmaceutical therapies.
Janssen Biologics B.V. is one of the Janssen Pharmaceutical Companies of Johnson & Johnson, and is focused on the development, production and marketing of vaccines and antibodies to prevent and combat infectious diseases. At the Leiden Site, talented and multi-scaled people are working in a dynamic culture in which innovation and a 'can do' state of mind are the central points.
Inclusiviteit en diversiteit
Uiteraard staat deze vacature open voor iedereen die zich hierin herkent. We geloven dat diverse teams van belang zijn voor ons als lerende organisatie, die voorop wil blijven lopen in de wereld van werk. Want juist verschillen tussen mensen zorgen voor groei. Van collega's, klanten, kandidaten en daarmee van Yacht. Heb jij een uniek talent? We ontmoeten je graag.