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- Tasks: Lead innovative strategies in clinical data standards and collaborate with diverse teams.
- Company: Join Johnson & Johnson, a leader in healthcare innovation and inclusivity.
- Benefits: Enjoy competitive salary, flexible work environment, and career development opportunities.
- Other info: Hybrid role with excellent growth potential in a dynamic environment.
- Why this job: Make a real impact on health by developing the medicines of tomorrow.
- Qualifications: Bachelor's degree in a relevant field and 6+ years of experience required.
The predicted salary is between 60000 - 75000 £ per year.
This job is with Johnson & Johnson, an inclusive employer and a member of myGwork – the largest global platform for the LGBTQ+ business community.
At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity.
As guided by Our Credo, Johnson & Johnson is responsible to our employees who work with us throughout the world. We provide an inclusive work environment where each person is considered as an individual. At Johnson & Johnson, we respect the diversity and dignity of our employees and recognize their merit.
Job Function: Data Analytics Computational Sciences
Job Sub Function: Clinical Data Management
Job Category: Professional
All Job Posting Locations: High Wycombe, Buckinghamshire, United Kingdom
About Innovative Medicine:
Our expertise in Innovative Medicine is informed and inspired by patients, whose insights fuel our science-based advancements. Visionaries like you work on teams that save lives by developing the medicines of tomorrow.
Join us in developing treatments, finding cures, and pioneering the path from lab to life while championing patients every step of the way.
We are searching for the best talent for a Manager, Standards Management Expert (ADaM) within Integrated Data Analytics Reporting (IDAR), to provide expert guidance and tailored solutions on projects, programs, and processes that span multiple related areas in support of the organisations overall Clinical Data Standards strategy. The Standards Management Expert (ADaM) is an individual contributor who takes a leadership role in the collaboration with various internal and external partners to ensure consistency of clinical data standards across clinical trials and in compliance with regulatory requirements.
This role may be located in High Wycombe, United Kingdom, Beerse, Belgium or Leiden, Netherlands (Hybrid / 3 days onsite per week preferred).
Purpose:
- Acts as a top-level specialist to establish programs and innovative strategies that advance the Clinical Data Standards organization.
- Manages standards, projects, programs, or processes for Clinical Data Standards in line with agreed internal strategy and regulatory requirements.
- Participates in the development of solutions to provide accurate, timely, and consistent clinical data standards to study teams.
- Communicates ideas for process improvement, while supporting the design and integration of new technologies to enhance clinical data standards.
- Coaches and trains junior colleagues in clinical data standards application and responsibilities.
- Integrates Johnson & Johnson's Credo and Leadership Imperatives into team goals and decision making.
You will be responsible for:
Manager, Standards Management Expert (ADaM) is responsible for the development and maintenance of clear specifications for standard content across the data lifecycle, including data collection, delivery, analysis reporting, aligned with program requirements and medical writing. Examples of standard content:
- Analysis Data Model metadata (ADaM)
- Template spreadsheets for adverse events and medications of interest, laboratory toxicities/abnormalities.
The role is responsible for acquiring and maintaining deep expertise in the various data collection and analysis tools and templates applied in the clinical trials, specifically those in use in J&J (e.g., AUTOCODE), in industry standards, including but not limited to CDISC standards (ADaM and define.xml) and adjacent data standards (e.g., HL7 / FHIR, OHDSI/OMOP).
The role should be knowledgeable in using common clinical data tools such as LSAF, Pinnacle 21, or SAS. The position may also be involved in innovative projects which requires learning of new tools and standards.
The role is responsible for remaining aware of the industry standards development and trends, and regulatory requirements, to support the development strategy and evolution of the J&J.
The role may also have responsibility for providing operational expertise in cross functional initiatives.
Qualifications / Requirements:
- A Bachelor's degree in a scientific, technology or healthcare discipline, or equivalent experience. Advanced degrees preferred (e.g., Master, PhD).
- At least 6 years of relevant pharmaceutical/scientific experience in a related discipline; e.g., data management, biostatistics, clinical or statistical programming.
- Expert knowledge of relevant regulatory requirements (e.g., GCP, ICH) and industry standards (e.g., SDTM, ADaM).
- Demonstrated written and verbal communications skills.
- Demonstrated customer focus and solution-oriented experience.
- Demonstrated interpersonal skills to build relationships with internal and external business partners.
- Demonstrated leadership on cross-functional projects.
- Demonstrated leadership in decision making and problem solving.
- Excellent spoken and written English.
Benefits:
We offer a competitive salary and extensive benefits package. The health and well-being of our employees is a priority, we have a flexible working environment as we value work-life balance. We offer career development opportunities for those who want to grow and be part of our organisation.
Johnson & Johnson Family of Companies are equal opportunity employers, and all qualified applicants will be considered for employment without regard to any other characteristic protected by law. We will ensure that individuals with disabilities are provided a reasonable accommodation to participate in the job application or interview process, to perform crucial job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation.
Required Skills:
Clinical Data Standards, Data Analysis Reporting, Data Collection Methods
Preferred Skills:
Biostatistics, CDISC ADaM, Clinical SAS Programming, Cross-Functional Leadership, Data Management, Regulatory Requirements, Statistical Programming
Manager, Standards Management Expert (ADaM) in Milton Keynes employer: Johnson & Johnson
Contact Detail:
Johnson & Johnson Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land Manager, Standards Management Expert (ADaM) in Milton Keynes
✨Tip Number 1
Network like a pro! Reach out to current or former employees at Johnson & Johnson on LinkedIn. Ask them about their experiences and any tips they might have for landing the Manager, Standards Management Expert role. Personal connections can give you insights that job descriptions just can't.
✨Tip Number 2
Prepare for the interview by diving deep into the company’s values and recent projects. Johnson & Johnson is all about innovation in healthcare, so think about how your skills in data management and standards can contribute to their mission. Show them you’re not just a fit for the role, but for the company culture too!
✨Tip Number 3
Practice your STAR technique for behavioural questions. Structure your answers around Situation, Task, Action, and Result. This will help you articulate your past experiences clearly and demonstrate how you’ve tackled challenges relevant to the role.
✨Tip Number 4
Don’t forget to apply through our website! It’s the best way to ensure your application gets seen. Plus, it shows you’re serious about joining the team. Make sure to tailor your application to highlight your expertise in clinical data standards and your passion for innovative medicine.
We think you need these skills to ace Manager, Standards Management Expert (ADaM) in Milton Keynes
Some tips for your application 🫡
Tailor Your CV: Make sure your CV is tailored to the role of Manager, Standards Management Expert (ADaM). Highlight your relevant experience in clinical data standards and any specific tools you've used. We want to see how your background aligns with what we're looking for!
Craft a Compelling Cover Letter: Your cover letter is your chance to shine! Use it to explain why you're passionate about this role and how your skills can contribute to our mission at Johnson & Johnson. Keep it concise but impactful – we love a good story!
Showcase Your Communication Skills: Since this role involves collaboration with various partners, it's crucial to demonstrate your written communication skills. Use clear and professional language throughout your application. Remember, clarity is key!
Apply Through Our Website: We encourage you to apply through our official website. It’s the best way to ensure your application gets into the right hands. Plus, you’ll find all the details you need about the role and our company culture there!
How to prepare for a job interview at Johnson & Johnson
✨Know Your Standards
Make sure you have a solid understanding of clinical data standards, especially ADaM and CDISC. Brush up on the latest regulatory requirements and industry trends, as this knowledge will show your commitment to the role and help you answer technical questions confidently.
✨Showcase Your Leadership Skills
Prepare examples that highlight your leadership experience in cross-functional projects. Think about times when you've successfully guided teams or made impactful decisions. This will demonstrate your ability to manage standards and collaborate effectively with various partners.
✨Communicate Clearly
Practice articulating your thoughts clearly and concisely. Since the role requires excellent written and verbal communication skills, consider doing mock interviews with a friend or using online platforms to refine your delivery and ensure you can convey complex ideas simply.
✨Emphasise Your Problem-Solving Abilities
Be ready to discuss specific challenges you've faced in previous roles and how you approached solving them. Highlight your solution-oriented mindset and customer focus, as these traits are crucial for the Manager, Standards Management Expert position.