Senior Manager Clinical Data Standards

TN United Kingdom; High Wycombe; Hybrid; GBP 60,000 - 90,000; Full time

Job summary

A leading company in healthcare innovation seeks a Senior Manager for Clinical Data Standards in High Wycombe. This role involves guiding projects to ensure compliance with clinical data standards, mentoring junior colleagues, and integrating leadership imperatives into team goals. Candidates should have extensive experience in data management and regulatory requirements, with a focus on delivering impactful results.

Benefits

Flexible working environment

Career development opportunities

Competitive salary and extensive benefits package

Qualifications

• At least 8 years of relevant pharmaceutical/scientific experience.
• Minimum 5 years SDTM experience essential.
• Expert knowledge of relevant regulatory requirements.

Responsibilities

• Facilitate programs and initiatives for Clinical Data Standards.
• Develop processes for accurate clinical data standards.
• Lead implementation of new technologies for data standards.

Skills

Leadership

Data Management

Communication

Problem Solving

Interpersonal Skills

Education

Bachelor’s degree in a scientific, technology or healthcare discipline

Advanced degrees preferred (e.g., Master, PhD)

Tools

Clinical Data Tools (e.g., LSAF, Pinnacle 21)

CDISC standards (e.g., SDTM, ADaM)

Job description

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Senior Manager Clinical Data Standards, High Wycombe

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Client:

Johnson and Johnson

Location:

High Wycombe, United Kingdom

Job Category:

Other

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EU work permit required:

Yes

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Job Reference:

2b2f0ad16be5

Job Views:

3

Posted:

21.05.2025

Expiry Date:

05.07.2025

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Job Description:

At Johnson & Johnson,we believe health is everything.
Our strength in healthcare innovation empowers us to build aworld where complex diseases are prevented, treated, and cured,where treatments are smarter and less invasive, andsolutions 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.Learn more at https://www.jnj.com Job Function: Data Analytics & Computational Sciences Job Sub Function: Clinical Data Management Job Category: Professional All Job Posting Locations: High Wycombe, Buckinghamshire, United Kingdom Job Description: Senior Manager Clinical Data Standards 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.
Learn more at https://www.jnj.com/innovative-medicine We are searching for the best talent for a Senior Manager Clinical Data Standards, within Integrated Data Analytics & Reporting (IDAR), to guide the execution of projects, programs, and processes that span multiple related areas in support of the organisation's overall Clinical Data Standards strategy.
You will apply comprehensive knowledge of Clinical Data Standards to install best in class policies, procedures, and plans for the area, ensuring consistency of clinical data standards across clinical trials and in compliance with regulatory requirements. The role may be located in Beerse, Belgium; High Wycombe, United Kingdom; or Leiden, Netherlands (Hybrid / 3 days onsite per week). Are you ready to join our team? Then please read further! You will be responsible for: * Acting independently to facilitate programs and innovative initiatives for the organisation to advance Clinical Data Standards solutions. * Working to achieve operational, functional, and business targets with measurable impact on results for the Clinical Data Standards area. * Developing processes to provide accurate, timely, and consistent clinical data standards to study teams. * Leading the implementation of new technologies for development and implementation of clinical data standards. * Guiding junior colleagues through consultation and mentoring in techniques and processes, and provides functional (matrix) supervision. * Integrating Johnson & Johnson’s Credo and Leadership Imperatives into team goals and decision making. The Data Delivery Standards Senior Manager is responsible for the development and maintenance of standard content supporting the data flow from collection to SDTM.
Examples of standard content are: * Controlled Terminology (CT) * Study Data Tabulation Model (SDTM) * Annotated Case Report Forms (aCRFs) * Support Data Transfer Agreement (DTA) standards with SDTM * Mapping metadata from data collection (CRF and DTA) to SDTM. The Data Delivery Standards Senior Manager is responsible for acquiring and maintaining deep expertise in the various data collection tools applied in the clinical trials such as DTAs, Clinical Data Tools such as LSAF and Pinnacle 21, and in CDISC standards such as STDM, CDASH, Controlled Terminology, and define.xml. Principal Relationships: Internal: Align, collaborate, advise, and share best practices with other functions and teams in Therapeutic Areas, Global Development, Regulatory Affairs, Data Sciences, Clinical Data Standards and others as needed.
External: Interact and collaborate with vendors.
Act as J&J representative for defining process standards and sharing practices with industry counterparts and working groups, as required. Education and Experience Requirements: * A bachelor’s degree in a scientific, technology or healthcare discipline, or equivalent experience.
Advanced degrees preferred (e.g., Master, PhD) * At least 8 years of relevant pharmaceutical/scientific experience in a related discipline; e.g., data management, biostatistics, clinical or statistical programming * Minimum 5 years SDTM experience essential! * 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 Please note that this role is available across multiple countries and may be posted under different requisition numbers to comply with local requirements.
While you are welcome to apply to any or all of the postings, we recommend focusing on the specific country(s) that align with your preferred location(s): Belgium/Netherlands - Requisition Number: R-013845 United Kingdom -Requisition Number: R-014851 Remember, whether you apply to one or all of these requisition numbers, your applications will be considered as a single submission. 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. #LI-Hybrid