Manager, Standards Management Expert (ADaM)

Job Description

At [Employer hidden — sign up to reveal], we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured. 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 organization's 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 [Employer hidden — sign up to reveal]’s Credo and Leadership Imperatives into team goals and decision making.

Responsibilities

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 include Analysis Data Model metadata (ADaM) and 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 at [Employer hidden — sign up to reveal] (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.

Qualifications

• Bachelor’s degree in a scientific, technology or healthcare discipline, or equivalent experience. Advanced degrees preferred.
• 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. [Employer hidden — sign up to reveal] Family of Companies are equal opportunity employers. We will ensure that individuals with disabilities are provided a reasonable accommodation to participate in the job application or interview process.

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