eCOA Standards Manager

• Job Title:
  eCOA Standards Manager
• Location:
  Remote in Belgium
• Salary:
  €100,000 - €125,000

RBW Consulting is partnered with a global biopharma company known for it's strong clinical data, regulatory success, team harmonization, commitment to research, patient centricity, and innovative treatments.

PURPOSE OF THE FUNCTION

The eCOA Standards Manager is a specialist in electronic clinical outcome assessments (eCOA) data ingestion and standardization. This role involves close collaboration with the Trial Operations eCOA Lead, Health Economics Outcomes Research (HEOR), and Global Sourcing and Vendor Alliance Management experts to enhance eCOA efficiency across the portfolio.

REPORTING LINE

The eCOA Standards Manager reports directly to the Head of Data Standards (Data Acquisition) and has a dotted-line reporting relationship to the Trial Operations eCOA Lead.

ROLES AND RESPONSIBILITIES

• Lead cross-functional teams to develop standards for eCOA data, standardized Data Transfer Agreements (DTAs), and SDTM data mappings.
• Support the portfolio in all aspects of eCOA data ingestion, standardization, and linking with clinical endpoints.
• Ensure CDISC-compliant mapping of COA data by creating and maintaining a library of SDTM metadata for COAs.
• Serve as the lead for eCOA technology, systems, and integrations.
• Act as the escalation point for study-specific eCOA data management issues.
• Lead the Near Real-Time Data Flow for eCOA, including weekly vendor transfers for internal SDTM creation, quality control, and insight generation tools.
• Optimize data acquisition processes in clinical trials by exploring opportunities to streamline and integrate data, enhancing efficiency and data quality.
• Stay updated on regulatory requirements and new industry trends and technologies concerning COAs, and inform relevant stakeholders as needed.
• Participate in regulatory agency inspections and internal audits when appropriate.

SKILLS AND COMPETENCIES

• Knowledge of ICH-GCP and other applicable legislation.
• Familiarity with CDISC standards (SDTM).
• Attention to detail and strong analytical skills.
• Ability to work independently.
• Strong communication and interpersonal skills.
• Proficiency in English (written and spoken).

EDUCATION, EXPERIENCE, AND QUALIFICATIONS

• Master's or Bachelor's degree in Biomedical or a related field, or equivalent experience.
• At least 6 years of experience in Clinical Data Management (experience in biotech is a plus).
• Expertise in eCOA data as a Subject Matter Expert in a biotech or pharma organization.
• Knowledge of eCOA processes and systems.
• Experience working in a Data Standards team.
• In-depth understanding of Clinical Development processes.
• Good knowledge of applicable regulatory guidelines.

To apply

Please click 'apply' or contact Joe Pearce for any further information

About RBW Consulting

RBW Consulting is a life sciences talent & strategic consultancy with purpose, delivered through what we call Human Intelligence. We help life sciences businesses change the world by giving them the people, insight & networks to innovate and scale. We are proud of our role in helping companies deliver better health and wellbeing outcomes for patients We give back by playing an active role in funding initiatives that change lives We've created a culture rooted in support, transparency and mutual commitment. We lead with our values from the inside; empowering and investing in our people is more important than short-term commercial gain.

We are an equal opportunities Recruitment Business and Agency

RBW Consulting is an equal opportunity workplace. We prioritize talent (both current and potential) over resumes, challenge the status quo, and value people as our most important asset. We do not discriminate on the basis of race, ethnicity, colour, sex, gender identity or expression, sexual orientation, religion, age, marital status, visible or invisible disability, medical condition, national origin, veteran status, or any other protected status. We strive to be a diverse workforce that is representative at all levels and are committed to building a team that represents a variety of backgrounds, perspectives, and skills.