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Planet Pharma is pleased to be recruiting for a Clinical Data Standards Manager to work with a leading clinical trials organisation in Europe. This is a full-time, permanent position and candidates can be based out of Switzerland or Belgium only.
ROLES AND RESPONSIBILITIES
Take a leadership role in cross-functional teams to create standards for e COA data, standardized Data Transfer Agreements (DTA’s), and SDTM data mappings.
Support the portfolio on all aspects of e COA data ingestion, standardization, linking with clinical endpoints, etc.
Ensure CDISC compliant mapping of COA data by creating & maintaining a library of SDTM metadata for COAs.
Serve as Lead for e COA technology/systems and integrations.
Act as an escalation point for study-specific e COA 'DM-related' issues.
Lead e COA efforts for Near Real-Time Data Flow, including weekly e COA vendor transfers for internal SDTM creation, QC, and insight generation tools.
Support the optimization of data acquisition processes in clinical trials by exploring opportunities to streamline and integrate data, enhancing efficiency and data quality.
Stay informed of regulatory requirements and industry trends concerning COAs, and communicate relevant updates to stakeholders.
Participate in regulatory inspections and internal audits as appropriate.
SKILLS AND COMPETENCIES
Knowledge of ICH-GCP and other applicable legislation.
Proficiency in CDISC standards (SDTM).
Ability to work independently.
Strong communication and interpersonal skills.
Fluent 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 8 years of experience in Clinical Data Management, with biotech experience being a plus.
Experience with e COA data as Subject Matter Expert in a biotech or pharma organization.
Knowledge of (e)COA processes and systems.
Experience working in a Data Standards team.
In-depth understanding of Clinical Development processes.
Good knowledge of regulatory guidelines.
Additional Information
Seniority level: Mid-Senior level
Employment type: Full-time
Job function: Analyst and Research
Industries: Pharmaceutical Manufacturing and Biotechnology Research
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