The CompanyA leading international organization specializing in consulting and digital solutions for the Life Sciences sector, headquartered in Italy. Founded in 2010, the company supports pharmaceutical and biotech organizations across regulatory affairs, pharmacovigilance, clinical trials, medical affairs, and quality assurance. It delivers innovative digital tools and high value‐added services, with a strong focus on regulatory compliance and operational efficiency.
The RoleAs a Senior Digital Clinical Consultant, you will be responsible for gathering and translating clinical requirements into technical specifications, ensuring project governance, managing client relationships, and coordinating the implementation of digital solutions. You will act as a key reference point in initiatives aimed at modernizing clinical processes, working closely with IT teams, technology vendors, QA functions, and study sponsors.
Key Responsibilities
Lead the implementation of eClinical systems (eTMF, CTMS, EDC, SCE, eConsent, eISF)
Translate clinical functional requirements into scalable technical solutions
Coordinate system architectures, integrations, configurations, and validations
Perform process assessments (study startup, site management, monitoring, data management, TMF)
Identify gaps, inefficiencies, risks, and automation opportunities
Propose technology road maps and operational plans for digital innovation
Manage project milestones, budgets, KPIs, and overall progress
Produce technical and project documentation (URS, FS, DS, validation plans, gap analysis, test scripts)
Ensure compliance with ICH GCP, ICH E6(R3), GxP standards, and applicable regulations
Contribute to the development of new digital offerings for Clinical Operations
You Are the Ideal Candidate If You
Have at least 7–10 years of experience in clinical or eClinical environments, preferably in tech‐driven settings
Hold a degree in Bioinformatics, Computer Science, Biomedical Engineering, or related disciplines
Have prior experience in consulting roles with direct client interaction
Have a strong understanding of clinical operations workflows and ICH GCP / ICH E6(R3) guidelines
Have hands‐on experience with digital clinical systems (CTMS, eTMF, EDC, SCE, RTSM, eConsent)
Possess a strong technical mindset, including system configuration, data analysis, integrations, and digital platform management
The Company Offers
Competitive salary and benefits package
Flexible working arrangements (full remote or hybrid options)
A dynamic and innovative environment with a strong focus on regulated industries
All vacancies are open to candidates of all genders (Law 903/77).
To check whether this position is still open, please visit https://cpltaylor.it/annunci/#/ and enter the job reference code.
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Seniority level
Associate
Employment type
Full‐time
Job function
Information Technology
Industries
Chemical Manufacturing and Pharmaceutical Manufacturing
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Contact Detail:
CPL & TAYLOR by Synergos srl Recruiting Team