- Company Name
- Allucent
- Job Title
- Project Data Manager - Europe
- Job Description
-
**Job Title:** Project Data Manager – Europe
**Role Summary:**
Leads and coordinates end‑to‑end clinical data management activities for complex trials and biometrics projects, ensuring high‑quality, compliant data delivery on schedule and within budget. Serves as primary liaison with sponsors, vendors, and internal teams, while supervising junior staff and managing project finances.
**Expectations:**
- Take full ownership of data management deliverables across study lifecycle.
- Maintain clear communication, risk escalation, and issue resolution with all stakeholders.
- Drive project timelines, scope, quality, and budget adherence.
- Mentor and develop junior data management personnel.
**Key Responsibilities:**
- Design, build, and validate electronic data capture (EDC) databases; oversee data cleaning, review, and lock.
- Act as the main point of contact for sponsors, vendors, and internal teams on data management matters.
- Plan, coordinate, and execute biometrics and clinical data projects per contractual scope and timelines.
- Develop and maintain communication, escalation, and risk‑management plans.
- Lead kickoff, status, and sponsor meetings; facilitate decision‑making.
- Select, manage, and oversee external vendors as required.
- Monitor project budgets, financial health, and produce monthly status reports.
- Supervise junior DM staff, ensuring quality output and professional growth.
**Required Skills:**
- ≥8 years clinical data management or biometrics experience across all study phases (I‑IV).
- Proven experience as DM Lead on multiple indications and complex studies.
- Strong knowledge of ICH‑GCP, 21 CFR 11, GDPR/HIPAA, and regional data‑privacy regulations.
- Expertise with EDC systems (Medidata, Veeva) and technical DM practices (validation, testing, documentation).
- Proficiency in CDISC standards (CDASH, SDTM, ADaM) and hands‑on implementation.
- Ability to manage sponsor and vendor relationships confidently.
- Excellent written and verbal communication in English; collaborative, global‑team mindset.
- Leadership and mentoring capability.
**Required Education & Certifications:**
- Bachelor’s degree in Life Sciences, Healthcare, or related field (or equivalent combination of education and experience).
- Relevant certifications (e.g., CDISC, SAS, or project management) preferred but not mandatory.