Would you like to join a leading Biotech who despite the challenges of the COVID-19 pandemic remains focused on executing their 2021 vision to become a fully integrated, global company?
You will be joining on a 12 month fixed term contract and be expected to hit the ground running, responsible for all data management aspects from initiation till closure ensuring that clinical data completeness, accuracy and consistency meet the standards of quality for analysis and reporting to regulatory bodies, compliant with the local and global regulations.
- Take a leadership role with the CRO, clinical study team and other internal and external partners to establish, align and conform data management expectations for the assigned trials.
- Set quality expectations and timelines for data management deliverables.
- Ensure compliance with SOPs, company policies and regulatory requirements from trial start-up to trial close-out.
- Keep track of project plan, budget, metrics and KPIs. Adjust project plan as needed in consultation with Data Management CRO and Clinical Team.
- Create Data Release Plan in consultation with applicable stakeholders and oversee Data Releases.
- Demonstrated experience leading studies fully life cycle
- Knowledgeable in GCP standards, CDISC standards (CDASH, SDTM, ADaM), FDA and ICH guidelines, and recommended CDM best practices
- Experience leading or participating in initiatives on process improvement
- Experience with tools and systems for managing
- Auto-immune and/or orphan disease clinical study background is a plus
This a full time home based position open to candidates in the UK and EU, with a salary of up to £57,000 plus great benefits.
If you would like to discuss this vacancy further, know the perfect candidate for the position or on the lookout for something similar please call Laura Varela on +44 (0) 203 189 0468 or email Lvarela@i-pharmconsulting.com.