Clinical Data Lead
This is an exciting opportunity for a Clinical Data Lead to work within a fast paced, busy environment for a leading global provider of outsourced development services to the pharmaceutical, biotechnology and medical device industries. This role can be based in either Ireland, UK, Spain and France.
- Read, ensure understanding and adhere to all assigned Client SOPs and working procedures.
- Ensure all work performed is of high quality , compliant with Good Clinical Practice, ICH Guidelines and all applicable laws and regulations.
- Complete all assigned training (including the COL Development Program) and courses in the Training Management system
- Record all billable and non-billable time in the appropriate timesheet management system
- Independently prepare all materials and take part in study kick off (internal and external) meeting.
- Lead development of the data management plan and study specific procedures.
- Ensure effective implementation of standard metric and status reporting on the study.
- Lead development of specifications for custom reporting on the study.
- Maintain and track meeting minutes, issues and decisions logs, and escalations.
- Deliver training to cross-functional study team members both internal and external (e.g. training in the study specific electronic CRF for monitors or Site staff at the investigatory meeting).
Skills and Requirements
- A minimum of 5 years clinical data management experience including 3 years' experience as a data management lead or point of contact for day to day activity on studies
- EU/APAC: Prior relevant clinical research industry experience.
- Experience of at least one of the preferred CDMS (e.g. Rave, Inform, Oracle Clinical, OCRDC, UX EDC)
- Highly computer literate, including strong Microsoft Office skills (Excel, Word, PowerPoint, Project).
- Excellent communication and interpersonal skills, both verbal and written skills.
- Strong client relationship management skills and the aptitude to develop this further.
- Excellent organizational and planning skills as well as a demonstrated aptitude for project management, and the ability to lead more than one project and prioritize accordingly.
Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.