Clinical Study Site Start-Up Manager – London – Permanent
Nicholas Howard Limited are delighted to be recruiting for a new and exciting role as a Clinical Study Site Start-Up Manager.
The Clinical Study Start-Up Manager will be responsible for building and leading a high-performing Start-up team at the functional level, to execute on start-up activities in a fast-paced environment within Study Management. Partnering with internal stakeholders, the Manager will strive to establish operational efficiencies which translate to optimal investigative site experiences.
- Responsible for the line management and functional oversight of the assigned country Start-up Team (Site Activation Managers, ICF Reviewers, Start-up CTAs and Clinical Trial Coordinators).
- Oversees Start-up Team resourcing and recruitment to ensure proper allocation of resources in order to achieve study timelines and deliverables.
- Responsible for staff training, escalations/performance management, employee goal setting and growth opportunities.
- Defines and monitors key performance indicators and other metrics for country Start-up team.
- Develops and maintains Start-up Team operational plans, tools and guidance documents, ensuring compliance with applicable SOPs/WIs/local regulations and other department requirements.
- Proactively identifies systemic issues through cross-functional collaboration with internal and external stakeholders, and implements strategic solutions.
- Serves as functional representative to Central IRBs (US only).
- May serve as functional representative to TMF group, DrugDev Sites F1RST Portal and other internal systems to propose, develop and/or implement effective process improvements.
- This is not an exhaustive, comprehensive listing of job functions. Other duties may be performed as assigned.
- S. degree with a major in a related field (or equivalent experience) and good relevant work experience or Bachelor’s degree with a major in a related field and strong relevant work experience preferred.
Skills & Experience:
- Significant experience with line management of employees.
- Proven track record of management of long-term professional relationships.
- Must have good working knowledge of ICH, FDA, IRB/IEC and other applicable regulations/guidelines and significant experience with Investigative Site start-up documents.
To be considered for this position please apply below.