Study Start Up Manager
- United Kingdom
- Permanent
- Full-time
- Manage and may lead the day-to-day operations within Study Start Up to ensure completion per established goals and objectives in compliance with applicable GCP/ICH guidelines and other regulatory requirements. This includes effective communication and coordination with key business stakeholders (e.g. study teams) to support timely completion of both drug and non-drug program goals and objectives
- Manage and may lead functional and cross-functional internal teams
- Provide accurate and up-to-date project status and financial information (where appropriate) within relevant tracking systems/tools
- Proactively identify and escalate issues that arise related to support functional deliverables.
- Prepares and finalizes submission package for submission to IRB/IEC, (Europe: acc. to new EU-CTR) as well as Health Authorities as applicable (including subsequent amendments, IBs, DSURs, CSRs)
- Responsible for implementation of standards for designated functional areas.
- Provide oversight and direction to team members for functional and study-related deliverables
- Accountable for functional budgets and resources (where appropriate) and responsible for the management of related components of trial or support function budgets, timelines and resources. May also provide oversight for these activities.
- Responsible and may be accountable for all activities associated with Study Start Up. This may include:
- Oversight of SSU activities from receipt of a potential site list to site activation including CDA and questionnaire collection, site selection, IRB/EC submissions, IMP Release and other site activation requirements
- BA/BS degree with ≥5 years of experience in pharmaceutical related drug development or direct equivalent experience or advanced degree
- Must have knowledge of clinical trial conduct, including, multi-center, global trials.
- Experience within the EU-CTR
- Must have strong knowledge of ICH/GCP guidelines and regulatory requirements.
- Requires proven project management skills and leadership ability
- Must have excellent interpersonal, written and verbal communication skills, administrative skills and computer ability.
- Experience in working cross functionally and with external providers
- Experience with development & implementation of process improvement related initiatives
- Global Experience with site activation activities including submission requirements.
- Various annual leave entitlements
- A range of health insurance offerings to suit you and your family’s needs
- Competitive retirement planning offerings to maximise savings and plan with confidence for the years ahead
- Global Employee Assistance Programme, TELUS Health, offering 24-hour access to a global network of over 80,000 independent specialised professionals who are there to support you and your family’s well-being
- Life assurance
- Flexible country-specific optional benefits, including childcare vouchers, bike purchase schemes, discounted gym memberships, subsidised travel passes, health assessments, among others