Study Start-Up Lead
Employment Information
Report this job
Job expired or something wrong with this job?
Job Description
Study Start-Up Lead coordinating global clinical trial activation for ICON, a clinical research organisation. Managing documents, submissions, vendors, budgets, and site readiness to accelerate patient access to medicines.
Responsibilities:
- Contribute SSU insights to the trial Operational Execution Plan and align the SSU plan and strategy with the Study Leader/Clinical Trial Team
- Configure and ensure trial-specific set-up of SSU systems, including eTMF, CTMS, milestones, tasks, vendors, translations, countries, enrollment, contracting, budgeting, and ICF tools
- Prepare global SSU planning and lead the SSU Team from kick-off through completion of study start-up
- Ensure timely collection and eTMF filing of global trial-level documents for health authority and Ethics Committee submissions and site activation
- Support the Vendor Program Manager with global vendor activation and health authority submission documents
- Ensure global Protocol and ICF templates are ready for country use, including translations
- Direct investigator grant planning, fair-market-value assessment, and country site budget and contract template readiness
- Maintain global accountability for study start-up TMF timelines, accuracy, quality, and inspection readiness
Requirements:
- Must have the right to work in the UK, Spain, Poland, or Bulgaria
- Relevant experience in a similar role, ideally within a senior SSU role
- Experience working within the Clinical Research, Biotech, or Pharmaceutical industry
- Ability to start a new role within 4–8 weeks is highly advantageous
Benefits:
- Competitive base salary and performance related incentives
- Health and wellbeing programmes including medical, dental, and vision coverage where applicable
- Retirement and pension plans
- Life assurance and disability coverage
- Employee assistance programmes and wellbeing resources
- Learning and development opportunities through structured training and career pathways
Similar Jobs
Cruise & Resort Booking Specialist
Independent remote travel agent designing customized resort, cruise, and vacation packages. Booking reservations, recommending upgrades, and serving travelers with training and mentorship.
Senior Agile Master
Agile Master senior guiding agile teams at Colombian software engineering company. Ensuring effective communication, optimal workflow, and delivery of project results.
Lead Shift Server
Part-time Lead Shift Server providing food and beverage service to residents and guests at Senior Lifestyle’s Wellington at Hershey’s Mill community. Maintaining dining-area sanitation, coordinating room service, and training shift staff.
Junior Acquisition Specialist
Jr. Acquisition Specialist supporting federal acquisition activities for Martek Global Services, a provider of real estate, healthcare, facilities, and professional services. Preparing acquisition documents and supporting contract awards, administration, modifications, and closeouts.
Coordinator, Charge Revenue Integrity
Revenue Integrity Coordinator validating hospital charges, coding, and billing documentation for Trinity Health. Supporting ancillary departments and improving charge accuracy across healthcare operations.
Small Business Engagement Lead
Small-business engagement lead helping underserved suppliers navigate public procurement through Civic Marketplace’s digital platform. Building supplier partnerships, education programs, and scalable engagement operations nationwide.
Title Coordinator
Title Coordinator supporting First American’s global title and escrow operations. Coordinating complex transactions, title production, training, and AI-enabled process improvements remotely across the US.
Senior Project Specialist
Senior Project Specialist coordinating banking, wealth management, and trust-services projects at First American. Managing schedules, budgets, risks, milestones, and cross-functional stakeholder communications.
ADHD Specialist
ADHD Specialist providing virtual executive-function coaching for Texas Sports Academy, a K-12 school for elite student-athletes. Supporting academic progress through individualized routines, group sessions, and collaboration with guides, coaches, and parents.
Dyslexia Specialist
Dyslexia Specialist delivering virtual structured literacy and reading intervention for Texas Sports Academy student-athletes. Monitoring progress, coordinating accommodations, and supporting families across the online K-12 learning environment.
Revenue Protection Specialist
Revenue Protection Specialist analyzing hospital registration performance and denials for Trinity Health, a large nonprofit health care system. Driving revenue-cycle improvements, reporting trends, and implementing denial-resolution solutions.
Psychometrician
Psychometrician conducting Rasch-based analyses for WIDA ACCESS at the nonprofit Center for Applied Linguistics. Developing quality controls, technical reports, and quantitative guidance for language assessment research.
Language Testing Specialist
Language Testing Specialist developing WIDA English proficiency assessments for multilingual K–12 learners at nonprofit CAL. Writing, reviewing, and analyzing test items and field-test data.
Cardiac Device Specialist
Part-time Cardiac Device Specialist analyzing and reprogramming pacemakers, ICDs, and loop recorders for Allegheny Health Network. Supporting cardiology telemonitoring, patient follow-up, education, and EKG testing.
CAP Early Childhood (Apprenticeship)
Apprenti CAP AEPE gardant des enfants à domicile pour une entreprise partenaire du CFA Espace Concours. Suivi d'une formation à distance rémunérée et prise en charge, avec accompagnement pédagogique.
CAP Early Childhood Care (AEPE), Apprenticeship
Apprenti CAP AEPE gardant des enfants à domicile pour une entreprise partenaire du CFA Espace Concours. Formation à distance rémunérée et diplôme d’État pris en charge.
Inventory Coordinator
Inventory Coordinator managing retail and wholesale inventory for a fast-paced retailer. Handling purchase orders, replenishment, product data, reporting and website administration remotely.
Senior Specialty Triage RN – Cancer Center
Remote oncology triage RN supporting Providence’s cancer clinics through symptom assessment, guidance, documentation, and care escalation. Applying evidence-based protocols to promote safe access to oncology services.
Freelance Virtual-Building Scheduling Specialist
Remote Building Scheduling Specialist coordinating construction installation schedules for WolfSteel Buildings. Verifying orders, managing contractor availability, and updating bilingual clients throughout projects.
Deployment Specialist, Propagation Modeling
Deployment Specialist supporting Tantalus smart-grid deployments for U.S. utility customers. Troubleshooting TRUConnect hardware, software, networks, databases, and cloud environments.