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Site Activation Manager – Clinical Operations Manager
Syneos Health. Manage performance and compliance for assigned clinical trial protocols in Spain .
Core Competencies
Role fitCore Competencies
Use this summary to align your resume positioning with the role.
Demonstrates expertise in managing clinical trial protocols, ensuring compliance with local regulations, and overseeing financial aspects including budgeting and contract negotiations. Proficient in coordinating with various stakeholders to deliver quality results within established timelines.
Highest-signal resume keywords
Clinical Trial ManagementBudget NegotiationRegulatory ComplianceFinancial ForecastingStakeholder Coordination
ATS Keywords
Tailor your resumeApplicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills
Clinical ResearchFinancial ManagementRisk ManagementContract DevelopmentClinical Trial Research AgreementsLocal Regulatory KnowledgeClinical Systems ExpertisePayment ReconciliationSubmission ProcessesQuality Assurance
Soft Skills
Strong CommunicationLeadershipNegotiationProblem-SolvingOrganizational Skills
Tools & Technologies
SCOMClinical Trial Management SystemsFinancial Systems
Industry Keywords
ICH/GCPFCPADPS/OFACIRB/IECHealth CareClinical TrialsAdverse Event Reporting
Tech Stack
Tools & technologiesGoogle Cloud Platform
About the role
Key responsibilities & impact- Manage performance and compliance for assigned clinical trial protocols in Spain
- Own country and site budgets
- Develop, negotiate and complete Clinical Trial Research Agreements (CTRA)
- Oversee and track clinical research-related payments and reconcile payments at study close-out
- Oversee FCPA, DPS/OFAC and financial systems maintenance
- Perform financial forecasting with SCOM and other roles
- Execute and oversee clinical trial country submissions and approvals
- Develop local-language materials, informed consents and translations
- Interact with IRB/IEC and Regulatory Authorities
- Manage country deliverables, timelines and results for assigned protocols
- Ensure quality and compliance for assigned protocols
- Contribute to local SOP development and oversee CTCs as applicable
- Coordinate with CRM, CTC, CRA, Finance and Legal to obtain country deliverables
- Collaborate with Headquarters to align country timelines
- Support and oversee local vendors
- Coordinate local processes, clinical and ancillary supplies, importing/exporting, supplies destruction, filing, archiving, retention and insurance processes
- Enter and update country information in clinical and finance systems
- Maintain local regulatory and financial compliance
- Influence investigators, external partners and country operations to meet budget targets and payment timelines
- Partner with internal country operations, finance, regulatory affairs, pharmacovigilance, legal, regional operations and HQ teams, and external vendors, sites, IRB/IECs and Regulatory Authorities
- Deliver clinical and financial contracts within fair market value
Requirements
What you’ll need- Bachelor's Degree in Business Finance/Administration/Life Science or equivalent Health Care related experience
- 5 years of experience in clinical research or combined experience in Clinical Research and Finance/Business
- Expertise of core clinical systems, tools and metrics
- Excellent English skills
- Strong coordination and organizational skills
- Knowledge of budget and contract negotiations
- Knowledge of local regulatory environment and submission and approval processes
- Ability to influence investigators, vendors, external partners and country managers
- Ability to make decisions independently with limited oversight
- Ability to develop risk management and mitigation plans
- Strong problem-solving skills
- Strong communication, leadership, negotiation, influencing, training and mentoring skills, written and verbal, in local language and English
- Ability to manage multiple deliverables and protocols simultaneously
- Ability to work effectively in a remote virtual environment
- Willingness to work in compliance with ICH/GCP, country regulations, client policies, quality standards and adverse event reporting requirements
Benefits
Comp & perks- Career development and progression
- Supportive and engaged line management
- Technical and therapeutic area training
- Peer recognition
- Total rewards program
- Inclusive culture
- Remote work arrangement