Site Activation Manager/Clinical Operations Manager_ Madrid/Spain. Syneos Health® is a leading fully-integrated life sciences services organization built to accelerate customer success. We are agile and driven to deliver – for one another, our customers, and, most importantly, for those in need.
Why Syneos Health
supportive and engaged line management; technical and therapeutic area training; Because we know that when we bring together smart colleagues from across the world, we can shape the future of healthcare, driving impact for customers and defining the pace of patient progress.
This role is accountable for performance and compliance for assigned protocols in a country in compliance with ICH/GCP and country regulations, client policies and procedures, quality standards and adverse event reporting requirements internally and externally. The person is responsible for budget/finance aspects, for execution and oversight of clinical trial country submissions and approvals and to ensure Site Ready.
Ownership of country and site budgets. Development, negotiation and completion of Clinical Trial Research Agreements (CTRA).
~ Oversees and tracks clinical research-related payments. Payment reconciliation at study close-out. Executes and oversees clinical trial country submissions and approvals for assigned protocols.
~ Develops local language materials including local language Informed Consents and translations. Responsible for quality and compliance in assigned protocols in country.
~ Contributes to the development of local SOPs. Coordinates and liaises with CRM, CTC, CRA, (Finance and Legal if appropriate)



to ensure country deliverables are obtained for submissions, budgets, CTRAs and local milestones.
~ Provides support and oversight to local vendors as applicable.
~ Oversees and coordinates local processes, clinical and ancillary supplies management, importing and exporting requirements, supplies destruction, local electronic/hard copy filing, archiving and retention requirements, and insurance process management. Ownership of local regulatory and financial compliance. Required to in/directly influence investigators, external partners and country operations to adhere to partners and country operations to adhere to budget targets and agreed payment timelines.
~ Works in partnership internally with GCTO country operations, finance, regulatory affairs, pharmacovigilance, legal and regional operations, HQ functional areas and externally with vendors and sites, IRB/IECs and Regulatory Authorities in submission and approval related-interactions. Through continual interaction with local clinical team/s successfully delivers clinical and financial contracts within fair market value.
~ 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
~ Excellent English skills
~ skilled knowledge of budget and contract negotiations, local regulatory environment and submission and approval processes, and understanding of how these impact study start-up
~ Requires strong understanding of local regulatory environment
~ Ability to proactively develop risk management and mitigation plans in the country and resolve issues locally.
~ Requires the ability to pro-actively identify issues and risks, analyze root cause, and propose solutions to problems and elevate to management as applicable. 1) Issues in budget / CTRA negotiations, 2) Quality and compliance issues, 3) Regulatory and legal issues, and 4) issues related to functional area deliverables that could jeopardize protocol milestones.
~ Strong communication, leadership, and negotiation skills as well as excellent influencing and training/mentoring skills, both written and verbal, in local language and English
~ Requires that the individual has ability to work effectively also in a remote virtual environment with a wide range of people

Get to know Syneos Health
Learn more about Syneos Health.

Further, nothing contained herein should be construed to create an employment contract. The Company is committed to compliance with the Americans with Disabilities Act, including the provision of reasonable accommodations, when appropriate, to assist employees or applicants to perform the essential functions of the job.
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📌 Site Activation Manager/Clinical Operations Manager_ Madrid/Spain. FSP (España)
🏢 Syneos Health
📍 España