Syneos Health, Inc.
Overview
Site Activation Specialist II – Syneos Health® is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success. We translate unique clinical, medical affairs and commercial insights into outcomes to address modern market realities. Our Clinical Development model centers the customer and patient, and we collaborate in functional service provider or full-service environments to accelerate delivery of therapies that change lives. Discover what our 29,000 employees across 110 countries already know:
WORK HERE MATTERS EVERYWHERE . Job Responsibilities
Responsible for quality deliverables at the country level; follow project requirements and applicable country rules with moderate oversight from the SSU Country Manager. Work within forecasted submission/approval timelines, track milestone progress in the SSU tracking system in real time, investigate delays, provide rationale, support contingency plans, and escalate issues as identified. Monitor basic financial aspects of the project and the number of hours/tasks available per contract; escalate discrepancies timely. Review and comply with SOPs/WIs; keep training records updated and ensure timesheet compliance. Support continuous improvement of quality in all Site Start-Up (SSU) components at the country level (submissions, essential document collection, communications to Competent Authorities and ECs, etc.). Ensure all relevant documents are submitted to the Trial Master File (TMF) as per SOP/Sponsor requirements. Responsible for Local Submissions Specialist - follow project direction from CSA and SAM; may act as a point of contact during start-up. Prepare and submit Central/Local EC Applications, RA Applications, and other local regulatory submissions as required. Prepare ongoing submissions, amendments, and periodic notifications for central/local authorities as needed with moderate oversight from the SSU Country Manager. May liaise between investigational sites and functional leads; oversee site activation end-to-end at country/site level. Country Start-Up Advisor – act as Subject Matter Advisor for in-country performance in Site Start-Up; maintain local regulatory intelligence; support data protection statements; provide input to local SOPs/WIs; assist EC/CA issue resolution at country level. Includes Local Site ID and Feasibility Support for site selection. May perform Local Investigator Contract and Budget Negotiator duties: assist SAM in contracting and budgeting with sites; prepare site-specific contracts; support submissions for contracts and budgets; negotiate budgets and contracts with sites; ensure CTAs are executed and documents archived with metadata. Qualifications
Bachelor’s Degree Detailed understanding of the clinical trial process across Phases II-IV and ICH GCP Ability to understand clinical protocols and study specifications Detailed understanding of clinical trial start-up processes Ability to manage external vendors to contract effectively Strong organizational, written, and verbal communication and interpersonal skills Ability to manage multiple project budgets with increasing complexity and value Quality-driven approach; good problem-solving skills Demonstrated ability to work independently and as part of a team Get to know Syneos Health
Over the past 5 years, we have worked with 94% of all Novel FDA Approved Drugs, 95% of EMA Authorized Products and over 200 studies across 73,000 sites and 675,000+ trial patients. We are committed to a diverse, equitable and inclusive culture. What you’ll do matters. Learn more about Syneos Health. Website: http://www.syneoshealth.com Additional Information
Tasks, duties, and responsibilities as listed are not exhaustive. The Company may assign other tasks at its discretion. An employment contract is not implied. The Company complies with applicable laws and promotes equal opportunity employment.
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Site Activation Specialist II – Syneos Health® is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success. We translate unique clinical, medical affairs and commercial insights into outcomes to address modern market realities. Our Clinical Development model centers the customer and patient, and we collaborate in functional service provider or full-service environments to accelerate delivery of therapies that change lives. Discover what our 29,000 employees across 110 countries already know:
WORK HERE MATTERS EVERYWHERE . Job Responsibilities
Responsible for quality deliverables at the country level; follow project requirements and applicable country rules with moderate oversight from the SSU Country Manager. Work within forecasted submission/approval timelines, track milestone progress in the SSU tracking system in real time, investigate delays, provide rationale, support contingency plans, and escalate issues as identified. Monitor basic financial aspects of the project and the number of hours/tasks available per contract; escalate discrepancies timely. Review and comply with SOPs/WIs; keep training records updated and ensure timesheet compliance. Support continuous improvement of quality in all Site Start-Up (SSU) components at the country level (submissions, essential document collection, communications to Competent Authorities and ECs, etc.). Ensure all relevant documents are submitted to the Trial Master File (TMF) as per SOP/Sponsor requirements. Responsible for Local Submissions Specialist - follow project direction from CSA and SAM; may act as a point of contact during start-up. Prepare and submit Central/Local EC Applications, RA Applications, and other local regulatory submissions as required. Prepare ongoing submissions, amendments, and periodic notifications for central/local authorities as needed with moderate oversight from the SSU Country Manager. May liaise between investigational sites and functional leads; oversee site activation end-to-end at country/site level. Country Start-Up Advisor – act as Subject Matter Advisor for in-country performance in Site Start-Up; maintain local regulatory intelligence; support data protection statements; provide input to local SOPs/WIs; assist EC/CA issue resolution at country level. Includes Local Site ID and Feasibility Support for site selection. May perform Local Investigator Contract and Budget Negotiator duties: assist SAM in contracting and budgeting with sites; prepare site-specific contracts; support submissions for contracts and budgets; negotiate budgets and contracts with sites; ensure CTAs are executed and documents archived with metadata. Qualifications
Bachelor’s Degree Detailed understanding of the clinical trial process across Phases II-IV and ICH GCP Ability to understand clinical protocols and study specifications Detailed understanding of clinical trial start-up processes Ability to manage external vendors to contract effectively Strong organizational, written, and verbal communication and interpersonal skills Ability to manage multiple project budgets with increasing complexity and value Quality-driven approach; good problem-solving skills Demonstrated ability to work independently and as part of a team Get to know Syneos Health
Over the past 5 years, we have worked with 94% of all Novel FDA Approved Drugs, 95% of EMA Authorized Products and over 200 studies across 73,000 sites and 675,000+ trial patients. We are committed to a diverse, equitable and inclusive culture. What you’ll do matters. Learn more about Syneos Health. Website: http://www.syneoshealth.com Additional Information
Tasks, duties, and responsibilities as listed are not exhaustive. The Company may assign other tasks at its discretion. An employment contract is not implied. The Company complies with applicable laws and promotes equal opportunity employment.
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