Global Clinical Trial Manager II or Senior - Home Based Bulgaria

Syneos Health® is a leading fully-integrated life sciences services organization built to accelerate customer success. We partner with innovators at every point across the drug development and commercialization continuum, helping them navigate complexity, anticipate change and accelerate progress.

Our Clinical Solutions team members act with a drug development mindset, applying their years of experience and deep expertise to truly understand customer needs and represent those in the solutions we shape.

Whether you join us in a Functional Service Provider partnership or a Full-Service environment, you’ll collaborate with passionate problem solvers, innovating as a team to help our customers achieve their goals. We are agile and driven to deliver – for one another, our customers, and, most importantly, for those in need.

Discover what your 25,000 future colleagues already know:

Why Syneos Health
• We are passionate about developing our people, through career development and progression; supportive and engaged line management; technical and therapeutic area training; peer recognition and total rewards program.
• We are committed to building an inclusive culture – where you can authentically be yourself. Central to this is our purpose – Driven to Deliver – which captures the passion of our colleagues to show up each day and shape solutions that have the ability to dramatically impact someone’s life.
• We are continuously building the company we all want to work for and our customers want to work with. Why? 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.

Job Responsibilities

Responsible for site management oversight, clinical monitoring and central monitoring deliverables with a focus on patient safety, protocol/GCP/regulatory compliance and data integrity.
Oversees site interactions post activation through site closeout. This may include patient recruitment, investigator payments or other related activities.
May be responsible for identification of critical data and process, protocol execution risks and risk mitigations related to completion of the Risk Assessment and Categorization Tool (RACT).
Reviews the study scope of work, budget and protocol content and ensures the clinical project team (CRAs/Central Monitors) is aware of the contractual obligations and parameters.
Uses prior clinical experience, operational data, metrics and reports to identify risks to clinical trial management deliverables.
Escalates to the project manager any risks to clinical trial management deliverables (timeline, quality and budget) and any activities and requests which are out of contracted scope.
Employs strategic thinking and problem-solving skills to propose and implement risk mitigations.
Participates and presents in key meetings such as Kick Off Meeting.
Serves as an escalation point for communications with investigator site staff and may be required to interact on the phone or in person with principal investigators or other site staff members. This may include accompanying CRA team members to sites for observation or conflict resolution.
Collaborates with other functional leaders such as Study Start Up, Patient Recruitment and Data Management to coordinate delivery handoffs and meet expected study milestones such as site activation targets, enrollment targets and database lock timelines. Reviews and provides feedback on other functional plans (e.g. Data Management Plan, Communication Plan) as they relate to the clinical trial management activities.
Responsible for development and ongoing maintenance of clinical study tools and templates, including the Clinical Monitoring Plan. Ensures CTMS, dashboards and other systems are set up and available for use by the clinical team, including overseeing user acceptance testing (UAT) as needed. Ensures access and audit trail reviews are conducted as required.
Coordinates initial and ongoing training to the study team regarding protocol specificities, Case Report Form (CRF) completion, dashboards, Sponsor Standard Operating Procedures (SOPs), clinical plans and guidelines, data plans and timelines for the study.
Oversees resourcing allocations for CRAs and Central Monitors, site assignments and study team members' conduct, and identifies risks to delivery or quality.
Ensures quality of the clinical monitoring, central monitoring and site management deliverables within a project and maintain proper visibility of its progress by the use of approved systems and / or tracking tools.
Reviews the project oversight dashboards and other clinical trial systems (e.g. Clinical Trial Management System (CTMS), Electronic Data Capture (EDC), eDiary, Electronic Patient Reported Outcomes (ePROs),Trial Master File (TMF), IVRS/IWRS, Central Monitoring dashboards), to oversee site and patient activities, study team conduct and to ensure the data has been updated to reflect timely execution of all operational aspects (required visits/calls, duration, and frequency) according to plan.
Understands the monitoring strategy required for the study and, where required, participates in the development of the study risk assessment plan. Is accountable for their assigned clinical team members' understanding, ongoing compliance and delivery according to the stated monitoring strategy, CMP/SMP, and risk plans.
Reviews the content and quality of site and central monitoring documentation (site monitoring calls, site visit reports, site letters, central monitoring reports and pertinent correspondence), to ensure they represent site management activities and conduct and that they appropriately convey any risks to protocol/GCP compliance, trial conduct, patient safety or data integrity. Document requested revisions and approvals in CTMS. Ensures these deliverables are provided according to company and/or sponsor specifications, including delivery deadlines.
Interacts with the client and other functional departments related to clinical monitoring, central monitoring and site management activities and deliverables. Provides status updates on the clinical deliverables and risks to clients, project management and leadership as per departmental or study agreements. Provides solutions for obstacles in protocol execution and site management.
Demonstrates understanding of other functions' roles in achieving compliance and delivery according to protocol, SOPs, ICH GCP and country regulations. This may include data management, study start up, patient recruitment, medical monitoring, pharmacovigilance and Quality Assurance (QA). Supports Inspection Readiness for clinical trial management scope.
Oversees CRAs and Central Monitors assigned to the study and routinely assesses study-specific process and training compliance, CMP compliance, and identifies emerging risks. May develop and support execution of corrective action plans at site and study level. Supports and completes activities to achieve data cut and lock deadlines.
Provides feedback to line managers on staff performance including strengths as well as areas for development. May be assigned to larger,more complex trials.

Qualifications:

Bachelor’s degree or RN in a related field or equivalent combination of education, training and experience
Demonstrated ability to lead and align teams in the achievement of project milestones
Demonstrated capability of working in an international environment.
Demonstrated expertise in site management and monitoring (clinical or central)
Preferred experience with risk-based monitoring
Demonstrates understanding of clinical trial management financial principles and budget management
Knowledge of Good Clinical Practice/ICH Guidelines and other applicable regulatory requirements
Must demonstrate good computer skills
Good communication, presentation and interpersonal skills among project team and with sites
Strong conflict resolution skills
Demonstrated ability to apply problem solving techniques to resolve complex issues, and apply a risk management approach to identifying and mitigating potential threats to the successful conduct of a clinical research project.
Demonstrates critical thinking to determine the cause and appropriate solution in the identification of issues
Moderate travel may be required, approximately 20%

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.

No matter what your role is, you’ll take the initiative and challenge the status quo with us in a highly competitive and ever-changing environment. Learn more about Syneos Health.

http://www.syneoshealth.com

Additional Information

Tasks, duties, and responsibilities as listed in this job description are not exhaustive. The Company, at its sole discretion and with no prior notice, may assign other tasks, duties, and job responsibilities. Equivalent experience, skills, and/or education will also be considered so qualifications of incumbents may differ from those listed in the Job Description. The Company, at its sole discretion, will determine what constitutes as equivalent to the qualifications described above. Further, nothing contained herein should be construed to create an employment contract. Occasionally, required skills/experiences for jobs are expressed in brief terms. Any language contained herein is intended to fully comply with all obligations imposed by the legislation of each country in which it operates, including the implementation of the EU Equality Directive, in relation to the recruitment and employment of its employees. 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.

About the company

Syneos Health provides end-to-end biopharmaceutical solutions across the clinical-to-commercial spectrum. It helps biopharma companies, healthcare organizations, and investors by offering specialized expertise, insights, and technology-enabled services to move therapies faster to patients. Its offerings include Kinetic, a modern omnichannel customer engagement platform that uses targeting and analytics to coordinate nationwide healthcare communications, and Syneos One, an asset development approach that aligns strategy and execution from early concept through commercialization. The company uses AI and advanced tech to improve performance and reduce risk in drug development and market delivery. Its goal is to be a trusted partner that accelerates therapy development and delivery by combining scientific know-how with integrated, data-driven services.

Company Size

10,001+

Company Stage

IPO

Headquarters

Morrisville, North Carolina

Founded

1985

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Simplify's Take

What believers are saying

KAI partnership on April 30, 2026 expands commercial intelligence for U.S. pharma launches.
Syneos says Causaly cut study-design insight time roughly 50% in 2026.
Databricks reduced source-data review from days to hours, speeding trial interventions.

What critics are saying

March 31, 2026 Kempen discovery keeps securities-fraud claims alive over backlog reporting.
Syneos Italy announced 49 layoffs on March 25, 2026, signaling operating pressure.
A sustained data-integrity finding in Kempen would damage sponsor trust and trigger defections.

What makes Syneos Health unique

Syneos combines clinical development and commercialization under one roof, unlike pure-play CROs.
August 18, 2026 AI stack spans Causaly, Databricks, and Microsoft across workflows.
More than 280 Microsoft Copilot agents give Syneos broad internal automation depth.

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Benefits

Health Insurance
Dental Insurance
Vision Insurance
401(k) Company Match
Employee Stock Purchase Plan
Flexible Work Hours
Paid Vacation
Paid Sick Leave
Remote Work Options

Company News

GlobeNewswire

Oct 20th, 2026

Optum and Syneos Health partner to advance an adaptive Clinical Development model.

Optum and Syneos Health partner to advance an adaptive Clinical Development model. Partnership Will Transform How Clinical Development is Designed and Executed MORRISVILLE, N.C., Oct. 20, 2026 (GLOBE NEWSWIRE) - Syneos Health(R) today announced a partnership with Optum to build a more adaptive and connected model for clinical development, helping biopharmaceutical companies deliver promising therapies to patients sooner. The collaboration will bring together Optum's healthcare industry knowledge, specialized expertise and AI resources with Syneos Health's clinical development expertise, global trial operations and technology solutions. The resulting model is designed to strengthen development strategies and execute more precise, efficient trials by improving recruitment and trial performance, reducing operational complexity and enhancing predictability across development timelines and costs. Under the agreement, Syneos Health and Optum will partner closely in the development of: * Adaptive clinical development planning to enable development teams to simulate trial scenarios, evaluate protocol assumptions, identify possible risks and assess interventions before and during trial implementation. * Patient, site and investigator access to help clinical trial sponsors more easily identify eligible patient populations to expand patient access and optimize locations so trials can begin faster. Syneos Health will be Optum's preferred partner for the development of their site management organization (SMO). * Data, technology and governance infrastructure to responsibly scale these improvements while maintaining rigorous standards for scientific validation, privacy, evidence traceability and human oversight. "Clinical development is at an inflection point. The future belongs to organizations that can connect data, human expertise and AI technology to make better decisions faster," said Costa Panagos, Chief Executive Officer of Syneos Health. "Our collaboration with Optum brings deep healthcare expertise that can help improve trial design and implementation with greater precision and predictability." "Clinical research is one of the most complex and data-intensive activities in healthcare, yet necessary connections are fragmented all too often," said Sandeep Dadlani, Chief Executive Officer of Optum Insight. "By connecting our responsible use of technology and network with Syneos Health's global clinical development capabilities, we can make the health system work better for everyone." This announcement builds on Syneos Health's broader commitment to shape the future of clinical development. As part of its AI ecosystem, the Company continues to invest in technologies and collaborations that enhance decision-making, streamline execution and unlock new value from clinical and real-world data. Recent initiatives have included expanding agentic solutions that connect insights, workflows and expertise across operations. About Syneos Health Syneos Health(R) is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success. We translate unique clinical, commercial and real world insights into outcomes to address modern market realities. We bring together a talented team of professionals with a deep understanding of patient and physician behaviors and market dynamics. Together we share diverse insights, use the latest technologies and apply advanced business practices to speed our customers' delivery of important therapies to patients. Syneos Health is powered by an authentic, inclusive and high-performance culture that cares for colleagues, customers, patients, communities and the environment. About Optum Optum is a leading information and technology-enabled health services business dedicated to helping make the health system work better for everyone. With more than 310,000 people worldwide, Optum delivers intelligent, integrated solutions that help to modernize the health system and improve overall population health. Optum is part of UnitedHealth Group (NYSE: UNH). For more information, visit www.optum.com. Press/Media Contact: Meg Byers Director, External Communications [email protected]

TransportTalk

Aug 31st, 2026

Teletrac Navman appoints Sara Epstein to senior leadership role.

Teletrac Navman appoints Sara Epstein to senior leadership role. Reading Time: 2 mins read Teletrac Navman has appointed Sara Epstein as chief legal and administrative officer as the connected mobility business enters its next phase of growth. Epstein brings more than 20 years of legal and executive leadership experience across sectors including healthcare, life sciences, pharmacy and logistics. She will oversee Teletrac Navman's legal, compliance, data privacy and governance functions, along with People and Culture and Health and Safety. Epstein was previously chief legal officer at pharmacy benefits company RxBenefits and executive vice president and deputy general counsel at Syneos Health, where she led a global team responsible for legal and privacy services. She has also held senior legal roles at Cotiviti Holdings and BlueLinx Holdings and was an associate at international law firm Jones Day. Teletrac Navman President and chief executive Alain Samaha says Epstein's experience will support the company's strategic and growth plans. "Sara brings a powerful combination of legal acumen, business judgment and executive leadership that will help accelerate our strategic initiatives and support our long-term growth," Samaha says. "Her experience leading global teams and navigating complex business environments will be instrumental as we continue to drive innovation, strengthen our customer relationships and execute on our growth ambitions. We're thrilled to welcome her to the team." The appointment follows Teletrac Navman's acquisition by Respida Capital earlier this year and a series of product developments, including the launch of Energy Hub within its TN360 fleet management platform and the company's Electronic Braking Performance Monitoring System. "I'm excited to join Teletrac Navman at such an important time in the company's evolution," Epstein says. "The organisation has a strong foundation, a talented global team, and a clear vision for growth. I look forward to working across the business to support our strategic priorities and contribute to the next chapter of Teletrac Navman's success." Epstein holds a Juris Doctor from Tulane University Law School and a bachelor's degree from Tufts University.

HR TODAY

Aug 26th, 2026

Madhuri Raya joins Syneos Health as Global Head, AI & Engineering and Technology Capability Center.

Madhuri Raya joins Syneos Health as Global Head, AI & Engineering and Technology Capability Center. Hyderabad, Telangana, India, August 2026 - Syneos Health has appointed Madhuri Raya as Global Head, AI & Engineering and Technology Capability Center, strengthening its technology leadership as the organisation accelerates its AI-enabled strategy. In her new mandate, Raya will focus on scaling engineering capabilities behind Syneos Health's growing AI ecosystem and helping translate technology innovation into practical solutions for biopharmaceutical development. Raya brings more than two decades of experience across software engineering, product engineering, cloud-native technologies, AI/ML-enabled solutions and global engineering leadership. She joins Syneos Health after a long tenure with Optum, where she most recently served as Vice President of Software Engineering. During more than eight years with the organisation, she progressed through senior technology leadership positions, including Director of Product Engineering and Senior Director - Product Engineering. Before Optum, Raya spent more than five years with UnitedHealth Group, serving as Engineering Manager and subsequently Senior Engineering Manager. These roles added to her experience in leading engineering organisations within the healthcare ecosystem and managing increasingly complex technology responsibilities. Earlier in her career, Raya spent more than a decade with the Robert Bosch Research and Technology Center. She worked initially as a Software Engineer before progressing to Senior Research Engineer, a position she held for more than seven years. This foundation in software engineering and research, followed by leadership roles across healthcare technology and product engineering, has shaped a career spanning technical innovation and large-scale engineering management. At Syneos Health, Raya joins at a time when the company is expanding the role of AI and technology across its operations. Her mandate will center on strengthening the engineering capabilities supporting this strategy, bringing together AI, engineering and technology delivery to improve agility, precision and intelligence in addressing customer challenges. She is an alumna of the Birla Institute of Technology and Science, Pilani (BITS Pilani). Syneos Health is a fully integrated biopharmaceutical solutions organisation focused on accelerating customer success. The company combines clinical, commercial and real-world insights to help address evolving market needs and support the delivery of therapies to patients. Its professionals bring together knowledge of patient and physician behaviours, market dynamics, technology and advanced business practices. Syneos Health positions technology and cross-functional expertise as important enablers in helping customers advance the development and commercialisation of therapies.

Applied Clinical Trials

Aug 19th, 2026

Syneos Health expands AI ecosystem with three new platform partnerships.

Syneos Health expands AI ecosystem with three new platform partnerships. New collaborations with Causaly, Databricks, and Microsoft anchor a broader push to embed artificial intelligence directly into clinical trial decision-making and operational workflows. "When technology is applied precisely at critical decision points, teams can anticipate risk earlier to accelerate development." Syneos Health has announced the continued expansion of its artificial intelligence (AI) ecosystem, detailing three platform partnerships designed to embed AI into core clinical development workflows.[1] The three partnerships each target a distinct layer of the clinical development stack. Through a new collaboration with Causaly, Syneos is applying agentic, evidence-based scientific reasoning to accelerate protocol strategy development, feasibility planning, and competitive trial intelligence. Causaly's platform surfaces evidence from a proprietary knowledge graph combining biomedical research and commercial insights. According to the company, the integration has reduced the time it takes to derive insights for study strategy and design by approximately 50%. The partnership with Databricks focuses on the data infrastructure layer. By leveraging the Databricks Data and AI Platform, Syneos has developed a near real-time view of clinical operations that reduces the time from source data capture to review-ready insight from days to hours, enabling faster intervention and more efficient trial execution. The Microsoft collaboration, which builds on a relationship that began in 2023, extends AI adoption through productivity and workflow tools. Syneos has used Microsoft Power Apps and other tools to develop more than 280 agents that integrate with Microsoft 365 Copilot to streamline workflows and support faster decision-making across the organization. "When technology is applied precisely at critical decision points, teams can anticipate risk earlier to accelerate development," said Mike Montello, chief digital and information officer at Syneos Health, in a company press release. Together, the three partnerships are designed to create what Syneos Health describes as a unified intelligence environment - connecting operational, clinical, and real-world data across the development lifecycle. The company noted that all capabilities are deployed with human oversight and governance to ensure responsible use in regulated environments. A broader conversation about AI and site readiness. The Syneos announcement reflects a pattern Applied Clinical Trials has been tracking closely: sponsor investment in AI is accelerating, but questions about how that technology reaches sites - and whether it actually fits their workflows - remain unresolved. In a recent with ACT, Liz Beatty, co-founder and chief strategy officer at Inato, addressed that tension directly.[2] Beatty argued that the industry has consistently made the mistake of building technology for sponsors rather than for sites. "We need to stop, and instead think: how can I enable sites to use this technology to become more efficient and effective in clinical trials, which then helps my trial and my company - not the other way around," she said. On where AI is delivering measurable enrollment impact, Beatty pointed to real-time patient data as the most significant shift. Rather than relying on feasibility questionnaires and sponsor-discounted estimates, AI tools can now identify which specific patients at a given site currently meet study criteria. In a chronic obstructive pulmonary disease case study, than those that did not, and 100% of sites using the tool were able to successfully screen and enroll patients. Looking ahead, Beatty pointed to a structural shift she sees gaining momentum: sponsors moving away from trial-by-trial site planning toward program or cross-asset planning, building deeper site partnerships across multiple studies. This represents a dynamic that could meaningfully change how enrollment bottlenecks are addressed before a trial even begins. References

News Break! Middle East

Aug 18th, 2026

Syneos Health advances ai-powered clinical ecosystem to optimize trial performance and speed decision-making.

Syneos Health advances ai-powered clinical ecosystem to optimize trial performance and speed decision-making. Expanding set of partners and proprietary insights strengthens operational performance. MORRISVILLE, N.C., Aug. 18, 2026 (GLOBE NEWSWIRE) - Syneos Health(R), a leading fully integrated biopharmaceutical solutions organization, today announced the continued advancement of its AI ecosystem - a unified, enterprise approach that embeds artificial intelligence (AI) directly into the core of clinical development. By combining deep therapeutic expertise, healthcare professional intelligence and modern AI technologies, Syneos Health is helping sponsors navigate an increasingly complex development landscape. Grounded in decades of clinical and commercial experience, Syneos Health's differentiated AI approach focuses on integrating advanced capabilities into critical decision points across protocol design, feasibility, enrollment planning, site activation, monitoring and operational oversight. This enables teams to anticipate risk earlier, reduce friction across workflows and make faster, more informed decisions that improve study performance. "Our priority is AI that works inside the complexity of clinical trials. By combining advanced AI with a deep understanding of sites, physicians, patients and the operational dynamics that shape trial performance, we're unlocking new opportunities for speed, clarity and quality," said Mike Montello, Chief Digital and Information Officer, Syneos Health. "When technology is applied precisely at critical decision points, teams can anticipate risk earlier to accelerate development." Enterprise AI and Data Platforms Syneos Health is building a future ready ecosystem bringing together capabilities combining scientific expertise, connected data and evidence, and AI-enabled execution. This integrated approach creates a unified intelligence environment that enables faster, more informed decisions across the clinical development lifecycle. * Causaly - Syneos Health's new collaboration with Causaly applies agentic, evidence-based scientific reasoning to enable faster protocol strategy development, feasibility planning and competitive trial intelligence. Built specifically for the life sciences sector, Causaly's Agentic Research surfaces evidence from a proprietary knowledge graph combining biomedical research and commercial insights. By accelerating analysis of complex biomedical literature and emerging data, Syneos Health teams have reduced the time it takes to derive insights for study strategy and design by approximately 50%. * Databricks - Using Databricks enables Syneos Health to create a more powerful, unified intelligence environment that brings together operational, clinical and real-world data to advance modern clinical development. Leveraging the Databricks Data + AI Platform, Syneos Health has developed a continuous, near real-time view of clinical operations that reduces the time from source data capture to review-ready insight from days to hours, enabling faster intervention and more efficient trial execution. * Microsoft - Building on its long-standing collaboration that began in 2023, Syneos Health is driving AI adoption through its integration with Microsoft. Specifically, Syneos Health has used Microsoft Power Apps and other tools to develop more than 280 agents that integrate with Microsoft 365 Copilot to improve productivity, streamline workflows and support faster, more confident decision-making across the company. Complementing these foundational capabilities are frontier agentic AI solutions and proprietary Syneos Health insights embedded directly within clinical workflows. Together, they help improve predictability, reduce operational complexity, and drive more precise, scalable trial performance. These capabilities are deployed with strong human oversight and governance, ensuring responsible use in regulated environments. "What differentiates Syneos Health is our ability to redesign how clinical development decisions are made through the combination of scientific intelligence, connected evidence, operational expertise and AI-enabled execution across the development lifecycle," said Michael Brooks, Chief Operating Officer, Syneos Health. "By grounding AI in deep clinical expertise and real-world experience, we help sponsors reduce complexity, make better-informed decisions and ultimately deliver better outcomes for patients." About Syneos Health Syneos Health(R) is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success. News Break Middle East translate unique clinical, commercial and real world insights into outcomes to address modern market realities. News Break Middle East bring together a talented team of professionals with a deep understanding of patient and physician behaviors and market dynamics. Together News Break Middle East share diverse insights, use the latest technologies and apply advanced business practices to speed its customers' delivery of important therapies to patients. Syneos Health is powered by an authentic, inclusive and high-performance culture that cares for colleagues, customers, patients, communities and the environment. Press/Media Contact: Meg Byers Director, External Communications [email protected] Legal Disclaimer: EIN Presswire provides this news content "as is" without warranty of any kind. News Break Middle East do not accept any responsibility or liability for the accuracy, content, images, videos, licenses, completeness, legality, or reliability of the information contained in this article. If you have any complaints or copyright issues related to this article, kindly contact the author above.

Syneos Health

Global Clinical Trial Manager 2 or Senior

About the job