Clinical Trial Coordinator/ Senior Project Specialist (Sponsor Dedicated/ US Remote)

Clinical Trial Coordinator/ Senior Project Specialist (Sponsor Dedicated/ US Remote)

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

Clinical Trial Coordinator /Senior Project Specialist  (Sponsor Dedicated/ Remote- US only)

Preference for US East Coast Candidates

Are you a clinical research professional who enjoys being at the center of study operations, driving organization, coordinating stakeholders, and ensuring clinical trials run efficiently? Do you thrive in an environment where you are empowered to take ownership, solve problems independently, and collaborate across multiple functions to deliver successful outcomes?

This opportunity supports a dedicated Sponsor clinical trial team focused on the oversight and execution of global clinical studies. The team is seeking an experienced Clinical Trial Coordinator (Senior Project Specialist) who combines strong operational execution with excellent organizational and communication skills.

Success in this role requires a proactive, detail-oriented professional who can manage multiple priorities, maintain oversight of critical study activities, and effectively partner with vendors, CROs, and cross-functional stakeholders. This position offers significant exposure to study management activities and vendor oversight while providing a strong foundation for future growth into project management and clinical operations leadership roles.

The ideal candidate has experience supporting clinical trial operations, working within CTMS and TMF systems, managing study documentation and metrics, and coordinating activities across study teams. Experience with Veeva applications and vendor oversight activities is highly preferred.

While candidates across the United States will be considered, preference will be given to candidates located in the Eastern Time Zone.

THE ROLE

As a Clinical Trial Coordinator (Senior Project Specialist), you will play a critical role in supporting the operational execution of clinical studies throughout the trial lifecycle.

You will partner closely with Clinical Operations Project Leads, study teams, vendors, and CRO partners to ensure study deliverables, timelines, reporting, documentation, and operational activities are completed accurately and efficiently.

This role requires an individual who is highly organized, capable of managing competing priorities, and comfortable operating independently within a dynamic Sponsor-dedicated environment.

WHAT YOU WILL DO

• Support clinical trial operations from study start-up through closeout activities.

• Maintain and track study documentation, Trial Master File (TMF) records, KPIs, enrollment metrics, protocol deviations, adverse events, site supplies, regulatory documents, and other study-related information.

• Perform accurate Clinical Trial Management System (CTMS) data entry, maintenance, and reporting activities.

• Maintain study personnel directories, training records, and system access management.

• Support TMF quality review activities and contribute to inspection readiness efforts.

• Coordinate and facilitate study team meetings, vendor meetings, and cross-functional working sessions.

• Prepare meeting agendas, meeting minutes, action items, and follow-up documentation.

• Track action items and drive accountability across study stakeholders to ensure timely completion.

• Support vendor oversight activities, including status reporting, issue tracking, and escalation management.

• Develop and maintain study trackers, KPI dashboards, and operational reports.

• Compile and analyze study data from multiple sources to support ongoing study oversight and decision-making.

• Support financial and administrative activities, including invoicing, investigator payments, patient reimbursement processes, and forecasting activities.

• Assist with audit and inspection readiness activities and support responses to quality findings.

• Archive study documentation and ensure compliance with organizational policies and regulatory requirements.

• Provide operational support to Clinical Operations Project Leads and other study team members as needed.

• Serve as a point of contact for study-related operational activities when delegated by study leadership.

• Mentor and support junior team members when appropriate.

WHO YOU ARE

Required Qualifications

• Bachelor's degree or equivalent combination of education and experience in Life Sciences, Nursing, Pharmacy, Medicine, Public Health, or a related field is preferred .

• Clinical research experience supporting clinical trial operations within a pharmaceutical, biotechnology, CRO, or Sponsor environment.

• Understanding of clinical drug development processes and clinical trial operations.

• Experience working with Clinical Trial Management Systems (CTMS).

• Strong experience using Veeva applications.

• Knowledge of Trial Master File (TMF) processes and inspection readiness requirements.

• Strong knowledge of Good Clinical Practice (GCP), ICH Guidelines, and applicable regulatory requirements.

• Advanced proficiency with Microsoft Office applications, particularly Excel.

• Strong organizational and multitasking abilities with demonstrated success managing competing priorities.

• Excellent verbal and written communication skills.

• Ability to work independently with minimal day-to-day supervision.

• Strong problem-solving skills and attention to detail.

Preferred Qualifications

• Experience supporting Sponsor-dedicated clinical trial programs.

• Experience with vendor oversight and CRO management activities.

• Experience supporting global clinical studies.

• Experience navigating and compiling intel from operational dashboards for metrics and KPI reporting.

• Experience supporting Phase II and Phase III clinical trials.

• Experience coordinating Study Management Team (SMT) meetings and cross-functional study activities.

• Experience with investigator payments, invoicing processes, and study financial and insurance tracking.

• Therapeutic area experience within complex clinical development programs.

WHO WILL BE SUCCESSFUL

The ideal candidate:

• Has strong experience supporting day-to-day clinical trial operations.

• Demonstrates advanced proficiency with Veeva and CTMS/vendor systems.

• Is highly organized and capable of managing multiple priorities simultaneously.

• Takes ownership of deliverables and follows through on action items with minimal oversight.

• Communicates effectively with vendors, CRO partners, study teams, and leadership.

• Enjoys problem solving and proactively identifies opportunities for improvement.

• Is comfortable working in a dynamic environment that requires flexibility and adaptability.

• Maintains a strong focus on quality, compliance, and operational excellence.

• Builds collaborative relationships across cross-functional teams.

• Thrives in a Sponsor-dedicated setting where accountability and initiative are highly valued.

WHAT MAKES THIS OPPORTUNITY DIFFERENT

• Join a dedicated Sponsor team with direct visibility into study operations and decision-making.

• Gain meaningful exposure to vendor oversight and clinical trial management activities.

• Build experience that supports future growth into Project Manager and Clinical Operations leadership roles.

• Work closely with cross-functional stakeholders throughout the clinical trial lifecycle.

• Contribute to high-profile clinical development programs that impact patient outcomes.

• Operate within a collaborative team environment that values initiative, adaptability, and continuous learning.

• Enjoy the flexibility of a fully remote work environment while remaining closely connected to Sponsor leadership and study teams.

• Opportunity to expand your operational expertise while developing project management capabilities in a Sponsor-dedicated setting.

At  Syneos Health, we believe in providing an environment and culture in which Our People can thrive, develop and advance. We reward and recognize our people by providing valuable benefits and a quality-of-life balance. The benefits for this position may include a company car or car allowance, Health benefits to include Medical, Dental and Vision, Company match 401k, eligibility to participate in Employee Stock Purchase Plan, Eligibility to earn commissions/bonus based on company and individual performance, and flexible paid time off (PTO) and sick time.  Because certain states and municipalities have regulated paid sick time requirements, eligibility for paid sick time may vary depending on where you work. Syneos complies with all applicable federal, state, and municipal paid sick time requirements.

Salary Range:

$47,000.00 - $79,900.00

The base salary range represents the anticipated low and high of the Syneos Health range for this position. Actual salary will vary based on various factors such as the candidate’s qualifications, skills, competencies, and proficiency for the role.

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.

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.

Summary

The Senior Project Specialist is responsible for maintaining and coordinating the logistical aspects of clinical projects and provides overall support to functional leads to ensure the successful completion of project deliverables. The Senior Project Specialist supports the Project Lead (PL) to ensure the contracted services and expectations of assigned projects are carried out by the project teams in accordance with executed contracts and the customers’ requirements. Operates independently, with minimal day-to-day oversight, and may co-ordinate the activities of Project Specialists.