Experienced Clinical Trial Manager - Full-Service

Experienced Clinical Trial Manager - Full-Service

Location: Morrisville, NC, United States Job ID: 25105905-OTHLOC-1500-2DMA-2DR

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Job Description:

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 brings the customer and the patient to the center of everything that we do. We are continuously looking for ways to simplify and streamline our work to not only make Syneos Health easier to work with but to make us easier to work for.

Whether you join us in a Functional Service Provider partnership or a Full-Service environment, you will collaborate with passionate problem solvers innovating as a team to help our customers achieve their goals. We are agile and driven to accelerate the delivery of therapies because we are passionate to change lives.

Discover What Our 29,000 Employees Already Know: Work here matters everywhere. We work hard and smart all in the name of getting much-needed therapies to those who need them most. A career with Syneos Health means your everyday work improves patients lives around the world.

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, including patient recruitment, investigator payments, or other related activities.
• Reviews the study scope of work, budget, and protocol content, ensuring the clinical project team is aware of contractual obligations and parameters.
• Employs strategic thinking and problem-solving skills to propose and implement risk mitigations.
• Participates and presents in key meetings, such as Kick Off Meetings.
• 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.
• Collaborates with other functional leaders to coordinate delivery handoffs and meet expected study milestones.
• 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.
• Coordinates initial and ongoing training to the study team regarding protocol specifics, Case Report Form (CRF) completion, dashboards, Sponsor Standard Operating Procedures (SOPs), clinical plans, and guidelines.
• Oversees resourcing allocations for CRAs and Central Monitors, site assignments, and study team members, conduct, and identifies risks to delivery or quality.
• Reviews project oversight dashboards and other clinical trial systems to oversee site and patient activities, study team conduct, and ensure data has been updated to reflect timely execution of all operational aspects.

Qualifications:

• Bachelors 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 (GCP), ICH Guidelines, and other applicable regulatory requirements.
• Must demonstrate good computer skills.
• 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.

Benefits:

• Company car or car allowance
• Health benefits, including medical, dental, and vision
• Company match 401(k) eligibility
• Eligibility to participate in Employee Stock Purchase Plan
• Eligibility to earn commissions and bonuses based on company and individual performance
• Flexible paid time off (PTO) and sick time
• Salary range: $114,000 - $210,900

Salary Range: $114,000 - $210,900

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.

Why Work Here: We work hard and smart all in the name of getting much-needed therapies to those who need them most. A career with Syneos Health means your everyday work improves patients lives around the world.

Join Our Talent Network: Click here to enable personalized experience. Share this job. Apply inside Syneos Health.

Our Values: Who We Are Our Solutions Diversity, Equity, and Inclusion Why Work Here Discover what our more than 29,000 employees already know: work here matters everywhere.

Careers: We take our work seriously. Each day, youll contribute to improving patients lives around the world by shortening the distance from lab to life. Its powerful and fulfilling work, and you can be proud of it.

Get in Touch: Syneos Health Nasdaq: SYNH 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.