Experienced Clinical Trial Manager - Full-Service

Experienced Clinical Trial Manager - Full-Service

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

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

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, and flexible paid time off.

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 and ensures 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 the 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 required visits, calls, duration, and frequency according to plan.

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.

Salary Range: $114,000.00 - $210,900.00

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 our Total Self culture - where you can authentically be yourself. Our Total Self culture is what unites us globally, and we are dedicated to taking care of our people.

Impact and Contribution:

Roles within the Clinical Trial Management job family are responsible for all aspects of the development, coordination, and implementation of Phase 1 clinical research studies at the organizations facilities. Collaborates with the principal investigator, liaisons between research subjects, client teams, investigators, and clinic operations teams, and plans logistics and resource usage. Tracks study progress in alignment with project milestones, client deliverables, and budget and follows applicable regulations globally and by region.

Benefits:

• Company car or car allowance
• Health benefits to include medical, dental, and vision
• Company match 401k eligibility
• Flexible paid time off
• PTO and sick time
• Employee Stock Purchase Plan
• Commissions and bonuses based on company and individual performance
• Total rewards program

How to Apply:

Not ready to apply? Join our Talent Network.

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About Syneos Health:

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. Together, we share insights, use the latest technologies, and apply advanced business practices to speed our customers delivery of important therapies to patients.

Contact Us:

Get in touch with Syneos Health to learn more about our company and career opportunities.

Syneos Health:

Nasdaq: SYNH A leading fully integrated biopharmaceutical solutions organization built to accelerate customer success.

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