Experienced Clinical Trial Manager - Full-Service

Experienced Clinical Trial Manager - Full-Service

Location: Morrisville, NC, United States Job ID: 25105905-OTHLOC-1500-2DAK-2DR Not ready to apply: Join our Talent Network

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Experienced Clinical Trial Manager - Full-Service

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Location: Morrisville, NC, United States Job ID: 25105905-OTHLOC-1500-2DAK-2DR Not ready to apply: Join our Talent Network

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, youll 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 across 110 countries 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 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.

We are continuously building the company we all want to work for and our customers want to work with. Why Because when we bring together diversity of thoughts, backgrounds, cultures, and perspectives - we are able to create a place where everyone feels like they belong.

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.
• May be responsible for identifying 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, CeMs, 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 that 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.
• Collaborates with other functional leaders, such as Study Start Up, Patient Recruitment, and Data Management, to coordinate delivery handoffs and meet expected study milestones.
• 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 specifics, 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 maintains 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, IWS, 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 of ongoing compliance and delivery according to the stated monitoring strategy, CMPSMP, 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.
• Documents 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.

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.
• Demonstrates critical thinking to determine the cause and appropriate solution in the identification of issues.
• Moderate travel may be required, approximately 20%.

Benefits

• Company car or car allowance
• Health benefits, including Medical, Dental, and Vision
• Company match 401k 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
• Syne