Experienced Clinical Trial Manager - Full-Service

Experienced Clinical Trial Manager - Full-Service

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

Not ready to apply? Join our Talent Network

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 across 110 countries already know. WORK HERE MATTERS EVERYWHERE

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. 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.
• 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.
• 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, such as Study Start Up, Patient Recruitment, and Data Management, 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, 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.
• Reviews the project oversight dashboards and other clinical trial systems, such as 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.
• Documented 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.
• 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.
• Develops and supports 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 or may coordinate clinical activities for a team of CTMs across a portfolio of projects.
• May coach and mentor CTMs regarding functional clinical delivery, evaluation of project risks, and action implementation.

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
• Syneos complies with all applicable federal, state, and municipal paid sick time requirements

Salary Range:

• $114,000.00 - $210,900.00

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:

• Take the initiative and challenge the status quo with us in a highly competitive and ever-changing environment.
• Learn more about Syneos Health: 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 and 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:

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.

Impact and Contribution:

• Includes executives, as well as managers, supervisors, and team leads providing strategic vision and/or tactical direction across a discipline and/or broader organization.
• The majority of time is spent overseeing their area of responsibility, planning, prioritizing, and/or directing the responsibilities of employees.
• Goals are achieved through management of process, policy, and performance of direct and/or indirect reports.

How to Apply:

• Not ready to apply? Join our Talent Network
• Click here to enable personalized experience
• Share this job

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 across 110 countries already know. WORK HERE MAT