Clinical Trial Manager Ii

2+ years

Not Disclosed

United States

10 April 22, 2025

Job Description

Job Type: Full Time Education: B.Sc./M.Sc./B.Pharm/M.Pharm/Life science Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

Clinical Trial Manager II

Updated:

April 14, 2025

Location:

North America - United States

Job ID:

25003210

About Syneos Health:

Syneos Health® is a leading fully integrated biopharmaceutical solutions organization designed to accelerate customer success. We translate clinical, medical affairs, and commercial insights into actionable outcomes to meet evolving market needs.
Our Clinical Development model places the customer and the patient at the center of everything we do, focusing on streamlining and simplifying processes to ensure an exceptional partnership and working experience.
With 29,000 employees across 110 countries, Syneos Health offers an opportunity where Work Here Matters Everywhere.

Why Join Syneos Health:

Strong focus on career development and progression.
Supportive, engaged line management and therapeutic area training.
Peer recognition and total rewards program.
Total Self culture — promoting authenticity and belonging.
Diverse, inclusive, and globally unified environment.

Job Responsibilities:

Oversee site management, clinical monitoring, and central monitoring with a focus on patient safety, compliance, and data integrity.
Manage site activities post-activation, including patient recruitment and investigator payments.
Identify protocol execution risks and develop risk mitigations using the Risk Assessment and Categorization Tool (RACT).
Review study scope of work, budget, and protocol to ensure team alignment with contractual obligations.
Utilize operational data and experience to identify and escalate risks to project timelines, quality, and budgets.
Lead strategic risk mitigation planning and present solutions.
Represent the clinical team during Kick Off Meetings and serve as an escalation point for site communications.
Collaborate with Study Start-Up, Patient Recruitment, and Data Management for milestone achievements such as site activation and database lock.
Develop and maintain clinical study tools and ensure proper system setup (e.g., CTMS, EDC, TMF).
Coordinate initial and ongoing study-specific training for the team.
Oversee CRA and Central Monitor resource allocations and site assignments.
Ensure high-quality clinical monitoring and site management deliverables by using tracking tools and approved systems.
Review monitoring documentation for protocol/GCP compliance, patient safety, and data integrity risks.
Provide status updates to clients and project leadership, offering solutions to operational challenges.
Support cross-functional collaboration to ensure trial compliance across departments like Data Management and QA.
Maintain Inspection Readiness for clinical trial management activities.
Oversee staff performance, including providing feedback on strengths and areas for development.
May be assigned to larger, more complex trials.

Qualifications:

Bachelor’s degree or RN in a related field or an equivalent combination of education, training, and experience.
Proven leadership and team alignment capability to achieve project milestones.
Experience in an international clinical trial environment.
Expertise in site management and monitoring (clinical or central).
Preferred experience with risk-based monitoring.
Strong understanding of clinical trial financial principles and budget management.
Good knowledge of Good Clinical Practice (GCP)/ICH guidelines and applicable regulations.
Strong computer, communication, presentation, and interpersonal skills.
Effective conflict resolution and problem-solving skills.
Critical thinking abilities for identifying issues and proposing solutions.
Willingness to travel approximately 20%.

About Syneos Health Achievements:

Supported 94% of all Novel FDA-Approved Drugs and 95% of EMA Authorized Products over the last 5 years.
Worked across 73,000 sites and with over 675,000+ trial patients globally.

Additional Information:

Tasks and responsibilities are not exhaustive and may change at the Company’s discretion.
Equivalent experience, skills, and/or education will be considered.
Compliance with all applicable equal employment opportunity laws is ensured, including ADA accommodations where appropriate.

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Clinical Trial Manager Ii

Job Description

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