Clinical Trial Manager Ii (Client Base)

6+ years

Not Disclosed

Remote

10 Dec. 22, 2024

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

Position: Clinical Trial Manager II (Client Base)
Company: Syneos Health®

Role Overview:
Syneos Health, a leader in biopharmaceutical solutions, is seeking a Clinical Trial Manager II to oversee clinical trial management activities. This role ensures patient safety, compliance with regulations, and data integrity throughout the trial lifecycle. The ideal candidate will bring expertise in site management, monitoring, and project leadership within a dynamic global environment.

Key Responsibilities:

Oversee site management, clinical monitoring, and central monitoring deliverables, focusing on patient safety, compliance, and data integrity.
Manage site interactions from activation to closeout, including patient recruitment and investigator payments.
Identify risks using the Risk Assessment and Categorization Tool (RACT) and implement mitigation strategies.
Ensure compliance with the scope of work, budget, and protocol while communicating any risks or out-of-scope activities to project managers.
Act as an escalation point for site staff communications and support conflict resolution when required.
Collaborate with functional leaders to coordinate delivery handoffs, meet milestones, and provide feedback on functional plans.
Develop and maintain clinical study tools, templates, and monitoring plans.
Train study teams on protocol specifics, case report forms, sponsor SOPs, and timelines.
Ensure the quality and compliance of monitoring and site management deliverables, maintaining visibility through dashboards and systems.
Review and ensure documentation quality in CTMS and related systems.
Actively engage with clients, project management, and functional departments to provide updates, manage risks, and deliver solutions.
Support inspection readiness and execute corrective action plans as needed.
Provide feedback on staff performance and assist in achieving data cut and lock deadlines.

Qualifications:

Bachelor’s degree or RN in a related field, or equivalent education and experience.
Minimum 6+ years of experience, with at least 3 years in project management.
Expertise in site management, monitoring, and risk-based monitoring approaches.
Understanding of clinical trial financial principles and budget management.
Knowledge of Good Clinical Practice (GCP), ICH Guidelines, and applicable regulatory requirements.
Strong computer, communication, presentation, and interpersonal skills.
Proven conflict resolution and problem-solving abilities with a risk management focus.
Ability to lead and align teams in achieving milestones.
Experience in an international work environment is preferred.
Moderate travel (approximately 20%) required.

Why Join Syneos Health?
At Syneos Health, we empower our employees to thrive by offering career development, training, peer recognition, and a supportive environment. Our Total Self culture ensures you can authentically be yourself while making an impact. Collaborate with a diverse team to advance healthcare and deliver life-changing therapies to patients worldwide.

Additional Information:
Tasks and responsibilities may vary, and the company reserves the right to make changes as needed. Syneos Health is committed to diversity, equality, and providing reasonable accommodations under applicable laws.

Join Syneos Health and discover a workplace where "Work Here Matters Everywhere."

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Clinical Trial Manager Ii (Client Base)

Job Description

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