Job Description

Clinical Trial Manager

W2 Contract-to-Hire

Salary Range: $156,000 - $166,400 per year

Location: Redwood City, CA - Hybrid Role

Job Summary:

As a Clinical Trial Manager, you will independently manage one or more Phase 1-3 studies or complex components of larger trials with cross-functional oversight and vendor management.

Duties and Responsibilities:

• Apply advanced expertise and exercise considerable latitude to determine objectives and to develop effective solutions to guide the successful completion of complex assignments under limited supervision.
• Participate in the Clinical Study Execution Team (CSET) discussion and may lead aspects of the meeting agenda regarding vendors, study metrics, etc.
• Drive site activation and document readiness activities; analyze enrollment and operational metrics, supporting the study lead in decision-making.
• Participate and sometimes lead meetings internally and externally with CROs, vendors, and multi-functional teams with minimal supervision.
• Lead TMF reconciliation and inspection readiness activities.
• Support the review of study documents such as protocols, ICFs, CRFs, monitoring plans, etc.
• Lead department process improvement initiatives.
• Participate in CROs/vendor trainings as they relate to a limited aspect of study requirements.
• Manage the CRO and some ancillary vendors and ensure deliverables.
• May participate in the interview process for similar or junior roles within Clinical Operations.
• Mentor and support Clinical Trial Assistants (CTAs) and Clinical Trial Management Associates (CTMAs).
• Follow up and follow through on team action items and identify, escalate, and resolve issues as needed.
• Review and identify trends when performing routine data surveillance of data listings, and support in preparing interim and final Clinical Study Reports and resolving data discrepancies.
• Support other Clinical Operations activities as appropriate.

Requirements and Qualifications:

• BS, BA, or RN in a relevant scientific discipline.
• 5-7+ years of relevant experience in the pharmaceutical or biotech industry, preferably in Clinical Operations or Clinical Research-related experience.
• Advanced knowledge of FDA and EMA Regulations, ICH Guidelines, GCP, and familiarity with standard clinical operating procedures.
• Strong communication and coordination skills; global trial experience and strong operational judgement.
• Proactive contributor to trial execution and issue resolution, with strong ownership of responsibilities for complex studies with multiple sites.
• High sense of priority and commitment to excellence in successfully executing deliverables.
• Ability to analyze operational data, perform with an emphasis on quality, timeliness, and multitasking, prioritize tasks, anticipate challenges, and execute on goals as a member of an interdisciplinary team.
• Travel may be required (~15%).

Preferred Qualifications:

• Decision-making skills
• Has familiarity working with vendor systems/portals (eTMF, EDC, IRT, CTMS).
• Oncology experience, early and/or late stage, strongly preferred.

Desired Skills and Experience

Clinical Operations, Clinical Research, FDA and EMA Regulations, ICH Guidelines, GCP,SOP, eTMF, EDC, IRT, CTMS, CRO management, Oncology, travel

Bayside Solutions, Inc. is not able to sponsor any candidates at this time. Additionally, candidates for this position must qualify as a W2 candidate.

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