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.

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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