Clinical Trial Manager Job at Bayside Solutions, San Mateo County, CA

L0RFL0JsMnFCWm0yYzRRaGpnT1ZneW83Nnc9PQ==
  • Bayside Solutions
  • San Mateo County, CA

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.

Bayside Solutions, Inc. may collect your personal information during the position application process. Please reference Bayside Solutions, Inc.'s CCPA Privacy Policy at

Job Tags

Contract work, Interim role,

Similar Jobs

Kelly

Industrial Maintenance Technician Job at Kelly

 ...Kelly Services is partnering with Signode to hire Night Shift Maintenance Technicians for their Kankakee, IL facility . This location operates extrusion lines producing PVC spacers for steel coils and slip sheets for meat manufacturing. Youll be part of a... 

Interim HealthCare RMC

Director of Pediatric Services RN Job at Interim HealthCare RMC

 ...Title: Director of Pediatric Services (RN)- Morgantown, WV We are seeking a Director of Pediatric Services RN that will be responsible for efficient and effective delivery of all clinical and paraprofessional services in accordance with the core values of Interim... 

Burnett Specialists Staffing | Recruiting

Customer Service Representative Job at Burnett Specialists Staffing | Recruiting

 ...Customer Service Representative Position Overview: The Customer Account Specialist is responsible for managing the full order lifecycle?from entry through delivery?while ensuring an exceptional customer experience. This role requires strong attention to detail, communication... 

PDQ Door

Sales Representative Job at PDQ Door

 ...career at PDQ Door Company! We have an immediate need for a Sales Representative at our West Bath, ME location. PDQ Door Company is...  ...package to our team members including: ~ Competitive salary ~ Medical, dental, and vision insurance with multiple plan options ~... 

US Tech Solutions

POS Tester Job at US Tech Solutions

 ...Location: Columbus, OH Duration: 06 Months Contract Job Description: ~ The Tester will be part of the Testing Center of Excellence. This position will be part of a high performing quality assurance team participating in the delivery of quality software. This role...