Senior Clinical Trial Manager
W2 Contract
Salary Range: $166,400 - $187,200 per year
Location: Redwood City, CA - Hybrid or Remote PST
Job Summary:
As a Senior Clinical Trial Manager (CTM), you will act as a central contact for the clinical study team(s) and assist with the execution and management of clinical trials.
Duties and Responsibilities:
- Identify, engage, and manage the activities of contract research organizations (CROs) and other clinical trial vendors (e.g., Interactive Response Technology (IRT), imaging vendor, central labs, etc.), as well as serve as a liaison between internal team members, investigative sites, and CROs.
- Support the study lead in managing clinical study timelines and budgets by utilizing appropriate project management tools, identifying and selecting vendors, managing vendor contracts, and ensuring budgets are within department guidelines.
- Co-lead team meetings and collaborate with cross-functional groups within the clinical study team (e.g., Clinical Data Science, Clinical Development, Pharmacokinetics, Regulatory, etc.) to achieve clinical trial goals.
- Follow up and follow through on team action items and identify, escalate, and resolve issues as needed.
- Assess adequacy and feasibility of potential clinical investigators and sites, including qualification of investigators, evaluation of facilities, personnel, patient referral base, and adherence to GCP.
- 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.
- Provide support, mentorship, guidance, and direction to Clinical Trial Assistants (CTAs) and Clinical Trial Management Associates (CTMAs), as appropriate.
- Actively contribute to the development of internal business documents (e.g., SOPs, Clinical Study Reports, Investigational New Drugs (INDs), New Drug Applications (NDAs), and other Clinical, Regulatory, and Safety documents) with minimal supervision.
- Support other Clinical Operations activities as appropriate.
Requirements and Qualifications:
- RN or Bachelor's degree in biological sciences or health-related field required
- 5-7+ years of direct experience and/or relevant experience in the pharmaceutical or biotech industry, preferably in Clinical Operations or Clinical Research-related experience.
- Strong working knowledge of FDA Regulations, ICH Guidelines, and GCP
- Experience in the selection of CROs/vendors and management of external resources.
- Thrives in a collaborative team setting that demonstrates the flexibility required to maintain a fast pace and is driven by a desire to deploy innovative approaches and technologies in a high-energy environment.
- Excellent written/verbal communication and interpersonal skills.
- High sense of priority and commitment to excellence in the successful execution of deliverables
- Ability to analyze operational data, perform with an emphasis on quality and timeliness, and multi-task, prioritize tasks, anticipate challenges, and execute goals as a member of an interdisciplinary team.
- Demonstrate proficiency in Microsoft Office Suite (Outlook, MS Word, Excel, PowerPoint); MS Project and/or Smartsheet a plus.
- Travel may be required ( 15%).
Preferred Qualifications:
- Familiarity working with vendor systems/portals (e.g., eTMF, EDC, IRT, CTMS)
- Oncology experience, early and/or late stage, is strongly preferred.
- Knowledge and/or familiarity with EMEA/APAC region(s) clinical trial operations.
Desired Skills and Experience
Clinical Operations, Clinical Research, FDA Regulations, ICH Guidelines, cGCP, vendor management, Microsoft Office, eTMF, EDC, IRT, CTMS, 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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