[Remote] Senior Clinical Program Manager
Note: The job is a remote job and is open to candidates in USA. Bayside Solutions is seeking a Senior Clinical Program Manager to play a vital role in Clinical Operations, Compliance, and Training functions. The role focuses on developing and improving GCP infrastructure, ensuring compliance with industry standards, and supporting clinical operations throughout the trial lifecycle.
Responsibilities
- Support Clinical Operations with GCP guidance and best industry practices
- Lead or support the development and continuous improvement of Clinical Policies/ SOPs/ WIs/ Templates/etc in compliance with International Conference on Harmonization (ICH) Guidelines, Good Clinical Practices (GCP), and regulatory requirements
- Contribute to the management of business and compliance metrics to assess and continuously improve oversight and inspection readiness throughout the clinical trial lifecycle
- Support Clinical Operations Inspection Readiness activities
- Contribute to Clinical Operations training programs to deliver company standards, GCP, and regulatory requirements
- Partner cross-functionally and with QA on remediation plans and continuous improvement of GCP systems, investigations, CAPAs, and audit responses
- Communicate deliverable status/issues, and problem-solve to ensure functional goals are met
- Use all available tools to track, oversee, and communicate on project status to all key stakeholders
- Participate in other Clinical Operations Compliance & Training activities as assigned
Skills
- RN, Bachelor's, or Master's degree in biological sciences or a health-related field required
- 10+ years (Sr. CPM) direct Clinical Operations and/or Clinical Compliance and/or Clinical Quality Assurance experience in the pharmaceutical or biotech industry, or Clinical Research-related experience
- Strong working knowledge of FDA Regulations, GCP, and ICH Guidelines, and current industry practices
- Demonstrated experience successfully developing and authoring Clinical and cross-functional SOPs, ensuring compliance with GCP and regulatory requirements
- Experience with the development and monitoring of oversight activities
- 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
- Be solution-oriented by anticipating obstacles and difficulties, and proactively providing risk assessment and mitigation strategies to achieve project goals
- 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, contribute with a mind on quality, timeliness, and fiscal responsibility, make and drive decisions, multi-task, prioritize tasks, anticipate challenges, and execute on 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 (~25%)
- Oncology experience, early and/or late stage
- Knowledge and/or familiarity with Ex-US region(s) regulations and requirements
Benefits
- W2 Contract
- Remote Role - PST
- Travel may be required (~25%)
- Bayside Solutions, Inc. may collect your personal information during the position application process. Please reference Bayside Solutions, Inc.'s CCPA Privacy Policy at www.baysidesolutions.com.
- Bayside Solutions, Inc. may collect your personal information during the position application process. Please reference Bayside Solutions, Inc.'s CCPA Privacy Policy at www.baysidesolutions.com.
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