[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.ResponsibilitiesSupport Clinical Operations with GCP guidance and best industry practicesLead 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 requirementsContribute to the management of business and compliance metrics to assess and continuously improve oversight and inspection readiness throughout the clinical trial lifecycleSupport Clinical Operations Inspection Readiness activitiesContribute to Clinical Operations training programs to deliver company standards, GCP, and regulatory requirementsPartner cross-functionally and with QA on remediation plans and continuous improvement of GCP systems, investigations, CAPAs, and audit responsesCommunicate deliverable status/issues, and problem-solve to ensure functional goals are metUse all available tools to track, oversee, and communicate on project status to all key stakeholdersParticipate in other Clinical Operations Compliance & Training activities as assignedSkillsRN, Bachelor's, or Master's degree in biological sciences or a health-related field required10+ 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 experienceStrong working knowledge of FDA Regulations, GCP, and ICH Guidelines, and current industry practicesDemonstrated experience successfully developing and authoring Clinical and cross-functional SOPs, ensuring compliance with GCP and regulatory requirementsExperience with the development and monitoring of oversight activitiesThrives 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 environmentBe solution-oriented by anticipating obstacles and difficulties, and proactively providing risk assessment and mitigation strategies to achieve project goalsExcellent written/verbal communication and interpersonal skillsHigh sense of priority and commitment to excellence in the successful execution of deliverablesAbility 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 teamDemonstrate proficiency in Microsoft Office Suite (Outlook, MS Word, Excel, PowerPoint); MS Project and/or Smartsheet a plusTravel may be required (~25%)Oncology experience, early and/or late stageKnowledge and/or familiarity with Ex-US region(s) regulations and requirementsBenefitsW2 ContractRemote Role - PSTTravel 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.Company OverviewBayside Solutions is a staffing and recruiting company offering IT, telecom, and scientific staffing services. It was founded in 2001, and is headquartered in San Ramon, California, USA, with a workforce of 51-200 employees. Its website is https://baysidesolutions.com/.