Bayside Solutions · 4 hours ago
Clinical Program Manager (CPM)
San Mateo County, CA
Contract
Hybrid
Senior Level, Lead/Staff
$177K/yr - $198K/yr
8+ years expBayside Solutions is seeking a Clinical Program Manager (CPM) to drive operational strategy across multiple trials within entire clinical programs. The role involves overseeing trial execution, collaborating with cross-functional partners, and ensuring compliance with regulations.
Telecom & CommunicationsHuman ResourcesAppsInformation TechnologyStaffing AgencyTelecommunicationsVirtual Reality
No H1B
Responsibilities
Provide expert thought leadership at the discipline level on highly complex and business-critical assignments and begin to develop new ideas
Lead the Clinical Study Execution Team (CSET) meetings and ensure trial timelines are met
Develop trial execution strategy and timelines across study(ies)
Participate in multiple departments or interdepartmental strategic initiatives under limited supervision as it relates to study-specific initiatives
May serve as a resource for others with regard to a specific study trial
Maintain audit/inspection readiness and oversee TMF compliance
Collaborate with cross-functional partners in drafting study documents such as protocols, ICFs, CRFs, monitoring plans, etc
Drive consistency in processes and tools across studies
Contribute to the development of RFPs and participate in the selection of CROs/vendors
May be asked to train CROs, vendors, investigators, and study coordinators, as well as cross-functional partners on study requirements
Oversee CROs, vendors, and key external partners to ensure study delivery
Make recommendations for the development of the study-level budget
Participate in the recruiting and hiring process
Mentor and train Clinical Trial Managers (CTMs), Clinical Trial Management Associates (CTMAs), and Clinical Trial Assistants (CTAs)
Conduct risk management, contingency, and scenario planning
Participate in other Clinical Operations activities as appropriate
Qualification
Required
BS, BA, or RN in a relevant scientific discipline
8+ years of relevant experience in the pharmaceutical or biotech industry, preferably in Clinical Operations or Clinical Research-related experience
Expert knowledge of FDA and EMA Regulations, ICH Guidelines, GCP, and familiarity with standard clinical operating procedures
High-level cross-functional collaboration; strategic thinking across trials and functions
Strategic thinking across clinical trials and functions with strong program-level planning and risk management
Independently apply clinical trials knowledge to problems that arise during the conduct of a study
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, multitask, prioritize tasks, anticipate challenges, and execute on goals as a member of an interdisciplinary team
Travel may be required (~25%)
Preferred
Decision-making skills
Has familiarity working with vendor systems/portals (e.g., eTMF, EDC, IRT, CTMS)
Oncology experience, early and/or late stage, strongly preferred
Company
Bayside Solutions
Bayside Solutions is a staffing and recruiting company offering IT, telecom, and scientific staffing services.
51-200 employees
Funding
Current Stage
Growth StageLeadership Team
B
Bob Klotz
Founder
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