Sr. Manager ClinOps GCP Training

Foster City, CA


Contract Duration: 5-18 months


Rate: Negotiable


Salary: NA $1.00


Responsibilities:

• Excellent employment opportunity for a Sr. Manager ClinOps GCP Training in the Foster City, CA area.
• Candidates MUST be US Based/ the position can be remote however, there will be travel Required - 30%.
• Responsible for providing Subject Matter Expertise (SME) in support of the Clinical Operations Organization and associated Learning, Communications and Process teams.
• Will be a knowledge resource in all aspects of Clinical Trial Management including Study & Site Management, Vendor Oversight, Regulatory Compliance and Inspection Readiness.
• Serve as a key contributor to the development and maintenance of various ClinOps training curriculum, including Onboarding, Role-specific Process Training and Professional Development Programs ensuring all training reflects current industry best practices and regulatory standards in line with associated internal processes and systems.
• Serve as the "Go To" person within the organization for guidance and insight into Clinical Trial Management process and training questions.
• Also, independently, or with the support of the learning organization, facilitate in person or virtual training workshops, presentations or programs to positively influence inspection readiness.
• Ensuring a focus on quality within the ClinOps organization and may support management in the development, monitoring and delivery of related key performance metrics.
• May also act as business owner for assigned ClinOps Training processes and serve as the ClinOps (SME) in cross functional working groups; and may also contribute to the execution of CAPAs as it pertains to training directives.
• Will also be expected to proactively identify knowledge gaps and areas in need of additional or future training/communications support.
• Drive continuous process improvements and contribute to the development of on-going training/tools for new /existing staff.
• Influence departmental decisions, as appropriate, and understands/aligns priorities and deliverables with long-term business needs.
• Provide mentorship, task oversight and/or line management of junior training staff on applicable programs, processes and systems as needed.
• Interacts regularly with ClinOps LKM, Training & Communications, CONNECT and TALT/ELT to provide SME content development, review and delivery; and to determine needs for additional organizational resources or support.
• Supports training development and delivery for new hires and existing staff, including internal best practices, industry regulations, processes or systems as appropriate.
• Monitors external environment, regulatory/process, ICH/GCP changes impacting ClinOps Practices and ensures required changes are implemented.
• Provides clarification on processes or alternatively seeks advice from appropriate process owners or SMEs as needed.
• Acts as a business owner for assigned training processes, initiates/leads/supports process improvement initiatives and develops, reviews and delivers associated trainings, or communications as applicable.
• Facilitates ongoing quality improvement through communication of audit/inspection results and CAPAs via Lessons Learned.
• Provide GCP guidance and consultation to clinical teams.

• A minimum of 10 years of progressive experience within Clinical Operations, Clinical Trial Management, Clinical Trial Monitoring or related function within Pharmaceutical/ Biotech/ CRO or related field is required. (i.e., CRA, Quality, Audit, Regulatory Compliance or similar)
• Broad experience in the Pharmaceutical industry with a strong clinical development understanding.
• Expert knowledge of ICH Guidelines, FDA/ MHRA/EMA regulations, EU Clinical Trial
• Directive and other applicable industry regulations, processes and practices is required.
• Ability and experience in training development and delivery on critical aspects of Clinical Trial Management such as ICH/GCP Guidelines, Monitoring Oversight, Site Interactions, non-compliance, Risk management, Inspection readiness etc. is required.
• Recognized presentation/ facilitation experience within Industry organizations such as ACRP/SOCRA/DIA may be considered in lieu of formal/dedicated training role experience.
• Experience with Instructional/Learning design principles and application in a technical business environment is desired.
• Proven ability to transfer knowledge to others and deliver training sessions that ensure maximum impact and retention.
• Prior direct experience in Clinical Trial Monitoring and Site/PI Interaction across TAs strongly preferred.
• Prior people/team and project management experience.
• Excellent communication, presentation and facilitation skills; ability to write clearly and summarize information effectively as well as present complex information to diverse audiences.
• Ability to plan, organize, coordinate, manage and execute with minimal guidance and effectively navigate ambiguity.
• (Future state) Ability to travel as needed (up to 20%)
• Proficiency in English language (both oral and written)