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Senior Director, Clinical Compliance

Company: Green Key Resources
Location: Somerville
Posted on: January 20, 2023

Job Description:

Reporting to the VP, Head of Clinical Operations, the Director of Clinical Compliance oversees strategic and tactical operations focused on 1) GCP Compliance and 2) Clinical Supply / Unblinded Clinical Operations. -The Director of Clinical Compliance provides management oversight to direct reports and department-wide mentorship. - -Responsibilities:GCP COMPLIANCEPlan, optimize, implement, manage, and continuously-improve Standard Operating Procedures (SOPs), processes, communication, and infrastructure within Clinical OperationsWork with the Head of Clinical Operations to support timely and in-budget completion of department goals by ensuring compliance and continuity as follows: - - - - -*Lead departmental initiatives aimed at innovation, process improvement, and efficiency (e.g. eTMF implementation) - - - - -*Facilitate cross functional process improvement initiatives (e.g., liaising with IT to support IT systems and technology-related improvements - - - - - -*Establish key vendor oversight plans and processes (e.g., Clinical Study Oversight Plan, Co-monitoring, toolkit, etc.)- Collaborate with Clinical Operations Leads to establish performance and quality metrics for the study, and report metrics and that drive quality and efficiency- Ensure state of inspection readiness: - - - - - -*Oversee GCP Inspection Management activities ensuring appropriate training and tools are in place for the Clinical Operations organization. - - - - - -*Lead internal Sponsor inspection-readiness working groups for all programs, ensuring storyboards are created and risk areas are documented, mitigated, and escalated. This is a cross-functional activity, including representation from Clinical Operations, Clinical Development, Pharmacovigilance and other areas as indicated. - - - - - -*Contribute to GCP Inspection Readiness Steering Committee. - - - - - -*Develop strategy for inclusion of Vendors/CROs in Sponsor inspection-readiness. - - - - - -*Drive and organize Q&A sessions for the Clinical Operations organization. - - - - -*Support Investigator Sites in Inspection Preparation activities and/or actual Health Authority inspections in collaboration with Quality Assurance. May travel to investigative sites for this purpose. - - - - - -*Contribute to the review and follow-up of GCP inspection findings. -- Create an effective interface with Quality Assurance to ensure GCP compliance across the clinical operations organization, including: - - - - - -*Actively engage with QA to ensure vendors and clinical sites are audited regularly and develop strategic audits as they relate to clinical studies - - - - -*Contribute to audit strategy during vendor selection and use a risk-based approach to identify sites for audit - - - - -*Coordinate audit scope (pre-audit) and post-audit activities with relevant Clinical Study Team members and stakeholders - - - - -*Attend Audit Debriefs for Investigator Site Audits, GCP Vendor/CRO audits, and Clinical Operations internal audits. - - - - -*Review Audit Reports - - - - -*Support Clinical Operations in managing activities associated with Audits: As needed, assist the clinical trial teams in responding to audit findings, ensuring appropriate root cause is performed and CAPAs are created. Ensure all items are documented appropriately. - - - - - -*Escalate audit observations that are critical or of significant safety impact - - - - - - - -*Contribute to identification of relevant audit trends and implementing process changes to address any gaps - - - - - -*Review audit metrics prepared by Quality and work with Clinical Operations and Quality to identify additional training needs and/or Process Improvement activities. --Function as GCP Risk Facilitator, ensuring risks to clinical trial activities are documented, mitigated and escalated as appropriate.- Stay current with new and revised regulations and trends in industry standard and serve as a GCP subject matter expert and provide guidance to internal Clinical Operations organization. This may involve attending industry conferences.- Manage direct reports to support professional development and timely completion of goals- Ensure GCP compliance by providing guidance and support to Clinical Operations Leads and Clinical Study TeamsCLINICAL SUPPLY / UNBLINDED CLINICAL OPERATIONS- Serve as unblinded project lead on double-blinded clinical studies (including development and review of all plans as they relate to unblinded activities; set-up of IRT system; pharmacy manual development; contact with unblinded CRO and site personnel as required; review of unblinded documentation such as drug accountability logs; review of unblinded monitoring reports)Education and Experience:- Minimum of 8+ years industry experience in a Clinical Quality Assurance or Clinical Compliance role.- -Strong working knowledge of FDA, EU, and other global regulations and ICH GCP E6 (R2) and other guidance documents governing GCP.- Experience conducting GCP inspection readiness activities and/or hosting EMA and/or FDA inspections.- Ability to work effectively in a collaborative team environment where results are achieved through influence and the incorporation of multiple points of view.- Independently motivated, detail-oriented and strong problem-solving ability.- Excellent organizational skills, ability to multi-task in an extremely fast-paced environment with changing priorities.- Excellent verbal and written communication skills.- Experience in a start-up environment preferred.- Proven track record of effective leadership.- Must be pro-active team player, flexible, and open to change.- Experienced in multiple phases of research preferred.- Travel: national and international

Keywords: Green Key Resources, Somerville , Senior Director, Clinical Compliance, Executive , Somerville, Massachusetts

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