Senior Director, Clinical Compliance
Company: Green Key Resources
Location: Somerville
Posted on: January 20, 2023
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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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