Responsible for managing assigned Research and Development (R&D) Quality Risk Management activities at client, including assessment and quality control of client’s clinical trials' execution in a Good Clinical Practices (GCP) regulated environment. Additional areas of support include Drug Safety and Pharmacovigilance, Computer System Validation and Good Laboratory Practices (GLP).
Candidate will be required to work closely with internal R&D teams and Contract Service Providers (CSPs) as clinical trials are designed and conducted.
Will be required to identify emerging issues and compliance risks, measure performance metrics, and suggest opportunities for improvement for clinical trial related processes and procedures and contribute to (or lead efforts to) their implementation.
Potential to coach and support junior associates in R&D Quality Risk Management (R&D QRM) department, where needed.
Primary Responsibilities:
Contribute to effective quality control and risk management of client R&D procedures and processes. Ensure the continuous improvement of clinical trial processes and associated SOPs within Clinical Operations, trial monitoring, Data Management and Pharmacovigilance (PV).
Create new appropriate process and/or compliance indicators (semi-automated metrics and manual spot-checks) in order to reinforce adherence to internal processes and procedures and to identify areas for improvement. Calculate, track and report such indicators on a continual basis.
Work in close collaboration with colleagues in R&D Quality Management, client operational units in Drug Development (Clinical Development, Clinical Operations, Data Management, Manufacturing, Medical Affairs, Laboratories, Pharmacovigilance, Regulatory Affairs, Translational Medicine, vendors (CSPs) and partners in GMP QA).
Provide input on quality and compliance concerns and lead implementation of trial risk management strategies in support of clinical development teams, CROs, contractors and consultants.
Maintain and where needed update aspects of the R&D QRM framework, e.g. internal procedures, processes training modules and tools. Lead the organization through QRM related changes, e.g. updates from ICH, regulatory guidances and business best practices.
Scope:
May provide guidance to subordinates and/or manage department section, to achieve goals in accordance with established policies and to meet schedules and/or resolve problems. Receives assignments in the form of objectives. Follows processes and operational policies in selecting methods and techniques for obtaining solutions; determines how to use resources to meet schedules and goals. Works on issues of diverse scope which require evaluation of a variety of factors ad an understanding of functional area objectives and trends.
Erroneous decisions or failure to achieve results may add to costs and impact the short-term goals of the organization.
Skills:
Experience: An equivalent combination of relevant education and applicable job experience may be considered.
Minimum of 6 years R&D focused pharmaceutical/Health Care experience in a GCP regulated environment including some experience in R&D Quality Risk Management or R&D Quality Assurance systems and Health Authority regulations.
Experience in a matrix team environment and involvement and contribution to continuous improvement projects.
Must possess:
Experience with drug development process, including affinity with clinical protocol development, global trial management, site management & monitoring, drug safety, biostatistics & programming and/or data management.
Strong knowledge of GCP, including affinity with quality management and performance metrics and experience with Root Cause Analysis and CAPA development.
Experience with multiple IT programs and systems, including but not limited to Clinical Trial Management systems, eTMF, eCRFs, Microsoft Office (including above average Excel skills), quality workflow systems.
Knowledge of Good Laboratory Practices, PV, FDA and/or EMA/MHRA regulations.
Excellent communication skills, both verbal and written. Able to work independently as well as in cross-functional teams.
Flexibility to switch between projects and assignments; ability to manage multiple projects, work streams and activities on a daily basis.
Ability to establish and maintain frequent internal and external relationships with Development, Regulatory Affairs, Pharmacovigilance & Legal departments, regulatory agencies, CROs, clinical investigators, etc. Ability to interpret and apply practical knowledge of regulations and guidelines for the immediate resolution of compliance issues and the pro-active management of GCP and PV quality risks – under supervision if needed.
Ability to assess regulatory/compliance risk, identify areas of improvement and propose practical solutions.
Skilled at working effectively with business partners and management and appropriately signal and escalate matters of significance to the organization.
Ability to travel up to 10% of the time.
Desired: Experience with organizational change management, especially as it relates to embracing and promoting a culture of quality. Experience with multi-sized organizations from start-up to large employers. Experience with QA audits and Health Authority Inspections by FDA, EMA, MHRA, and PMDA. Experience with Computer System Life Cycle management and principles. Familiarity with Central Nervous System (CNS) therapeutic area is a big plus.
Applicant Notices & Disclaimers
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At SPECTRAFORCE, we are committed to maintaining a workplace that ensures fair compensation and wage transparency in adherence with all applicable state and local laws.This position's pay range is $45.00/hr - $51.00/hr.
