Director, Cross TA Clinical Risk Mgmt

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We are searching for the best talent for Director Cross TA Clinical Risk Management to join our Quality Assurance and Compliance organization located in Allschwil Switzerland; Beerse Belgium; High Wycombe UK.

Please note that this role is available across multiple countries and may be posted under different requisition numbers to comply with local requirements. While you are welcome to apply to any or all of the postings we recommend focusing on the specific country(s) that align with your preferred location(s):

Raritan NJ; Titusville NJ; Horsham PA; Spring House PA; or Miami FL - Requisition Number: R-060754

Remember whether you apply to one or all of these requisition numbers your applications will be considered as a single submission.

The Director Cross TA Clinical Risk Management reports to the Head of Clinical Risk Management and is primarily responsible to oversee the overall risk management of the Cross TA Delivery Unit for Neuroscience Cardiopulmonary and Communicable Disease late development trials. They work with the CRM Representatives to ensure the coordination of the identification assessment and mitigation of quality risks that could have an impact on trial data integrity patient rights safety or wellbeing.

Key responsibilities:

• Oversee the execution of data-driven risk-based trial and program oversight activities that deliver quality in the execution of clinical trial programs compliance with regulatory requirements and internal procedures and that there is a continued state of inspection readiness;
• Manage a team of CRM representatives that will provide consistent quality oversight to clinical trials in the Cross TA portfolio;
• Provide and lead strategic guidance to CRM representatives on quality risk assessments risk entries and mitigation strategies. Approve CQP (Clinical Quality Plans) risk monitoring information in the quality risk repository to facilitate regular progress reviews;
• Independently drive quality risk monitoring reviews and coach others on risk monitoring and mitigation reviews;
• Ensure a strategic communication framework with business partners and quality management governance to keep them informed on key quality risks and mitigations;
• Communicate and facilitate risk updates to R&D Business Partners as part of the regular review cycle through Quality Working Groups and Governance Fora as applicable (trial and/or compound as assigned);
• Develop and ensure a consistent interpretation of issues that require quality investigations;
• Provide guidance for significant quality issues (SQI) per corporate standards and escalates SQI to senior R&D management;
• In collaboration with partners in RDQ provide advice on the development and implementation of Corrective and Preventative Action (CAPA) Plans and Effectiveness Checks (Self - Identified Inspection Audit);
• Independently lead key inspection processes and inspection tools to maintain an ongoing inspection readiness with trial teams to develop inspection narratives identify and prepare sites of interest for inspection (including pre-inspection visit support) ensure availability of key documents/records and coordinates mock inspection in collaboration with Regulatory Compliance teams;
• Provide remote support for investigational site inspections including post inspection support;
• Provide independent advice on questions related to research quality and compliance from Business Partners in collaboration with other Quality Professionals and Subject Matter Experts to ensure consistent interpretation of international regulations and policy;
• Participate in CRM cross-RDQ JJIM cross-functional or cross-sector working groups to develop or refine processes tools and systems that deliver innovative quality solutions (as a team member or workstream/project lead);
• Work with limited supervision independently making quality decisions for compounds and studies;
  

The Director Cross TA Clinical Risk Management is highly visible to the RDQ Leadership team and ensures robust quality trial oversight of the Cross TA portfolio through quality risk management and execution of quality support services.

Qualifications:

• A minimum of a Bachelors degree (scientific medical or related discipline) is required.
• Advanced degree in an applicable field of study or certification is preferred.
• A minimum of 10 years working in the healthcare industry (pharmaceutical industry contract research organization and/or healthcare/hospital system) is required.
• Demonstrates experience or recognizes potential for people leadership in formal or informal setting as needed is required.
• Proven strong GCP Quality and/or clinical trials experience is required.
• Excellent interpersonal oral and written communication skills to effectively collaborate in a cross-functional team environment is required.
• Flexibility to respond to changing business needs is required.
• Demonstrated ability to operate in an environment of culturally diverse styles and business approaches by understanding regional and global business structures is required.
• Proficiency in Microsoft Office Applications is required.
• Experience with fundamentals of clinical trial risk management is preferred.
• Experience working to ICH guidelines is preferred.
• Knowledge of Good Manufacturing Practice (GMP) Good Laboratory Practice (GLP) and/or Good Pharmacovigilance Practice (GPvP) is preferred.
• Health Authority Inspection experience (FDA EMA and other inspectorates) is preferred.
• Immunology Drug Development experience is preferred.
• Strong Project Planning/Management skills is preferred.
• Experience in managing escalations and CAPA support/advisement is preferred.
• Experience and/or proficiency with data analytics and/or data visualization tools (i.e. Tableau Spotfire or related) to analyze/interpret collective data and provide insights to drive decision-making is preferred.
• Experience with Data Science and Digital Health (including Real World Evidence/Real World Disease) is preferred.
• Requires proficiency in speaking and writing English.
• Requires up to 10% travel primarily domestic with some international travel.

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