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Manager, Clinical Quality Assessment Auditor

Expired Job

Sanofi Bridgewater , NJ 08807

Posted 2 months ago

The Manager, Clinical Quality Assessment (CQA) Auditor is responsible for the initiation, conduct, and follow-up of audits as assigned by CQA Management. Within the frame of the Manager, CQA Auditor's mission and responsibilities, the audits and activities require proven ability to independently interact with all internal (e.g. Projects Teams, Trial Operations) and external (e.g. Vendors / CRO) operational staff involved in the audited clinical research activities. The Manager CQA Auditor's responsibilities also include the mission of GCP Project Representative for the projects assigned by CQA Management. Further responsibilities include coordination and management of inspection support, conduct of investigations of Scientific Misconduct and Serious GCP Non-Compliance and the handling of outsourced activities performed by external consultants on behalf of CQA, as required and assigned by CQA Management.

Responsibilities:

  • Independently manages and performs compliance audits of Contract Research Organizations (CRO), Systems and Clinical Investigator sites for Phase I to IV clinical trials performed by the CSO Platform. CRO / System audits include external and/or internal processes such as IVRS, central labs, monitoring, data management, filing/archiving, medical writing, GCTM, study start up, DRS etc. Lead both routine and complex directed audits. During Investigator site audits, the Manager, CQA Auditor has direct access to subject individual data for records review. The Manager, CQA Auditor is bound by professional secrecy and as such will not disclose any individual identity and/or individual medical information.

  • Represents CQA on various project/study team meetings. Acts as GCP Project Representative to provide quality and continuous improvement support at the study/project level. This includes responsibilities such as: (a) Follow-up on progress status of assigned project(s), (b) Establishment of regular contacts with operational teams, (c) Advice and consultation on GCP and Quality issues, (d) Identifying and analyzing potential issues with impact on quality, (d) Contribution to audit planning / programs and assistance in the monitoring of the implementation of those programs, (e) Participation in the analysis of results of audits for the assigned projects and (f) Proposing improvements and/or process changes

  • As requested by CQA Management may represent the sponsor during Regulatory Inspections. This will include preparation, coordination and communication to management

  • In liaison with management, manages cases of Scientific Misconduct and Serious GCP Non-Compliance.

  • When required, manages clinical auditing activities performed by external GCP QA auditors and assures CQA Management those activities are performed in a timely manner.

  • Assists in the design and participate in training on CQA activities and other topics related to GCP, regulations, and guidelines, etc.

  • Participates in the development, revision, and implementation of CQA Quality Documents, working methodologies, tools and systems.

  • Provides knowledge updates in areas pertaining to GCP Regulations / Guidelines / Good Practices through review of literature and participation in relevant internal and external meetings/workshops/symposia.

  • Supports the coaching of less experienced and / or newly hired GCP Quality Assurance Specialist(s).

Required Education/Experience

  • Bachelor degree in a life / medical / natural sciences or scientific discipline or related area

  • Minimum 3 years audit and GCP experience

  • Ability to travel (25%+)

  • GCP experience required

  • Experience in Clinical Quality Assurance and/or in Clinical Trials such as Monitoring or Clinical Trial Management with good performance

  • Extensive working knowledge of international regulations/Guidelines/Good Practices pertaining to the clinical domain

  • Good working knowledge of standard computer office software such as Word, Email system (Outlook), PowerPoint and Excel

  • Good business communication skills in English (orally / in writing)

  • Good analytical abilities and attention to detail

  • Ability to communicate clearly and effectively and to foster productive dialog on topics of advance complexity

  • Ability to deal with multi-cultural environments

  • Capacity to work in team oriented environment

  • Current regulatory knowledge

Sanofi US Services, Inc. and its U.S. affiliates are Equal Opportunity and Affirmative Action employers committed to a culturally diverse workforce. All qualified applicants will receive consideration for employment without regard to race; color; creed; religion; national origin; age; ancestry; nationality; marital, domestic partnership or civil union status; sex, gender, gender identity or expression; affectional or sexual orientation; disability; veteran or military status or liability for military status; domestic violence victim status; atypical cellular or blood trait; genetic information (including the refusal to submit to genetic testing) or any other characteristic protected by law.

#LI-SA

#GD-SA

Sanofi US Services, Inc. and its U.S. affiliates are Equal Opportunity and Affirmative Action employers committed to a culturally diverse workforce. All qualified applicants will receive consideration for employment without regard to race; color; creed; religion; national origin; age; ancestry; nationality; marital, domestic partnership or civil union status; sex, gender, gender identity or expression; affectional or sexual orientation; disability; veteran or military status or liability for military status; domestic violence victim status; atypical cellular or blood trait; genetic information (including the refusal to submit to genetic testing) or any other characteristic protected by law

The Manager, Clinical Quality Assessment (CQA) Auditor is responsible for the initiation, conduct, and follow-up of audits as assigned by CQA Management. Within the frame of the Manager, CQA Auditor's mission and responsibilities, the audits and activities require proven ability to independently interact with all internal (e.g. Projects Teams, Trial Operations) and external (e.g. Vendors / CRO) operational staff involved in the audited clinical research activities. The Manager CQA Auditor's responsibilities also include the mission of GCP Project Representative for the projects assigned by CQA Management. Further responsibilities include coordination and management of inspection support, conduct of investigations of Scientific Misconduct and Serious GCP Non-Compliance and the handling of outsourced activities performed by external consultants on behalf of CQA, as required and assigned by CQA Management.

Responsibilities:

  • Independently manages and performs compliance audits of Contract Research Organizations (CRO), Systems and Clinical Investigator sites for Phase I to IV clinical trials performed by the CSO Platform. CRO / System audits include external and/or internal processes such as IVRS, central labs, monitoring, data management, filing/archiving, medical writing, GCTM, study start up, DRS etc. Lead both routine and complex directed audits. During Investigator site audits, the Manager, CQA Auditor has direct access to subject individual data for records review. The Manager, CQA Auditor is bound by professional secrecy and as such will not disclose any individual identity and/or individual medical information.

  • Represents CQA on various project/study team meetings. Acts as GCP Project Representative to provide quality and continuous improvement support at the study/project level. This includes responsibilities such as: (a) Follow-up on progress status of assigned project(s), (b) Establishment of regular contacts with operational teams, (c) Advice and consultation on GCP and Quality issues, (d) Identifying and analyzing potential issues with impact on quality, (d) Contribution to audit planning / programs and assistance in the monitoring of the implementation of those programs, (e) Participation in the analysis of results of audits for the assigned projects and (f) Proposing improvements and/or process changes

  • As requested by CQA Management may represent the sponsor during Regulatory Inspections. This will include preparation, coordination and communication to management

  • In liaison with management, manages cases of Scientific Misconduct and Serious GCP Non-Compliance.

  • When required, manages clinical auditing activities performed by external GCP QA auditors and assures CQA Management those activities are performed in a timely manner.

  • Assists in the design and participate in training on CQA activities and other topics related to GCP, regulations, and guidelines, etc.

  • Participates in the development, revision, and implementation of CQA Quality Documents, working methodologies, tools and systems.

  • Provides knowledge updates in areas pertaining to GCP Regulations / Guidelines / Good Practices through review of literature and participation in relevant internal and external meetings/workshops/symposia.

  • Supports the coaching of less experienced and / or newly hired GCP Quality Assurance Specialist(s).

Education/Experience

  • Bachelor degree in a life / medical / natural sciences or scientific discipline or related area

  • Minimum 3 years audit and/or GCP experience

  • Ability to travel (25%+)

  • GCP experience required

  • Experience in Clinical Quality Assurance and/or in Clinical Trials such as Monitoring or Clinical Trial Management with good performance

  • Extensive working knowledge of international regulations/Guidelines/Good Practices pertaining to the clinical domain

  • Good working knowledge of standard computer office software such as Word, Email system (Outlook), PowerPoint and Excel

  • Good business communication skills in English (orally / in writing)

  • Good analytical abilities and attention to detail

  • Ability to communicate clearly and effectively and to foster productive dialog on topics of advance complexity

  • Ability to deal with multi-cultural environments

  • Capacity to work in team oriented environment

  • Current regulatory knowledge

Sanofi is dedicated to supporting people through their health challenges. We are a global biopharmaceutical company focused on human health. We prevent illness with vaccines, provide innovative treatments to fight pain and ease suffering. We stand by the few who suffer from rare diseases and the millions with long-term chronic conditions.

With more than 100,000 people in 100 countries, Sanofi is transforming scientific innovation into healthcare solutions around the globe.

Sanofi, Empowering Life

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Manager, Clinical Quality Assessment Auditor

Expired Job

Sanofi