Risk Manager - RBQM at Actalent — NeverHard

Job DescriptionJob Description Job Title: Risk Manager Job Description The Manager, Risk-Based Quality Management (RBQM) plays a critical role in ensuring the quality and compliance of clinical trial execution. This position serves as a subject matter expert in Risk-Based Quality Management, performing responsibilities associated with both Clinical Risk Management Lead and Central Monitoring Lead functions. The role involves driving effective risk-based approaches to protect patient safety, ensure data integrity, and enhance operational efficiency by partnering closely with internal teams and Contract Research Organizations. Responsibilities Lead cross-functional trial-level risk assessments, identifying critical factors, data, processes, and risks in collaboration with various departments. Maintain trial-specific Risk Assessment and Categorization Tool documentation or oversee its development and revision. Facilitate periodic risk reviews throughout study conduct to assess new or changed risks. Review Quality Tolerance Limit findings and deviations, supporting root cause assessment and mitigation planning. Serve as the Central Monitoring subject matter expert, confirming and overseeing trial-specific strategies. Provide input into trial-specific monitoring strategies, including risk-based monitoring components. Partner with various teams to assess whether emerging risks require updates to monitoring strategies. Translate risk controls and monitoring components into technology requirements. Conduct Central Monitoring reviews, analyzing data outputs, trends, and anomalies. Facilitate internal Central Monitoring review meetings and track findings and actions through resolution. Promote a proactive quality culture by encouraging consistent application of RBQM principles. Identify lessons learned, process inefficiencies, and opportunities for improvement. Essential Skills Minimum of 6 years of experience in clinical research, clinical operations, clinical quality, data management, or monitoring. At least 2 years of experience with Risk-Based Quality Management, clinical risk management, central monitoring, or related quality oversight activities. Bachelor’s degree or equivalent work experience, preferably in life sciences, healthcare, or a related field. Working knowledge of Good Clinical Practice, International Council for Harmonisation guidelines, and clinical trial conduct. Experience with clinical systems and data outputs, such as Clinical Trial Management Systems and Electronic Data Capture. Strong organizational, analytical, communication, stakeholder management, and problem-solving skills. Proficiency in Microsoft Office, including Excel. Additional Skills & Qualifications Experience with Elluminate or CluePoints is a plus. Demonstrated ability to facilitate cross-functional discussions and partner with CROs/service providers. Work Environment This role is remote in Canada, operating on East Coast hours, and requires 40 hours per week. Job Type & Location This is a Contract position based out of Mississauga, ON. Pay and Benefits The pay range for this position is $85.00 - $95.00/hr. Workplace Type This is a fully remote position. À propos d'Actalent Actalent est un leader mondial dans les services d’ingénierie et de sciences ainsi que dans les solutions de talents. Nous aidons des entreprises visionnaires à faire progresser leurs initiatives d’ingénierie et de science grâce à l’accès à des experts spécialisés qui favorisent l’échelle, l’innovation et la rapidité de mise sur le marché. Avec un réseau de près de 20 000 consultants et 5 000 clients à travers les États-Unis, le Canada, l’Asie et l’Europe, Actalent dessert de nombreuses entreprises du Fortune 500. Nous sommes fiers d’être l’une des 500 meilleures firmes de conception de l’Engineering News-Record (ENR) pour nos services de conception en ingénierie et un lauréat du prix ClearlyRated Best of Staffing® tant pour le service client que pour les talents. Actalent est un employeur souscrivant au principe de l’égalité des chances et accepte toutes les candidatures sans tenir compte de la race, du sexe, de l’âge, de la couleur, de la religion, des origines nationales, du statut d’ancien combattant, d’un handicap, de l’orientation sexuelle, de l’identité sexuelle, des renseignements génétiques ou de toute autre caractéristique protégée par la loi. Si vous souhaitez faire une demande d’accommodement raisonnable, tel que la modification ou l’ajustement du processus de demande d’emploi ou d’entrevue à cause d’un handicap, veuillez envoyer un courriel à actalentaccommodation@actalentservices.com pour connaître d’autres options d’accommodement. Ordonnance sur l’égalité des chances de San Francisco: Conformément à l’Ordonnance sur l’égalité des chances de San Francisco, pour tous les postes situés dans la ville et le comté de San Francisco, nous examinerons les candidatures des personnes qualifiées ayant un casier judiciaire ou des antécédents criminels. Utilisation de l’intelligence artificielle (IA): Nous pouvons utiliser l’intelligence artificielle (IA) pour soutenir certaines étapes de notre processus d’embauche, notamment la recherche, la présélection et l’évaluation des candidatures. L’IA aide à analyser les candidatures et les qualifications, mais les décisions finales sont prises par notre équipe de recrutement. En soumettant votre candidature, vous reconnaissez et acceptez que celle-ci puisse être examinée à l’aide d’outils d’IA. About Actalent Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market. With a network of almost 20,000 consultants and 5,000 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500. We are proud to be an Engineering News-Record (ENR) Top 500 Design Firm for our engineering design services and a ClearlyRated Best of Staffing® winner for both client and talent service. The company is an equal opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law. If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing process due to a disability, please email actalentaccommodation@actalentservices.com for other accommodation options. San Francisco Fair Chance Ordinance: Pursuant to the San Francisco Fair Chance Ordinance, for all positions located in the city and county of San Francisco, we will consider for employment qualified applicants with arrest and conviction records. Use of Artificial Intelligence (AI): We may use Artificial Intelligence (AI) to support parts of our hiring process, including sourcing, screening, and evaluating candidates. AI helps assess applications and qualifications, but final decisions are made by our hiring team. By applying, you acknowledge and agree that your application may be reviewed using AI tools.