Job Description
About the position
The
Senior Manager will be responsible for the overall oversight of clinical studies, ensuring the quality and integrity of risk-based monitoring deliverables. This involves developing comprehensive QCO Plans in collaboration with Clinical Trial Managers (CTMs) to detail strategies for maintaining high standards in monitoring activities. The role encompasses supporting study risk assessments and defining RBQM study needs and strategies, which include determining the frequency and requirements for onsite versus remote monitoring activities, targeted SDV and SDR, and fostering constructive collaboration with cross-functional teams such as biometrics/data management, eTMF, and medical/safety monitoring.
Additionally, the
Senior Manager will contribute to process excellence by maintaining and continually improving standard operating procedures related to clinical monitoring, Risk-Based Quality Management, and clinical trial oversight. This includes reviewing and collaborating on the development of study plans that define risk-based monitoring strategies and tasks necessary for overseeing critical study data and processes. The role requires presenting QCO roles and procedures to study teams and CROs, training CROs on QCO expectations, and overseeing and evaluating monitoring deliverables such as Monitor Visit Reports, CTMS data, essential documents, and critical system reports.
The
Senior Manager will actively participate in study team teleconferences with CRO/vendors, conduct site visits, present findings, serve as the point of contact for CROs regarding QCO activities, and provide guidance on issue resolution. Consultation with CTMs and CROs to create action plans based on QCO findings to improve monitoring quality is also a key responsibility. Furthermore, the role includes overseeing CRAs, monitoring activities, and performing management tasks such as MVR reviews, accompanied visits, and CRA teleconferences.
Close collaboration with cross-functional study team members and critical business partners is essential to implement day-to-day oversight activities while serving as a subject matter expert. The
Senior Manager will perform gap assessments for internal and external SOPs/processes, identify areas for process improvement in line with current guidance and global regulations, leverage lessons learned to enhance procedures, and develop related tools, templates, and training materials. Leading training activities for QCO representatives, CRAs, and cross-functional study team members is also part of the job scope.
Responsibilities • Review and collaborate to develop fit-for-purpose study plans that define risk-based monitoring strategies and the related tasks necessary to oversee critical study data and process. • Present QCO role and procedures to study team and CRO and train the CRO on the expectations for QCO activities. • Oversee and evaluate monitoring deliverables/outputs including review of Monitor Visit Reports and related CTMS data, eTMF/ISF essential documents, data capture and related queries, critical system reports or analytics.
• Participate in study team teleconferences with CRO/vendors as necessary, conduct site visits, present findings from QCO visits and monitoring report reviews. • Serve as the point of contact for CRO for QCO activities and provide guidance on issue resolution. • Consult with CTM and CRO to create action plans based on QCO findings to improve monitoring quality. • May perform management of CRAs and oversee monitoring activities including MVR review, accompanied visits and CRA teleconferences. • Close collaboration with cross functional study team members and critical business partners to implement day-to-day oversight activities and serve as a subject matter expert.
• Perform gap assessments for internal and external SOP/processes. • Identify areas for process improvement in consideration of current guidance's and global regulations. • Effectively leverage lessons learned to elucidate areas for process improvement. • Develop related tools, templates, and training materials/work aids. • Lead training activities for QCO representatives, CRAs, and/or members of cross functional study team. • Support process improvement initiatives related to risk based and quantitative methods of sponsor trial oversight.
• Collaborate with study teams to define meaningful metrics with thresholds/limits. • Support study teams to develop and build data visualization tools. Requirements • Bachelor's degree in a relevant field. • At least 8 years minimum experience in clinical research monitoring, preferably including knowledge of infectious disease and other therapeutic areas of relevance to assigned projects. • A minimum of 5 years clinical trial experience within a pharmaceutical, biotechnology, or CRO required in a role leading others.
• Strong knowledge of GCP regulations and pertinent U.S. FDA Code of Federal Regulations. • Familiarity with risk-based monitoring strategies and tools. • Strong working knowledge of clinical systems: CTMS, EDC, eTMF, eCOA, and data visualization dashboards. • Proficient at reviewing and interpreting clinical monitoring reports, study data, and trends for quality oversight. • Demonstrated analytical thinking, attention to detail, and ability to manage multiple priorities. • Strong written and verbal communication skills, with the ability to present to internal teams, CROs, and external stakeholders.
Nice-to-haves • Broader GXP knowledge is a plus. • Experience with specific industry technology and systems such as Veeva Vault suite, Medidata RAVE, SharePoint, data visualization tools such as Spotfire, Tableau or other custom solutions. Apply tot his job