Manager, Clinical Monitoring at Veristat in Remote

The Manager, CM will participate in the development and implementation of operational strategies, policies and procedures for the Clinical Monitoring Department, and ensure project deliverables meet client expectations. S/he oversees project activities related to CM, thereby ensuring that each clinical trial is progressing according to quality standards, and that trials are being conducted in accordance with timeline and budget, and in compliance with applicable regulations including but not limited to Standard Operating Procedures (SOPs), Good Clinical Practice (GCPs) Guidelines, and International Conference on Harmonisation (ICH) guidelines.

The Manager, CM may also be accountable for multiple projects/clients and is expected to manage client relationships and expectations, and deliver results, successfully. S/he maintains a proactive, positive, results oriented work environment.

As a Manager, Clinical Monitoring You Will...

• Be responsible for the direct management of all CM staff, including performance management, career development, growth, training, and employee relations
• Be responsible for resourcing and project staffing; therein, assists with assessing hiring needs, interviews, and hires to align with the needs of the department
• Work with the CM project teams to routinely monitor project activities against scopes of work to ensure operations are consistent with scope and assists with identifying changes in project scope or efficiencies to maintain timelines and budget
• Work with CM project teams to evaluate and monitor project team resources and collaborate with corresponding departmental management in resource allocation planning
• Assist with business development activities, including participating in bid defenses, client/governance meetings, and the development of business proposals as it pertains to CM
• Participate in development and maintenance of CM SOPs, tools, and document templates and/or development of clinical trial related documents
• As necessary, may serve as and perform the duties of Lead CRA on assigned studies
• Design, communicate, and implement study tracking and timeline management tools
• Review study protocols and recommend monitoring approach, including monitoring visit frequency, acceptable level of source document verification, and key risk indicators
• Perform or oversee co-monitoring visits to ensure CRA performance is in alignment with expectations of the study specific monitoring plan
• Support and/or interface with external functions/groups, including service vendors and clinical site personnel
• Participate in and present at various meetings (investigator meetings, client meetings, corporate)
• Lead and/or participate in corporate compliance activities as it relates to CM, including: development and review of department policies, SOPs, and other controlled documents, as well as participation in client audits
• Mentor and train junior level staff, especially in the areas of effective time management, communication, utilization of study management processes, and tools
• Provide leadership and motivation to departmental personnel, develops training process and plans for the Clinical Monitoring team for therapeutic areas and/or any study related processes
• Participate in corporate initiatives, department and cross-functional process improvement initiatives and actions that ensure the continued success of the company
• Contribute to the continuous process improvement within the department; brings efficiencies and best practices to the organization through the design and implementation of new or updated procedures or workflows
• Lead by example and models core values in all actions; ensures a positive, respectful team environment, fostering collaboration and development

Experience + Requirements

• Bachelor’s degree in a related field required, preferably in a health, science or CRO/pharmaceutical industry-related discipline
• 8 years of relevant Clinical Monitoring experience in a CRO or similar organization, with at least 3 years of supervisory experience or 5 years of project lead experience required
• Prior experience with Risk Based Monitoring experience preferred
• In-depth understanding of the drug development process as well as the operational and regulatory aspects of clinical development, including thorough knowledge of ICH/GCP and regulatory environment; International experience a plus
• Thorough knowledge of Clinical Operations and Clinical Development processes, Veristat Processes and procedures, SOPs and standard tools
• Strong presentation skills required; must be able to present in front of clients, internal staff and executive management as needed
• Ability to solve problems effectively and efficiently, and has practical experience building trust and relationships, consistently demonstrating integrity and credibility
• Experience in using CTMS, eTMF, IVRS, and e-CRF systems required
• Excellent clinical trial management skills, written and oral communication, organizational, time management, and interpersonal skills are required for both internal and external interactions
• Experience managing multi-center and international studies required
• Action-oriented and resilient in a fast-paced environment and will have the ability to build effective project teams, motivate others, delegate, and make and implement decisions
• The ability to build and maintain trust and confidence and communicate effectively with client, external vendors, and internal team members
• Sufficient knowledge of study specific therapeutic areas to enable appropriate input to study documents (e.g., protocols, CRFs, EDC development)
• Proficient in Microsoft Office tools
• Highly self-motivated and proactive, ability to be a team player and work independently
• Demonstrated ability to analyze risk and take advanced steps to mitigate future issues, all while delivering work in a high-pressure environment
• Flexible, adaptable, and confident when approaching new tasks and work environments
• Attention to detail, a passion for efficiency, and the desire to complete projects on time.