Senior Manager, Monitoring Oversight

GENERAL SUMMARY:  

The Sr Manager Clinical Oversight Monitoring (COM Sr Mgr.) will be responsible for overseeing clinical monitoring activities performed by CRO and contract monitors, ensuring compliance with clinical monitoring plans, protocols, ICH/GCP guidelines, and related documents. They will work cross-functionally with stakeholders to maintain inspection readiness and monitoring quality, develop oversight processes, and SOPs. The role involves progressing the 4DMT monitoring oversight program, scaling operations across global programs, and managing organizational structure to meet regulatory and 4DMT requirements.  

RESPONSIBILITIES:   

• Manage the 4DMT COM function globally as required 

• Collaborate with management to develop a monitoring oversight function 

• Further develop, execute, and manage the Clinical Oversight Monitoring Plan and ensure compliance with industry standards 

• Develop, utilize, and oversee metrics tools to assure the oversight activities are conducted in accordance with applicable regulations, SOPs and trial and Travere objectives 

• Interacts closely with study team throughout the lifecycle of the study. 

• Conduct QC review of monitoring visit reports, monitor visit scheduling, report completion metrics, protocol deviations, issues, and action items to identify COM, monitor, site, and study-level issues. 

• Oversee the internal process of monitoring visit report reviews by COM team and finalization metrics to assure compliance with internal and trial-specific plans 

• Proactively identify trends, issues, and risks related to monitoring and monitoring processes/plans 

• Work cross-functionally to create shared solutions 

• Ensure cross-functional understanding of applicable regulations and requirements  

• Develop metrics as required 

• Other duties as assigned, nothing in this job description restricts management’s right to assign or reassign duties and responsibilities to this job at any time  

QUALIFICATIONS:  

Education:  

• Bachelor’s degree or master’s degree in related Life Sciences discipline.  Equivalent combination of education and applicable job experience may be considered.  

Experience:  

• It is preferred that the candidate have 8+ years of experience in a similar role. 

• Clinical Monitoring experience required, with a preference for Ophthalmology monitoring experience (retina experience is a definite plus) 

• Understanding of clinical trials and advanced knowledge of ICH-GCP, Clinical trials regulations, and applicable global and regional/country requirements. 

• Mastery of global regulatory requirements and guidelines  

• Inspection experience (MHRA/EMA experience a plus) 

• Previous management experience of direct reports 

• Excellent stakeholder management skills coupled with influencing and negotiation skills 

• Understanding of resource management and organizational capacity 

• Demonstrated ability to think strategically across the organization. 

Skills:  

• The ideal candidate will embody 4DMTs core values: Dare to Cure - Break Boundaries - Beyond Yourself - Prepare & Executive Relentlessly 

• Strong interpersonal communication (written and verbal), and organizational skills 

• Able to motivate a team to work effectively under a fast-paced and changing environment 

• Strong work ethic and demonstrated ability to deliver assignments on time 

• Proficient with office automation tools, such as Microsoft Office toolkit. 

• Strong professional experience in a similar role within the pharmaceutical industry. 

• Well organized with the ability to multitask, prioritize, and manage shifting responsibilities in a dynamic, cross-functional teamwork environment. 

• Excellent collaboration skills with strong attention to detail and the ability to multi-task and manage complexity. 

• Ability to adapt to modification and changes to project plans, demonstrating flexibility to implement new strategies and tactics to accommodate these changes. 

• Ability to travel as required.   

 Base salary compensation range: $114K - $181K 

 Please note, the base salary compensation range and actual salary offered to the final candidate depends on various factors: candidate’s geographical location, relevant work experience, skills, and years of experience. 

Last updated on Aug 21, 2024