In this unique hybrid role, the Sr. Manager/AD of Clinical Monitoring and Documentation is responsible for the management and oversight of Monitoring and Trial Master Files (TMFs) for Inozyme clinical trials. Through the collective oversight of these integral activities, the Sr. Manager/AD of Clinical Monitoring and Documentation will ensure the quality of data at study sites as well as study documentation in the Investigator Site Files (ISFs) and TMFs. In addition, the individual will ensure monitoring and TMF activities are conducted in accordance with applicable policies, procedures, and regulations, including but not limited to, Standard Operating Procedures (SOPs), Good Clinical Practice (GCPs) Guidelines, and International Conference on Harmonisation (ICH) guidelines.
This is a full-time position reporting to the VP, Clinical Trial Operations, and is located Boston, MA, or remotely.
- Ensure the standardization, consistency and quality of monitoring practices across clinical trials by ensuring compliance with policies, procedures and plans; ensuring qualifications and training of study monitors (CRAs), internally or at a CRO; trend analysis of key indicators of study site and monitoring performance; review and approval of trip reports; quality assessment visits to assess CRA performance, risk assessment and mitigation strategies, and continuous quality improvement
- For monitoring conducted by CRO, ensure the quality, performance and compliance of delegated responsibilities via robust monitoring oversight plans, key performance indicators and quality assessment visits
- Ensure studies are being conducted in accordance with the protocol, applicable regulatory requirements and study timelines,
- Ensure the quality and integrity of data; conduct site quality trend analysis and data review including queries and protocol deviations, trouble shoot and problem solve issues, escalate to the clinical project manager (CPM) and/or head of clinical operations, as needed
- In collaboration with clinical operations, ensure monitoring activities are consistent with study needs and modify monitoring plans as needed, identify sites requiring additional oversight and/or site visits, and prepare sites for regulatory agency inspections
- Conduct onsite visits to sites to identify areas of risk and implement mitigation strategies
- Lead and assist with study-related training of CRO personnel, and investigator site staff
- Attend and present at investigator and study coordinator meetings, as needed
- Actively participate in study team meetings
Clinical Documentation Responsibilities
- Responsible for the setup, oversight, and management of TMF vendors and/or systems
- Ensure the standardization, consistency, quality of TMF practices across clinical trials via TMF plans, policies and procedures
- Work in collaboration with study teams to establish study specific TMF specifications, structure and plans
- Ensure compliance with TMF policies, procedures and plans; promote importance of a high quality TMF and best documentation practice, provide guidance on document standards to support inspection readiness and adherence to Good Documentation Practices
- Implement TMF oversight plans inclusive of quality checks, risk assessment and mitigation analysis; triage and communicate quality issues and gaps, escalate as needed to study team and head of Clinical Operations
- In collaboration with clinical operations, drive TMF inspection readiness activities
- Work with key stakeholders on the continued development of TMF and Record Management practices and expectations
- Ensure study documentation is consistent with TMF specifications, submission/inspection readiness criteria
- Bachelor's Degree in life sciences, nursing, or biomedical field preferred
- 7 years of relevant monitoring and/or monitoring oversight experience with 3 years of direct monitoring experience, including lead CRA experience at a CRO or pharmaceutical /biotechnology company
- Experience managing people preferred
- Experience with eTMF systems, set up and implementation, including specifications, policies, procedures and plans
- Thorough knowledge of Trial Master File process/activities, regulatory requirements and Good Clinical Practice
- Advanced knowledge of clinical documentation and reporting
- Knowledge/understanding of DIA TMF Reference Model
- Experience in effectively communicating (written, verbal, presenting) with site staff, clinical investigators, Key Opinion Leaders, management.
- Experience and clear understanding of the mechanisms of all study phases of a clinical trial
- Comprehensive and current regulatory knowledge, including GCPs
- Ability to partner collaboratively with cross-functional team members and CRO staff
- Proven track record with innovative approaches to solve problems impacting clinical site delivery and quality.
- Good organizational skills and ability to deal with competing priorities
- Knowledge of applicable research and regulatory environments, i.e. International Conference on Harmonization (ICH), Good Clinical Practice (GCP)
Working Conditions and Physical Requirements
- May require occasional evening and weekend work.
- Ability to travel ~25%
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