Associate Director of Clinical Monitoring and Documentation
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Position Summary: Associate Director of Clinical Monitoring and Documentation
The Senior Manager/AD of Clinical Monitoring and Documentation is responsible for the management and oversight of Monitoring and Trial Master Files (TMFs) for clinical trials.
Responsibilities
Ensure the standardization, consistency and quality of monitoring practices across clinical trials by ensuring compliance with policies, procedures and plans;
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
Responsible for the setup, oversight, and management of TMF vendors and/or systems
Work in collaboration with study teams to establish study specific TMF specifications, structure and plans
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
Qualifications
Bachelor's Degree
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 with eTMF systems, set up and implementation, including specifications, policies, procedures and plans
Advanced knowledge of clinical documentation and reporting
Knowledge/understanding of DIA TMF Reference Model
Ability to partner collaboratively with cross-functional team members and CRO staff
If you or a Clinical Trial Associate you know think this could be an opportunity you would like to explore please send your most up to date resume to myself at to discuss this role. All referrals welcome!
Thank you!
EOE Statement: Specialist Staffing Group is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or veteran status.
