Clinical Trial Management II
121 Seaport Boulevard Boston, MA 02210 US
Duties: Assist the CPLs for the planning, implementation, execution and compliance of operational plans for clinical study/program with multiple clinical vendors in order to maintain inspection readiness. This is a tactical position and involves protocol execution at the site level via established vendor oversight and escalation pathways. Serve as a peer mentor for staff, as needed. Ensure quality of the trial master file through content (QC) review of document packages submitted for entry into the TMF and liaise with project teams to resolve any issues identified with the documents submitted. Depending on the program scope, the CTM II may have study level responsibilities similar to any other CTM.
• Customize/update any study-specific plans and process flows for multiple clinical vendors, as appropriate e.g., TMF Plan, site training plan, site monitoring plan, cross functional data review plan, IP release plan etc.
• Ensure quality of the trial master file through content (QC) review of document packages submitted for entry into the TMF and liaise with project teams to resolve any issues identified with the documents submitted.
• Assist CPL by tracking compliance to all study level plans and escalating any variances.
• Serve as system expert and point of contact for business technologies used during the study (e.g., EDC, Investigator Portal, TMF).
• Ensure CRA compliance with the study parameters via review of monitoring visit reports.
• Track escalation and closure of action items noted in the monitoring visit reports.
• Ensure registration of a protocol in ClinTrials.gov/EUdract and monitor its update throughout a study's life cycle for compliance with the regulations and SOP.
• Act as central point of contact for vendor providing this service.
• Assist CPL with Interactions with CRO and site staff to adhere to study budgets.
• Requests accruals, and performs contract and invoice review.
• Participate in operation meetings with CRO, and cross-functional team members; document escalations and actions.
• Coordinate study team training in the investigator portal; monitor site/CRA user access and track compliance during the study.
• Coordinate with CPL and cross-functional team to assemble study documents as appendices for CSR at study close-out.
• Upon site closure, prepares subject files, inventories documents, reconciles document discrepancies, and organizes study files for electronic archive and off-site storage.
• SME for initiatives in conjunction with the CoE, as required to ensure consistent implementation of best practices across all studies and within a franchise.
• > 3 years of clinical research experience, in the pharmaceutical industry with a solid understanding of technology and processes used in drug development.
• Work with CROs and vendors to drive timelines and deliverables.
• Experience working with study budgets and forecasting; contract and invoice review.
• Research certification desirable.
Competencies • Accountability • Collaboration • Decision Quality • Perseverance • Problem Solving • Drive for results • Informing • Peer Relationships • Time Management • Process Management • Action Orientated • Dealing with Ambiguity
Education: Education • Bachelor's degree or equivalent in one of the disciplines related to clinical practice/health care, life sciences, or drug development.
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