Description:
Some opportunities happen only once in a lifetime - like a job where you have the chance to change lives. At Alexion, people living with rare and devastating diseases are our Guiding Star. We are driven to continuously innovate and create meaningful value in all we do to help patients and families fully live their best lives. We value the uniqueness and diversity of our employees and recognize that nurturing the diverse perspectives and strengths of our people translates into innovative breakthroughs for patients.
This Is What You Will Do
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.
You Will Be Responsible For
- Customizing/updating 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.
- Ensuring 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.
- Assisting CPL by tracking compliance to all study level plans and escalating any variances.
- Serving as system expert and point of contact for business technologies used during the study (e.g., EDC, Investigator Portal, TMF).
- Ensuring CRA compliance with the study parameters via review of monitoring visit reports.
- Tracking escalation and closure of action items noted in the monitoring visit reports.
- Ensuring registration of a protocol in ClinTrials.gov/EUdract and monitoring its update throughout a study’s life cycle for compliance with the regulations and SOP.
- Acting as central point of contact for vendor providing this service.
- Assisting CPL with Interactions with CRO and site staff to adhere to study budgets.
- Requesting accruals and performs contract and invoice review.
- Participating in operation meetings with CRO, and cross-functional team members; documenting escalations and actions.
- Coordinating study team training in the investigator portal; monitoring site/CRA user access and tracking compliance during the study.
- Coordinating with CPL and cross-functional team to assemble study documents as appendices for CSR at study close-out.
- Upon site closure, preparing subject files, inventories documents, reconciling document discrepancies, and organizing 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.
You Will Need To Have
- >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.
- The duties of this role are generally conducted in an office environment. As is typical of an office-based role, employees must be able, with or without an accommodation to: use a computer; engage in communications via phone, video, and electronic messaging; engage in problem solving and non-linear thought, analysis, and dialogue; collaborate with others; maintain general availability during standard business hours.