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Clinical Trial Manager II
3 months ago
When we put unexpected teams in the same room, we unleash bold thinking with the power to inspire life-changing medicines. In-person working gives us the platform to connect, work at pace and challenge perceptions. That's why we work, on average, a minimum of three days per week from the office. But that doesn't mean we're not flexible. We balance the expectation of being in the office while respecting individual flexibility. Join us in our unique and ambitious world.
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 critical issue 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 the TMF specialist 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., site training plan, site monitoring plan, cross functional data review plan, IP release plan etc.
- Assisting the 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 and track critical issue and closure of action items noted in the monitoring visit reports (Late Phase studies only).
- Ensuring registration of a protocol in and monitoring its update throughout a study's life cycle for compliance with the regulations and SOP.
- Assisting CPL with interactions with CRO and site staff to carry out study budgets, requesting accruals, and performing contract and invoice review.
- Participating in operation meetings with CRO, and cross-functional team members; documenting critical issues 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.
- Serving as SME for initiatives in conjunction with the Center of Excellence, as required to ensure consistent implementation of best practices across all studies and within a franchise.
- Bachelor's degree or equivalent in one of the fields related to clinical practice/health care, life sciences, or drug development
- Excellent written and verbal skills and strong interpersonal skills
- Proficiency in Microsoft Office Suite and email.
- 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.
- >3 years of clinical research experience/in the pharmaceutical industry with a proven understanding of technology and processes used in drug development.
- Worked with CROs and vendors to drive timelines and results.
- Experience working with study budgets and forecasting; contract and invoice review.
- Research certification desirable.
Why Join Us?
At Alexion, you will find a collaborative culture that encourages innovation and a diverse environment where your contributions are valued. You will have the opportunity to be at the forefront of rare disease research and make a meaningful difference in patients' lives. Ready to lead and inspire? Apply now and take the first step towards a fulfilling career at Alexion, AstraZeneca Rare Disease.#LI-Hybrid
AstraZeneca embraces diversity and equality of opportunity. We are committed to building an inclusive and diverse team representing all backgrounds, with as wide a range of perspectives as possible, and harnessing industry-leading skills. We believe that the more inclusive we are, the better our work will be. We welcome and consider applications to join our team from all qualified candidates, regardless of their characteristics. We comply with all applicable laws and regulations on non-discrimination in employment (and recruitment), as well as work authorization and employment eligibility verification requirements.
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