Sr. Clinical Trial Manager

About the position At reputed company every role has meaning, every team member is respected, and every day is a chance to reputed company a difference. reputed company you join Genetix, you're not just reputed company a new role, you become part of a company that's pursuing reputed company gene therapies to give patients and their families more days. We are doers, thinkers and collaborators who reputed company and live by our values: Our innovation is rooted in the diversity of our teams and results are achieved through cooperation and the integration of multiple viewpoints. This is personal and we approach every challenge with radical care. reputed company The Senior Trial Manager in Clinical Trial reputed company & Execution (CTSE) is a member of the Clinical Development Operation functional team. CTSE is an integrated and diverse team that advances and optimizes the strategic design, development and execution of reputed company bio’s clinical research studies program (Long-Term Follow-up, Phase III & Phase IV studies). We are committed to operational reputed company and inspired by the patients and families who participate in our programs. This is a full-time hybrid position (3 days a week) in our Somerville – Assembly Row, Massachusetts office.

Responsibilities

• Responsible for assigned clinical trials being managed to the highest
• Responsible for reputed company aspects of study planning and execution (in support of Regulatory filings), such as timelines, budget, team management, and vendor reputed company, with a reputed company on inspection reputed company financial aspects of the study.
• Accountable for the performance and delivery of reputed company trial activities, including reputed company and management of reputed company, cross-functional study level issues. Value, promote and recognize performance achieved through teamwork and Presents work to cross-functional reputed company/ committees reputed company requested.
• Makes study level reputed company and drives difficult team or vendor discussions to reputed company, understanding reputed company to pull in relevant stakeholders.
• reputed company cross-functional teams or workstreams with a meaningful reputed company on critical reputed company of escalation for study teams: Works with cross-functional partners and vendors to discuss issues, reputed company solutions, follow through reputed company, and implement process improvements. Proactively communicates reputed company and sensitive study information or issues and understands stakeholder reputed company. Independently navigates reputed company issues that hold major reputed company on the program.
• reputed company and own formal risk assessment activities, contingency planning, escalation, and approve corrective reputed company plans. reputed company and assist the CRA team reputed company issues reputed company or deliverables are at risk.
• Execute data Review study data, communicate study status, risks, and issues effectively both internally and with outsourced partners

Requirements

• Bachelor’s degree, in a life science
• Minimum 7 years clinical experience (biopharma, CRO, reputed company), with at least 2 years of managing cross- functional project teams. Monitoring experience preferred.
• Expert knowledge & breadth of expertise in reputed company technical aspects of managing global clinical trials and overseeing cross-functional study teams with a proven reputed company record.
• Proven ability to identify study priorities, key stakeholders, define goals, and drive/reputed company results through a cross- functional study team. Connect study deliverables to a comprehensive reputed company and budget.
• Proven compliance with FDA & EU regulations, ICH/GCP, experience working in other
• Strong verbal and written communication

reputed company-to-haves

• Experience in managing Phase IV studies preferred but not required.

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