(Sr.) Clinical Trial Manager - Permanent - Boston
探花合集 is working alongside a pharmaceutical company seeking a Clinical Trial Manager (CTM) or Senior Clinical Trial Manager (Sr. CTM) to ensure the delivery and execution of clinical studies.
Primary Responsibilities:
The successful candidate will oversee and interact with CROs and other external vendors to ensure studies are conducted according to timelines, budgets, and objectives. You will be accountable for the overall trial conduct, contributing to operational strategy, and managing timelines, budgets, quality, and risk assessment.
Skills & Requirements:
- Strong communication, collaboration, and interpersonal skills.
- Ability to work collaboratively with internal and external partners in a global environment.
- Ability to manage multiple priorities with aggressive timelines.
- Excellent analytical and organizational skills.
- Working knowledge of project management principles and practices (PMP certification is an advantage).
- Knowledge of current global regulatory requirements and ICH guidelines.
- Proactive problem-solving skills and initiative.
- Creative solutions for issues impacting timelines and budgets.
- Bachelor's degree (or equivalent) in a relevant scientific field preferred.
- Experience in the life sciences industry, with clinical trial management experience.
- Experience in the Neuroscience therapeutic area within global clinical trials preferred.
The (Sr.) Clinical Trial Manager's responsibilities will be:
- Lead planning and communication with cross-functional teams for clinical trial execution.
- Oversee performance of CROs, third-party vendors, and contractors to ensure compliance with study protocols.
- Drive critical clinical trial activities including site activations, recruitment, and database lock.
- Review and approve study-related plans generated by CROs and vendors.
- Represent and lead the study team to design, develop, and deliver trials on agreed timelines.
- Identify issues, propose solutions, and assess potential risks with mitigation plans.
- Act as a key liaison between the project team and stakeholders, communicating project status and progress.
- Provide periodic status reports on study timelines and accruals.
- Develop and manage critical study documents and plans.
- Assist the study team with preparation for audits and inspections.
- Maintain project dashboards, Gantt charts, finance systems, and documents to track progress.
- Manage interdependencies and connections between study-level functions.
- Facilitate cross-functional study team meetings, preparing agendas, presentation materials, and meeting minutes.
- Support the planning and preparation of documents for Regulatory/Health Authority submissions.
- Work effectively in a global and virtual environment with an international team.
- Oversee the setup, maintenance, and closeout of the Trial Master File, ensuring it is inspection ready.
If you are having difficulty in applying or if you have any questions, please contact Nico Kohlwes at n.kohlwes@proclinical.com
探花合集 is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.
探花合集 Staffing is an equal opportunity employer.
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