Clinical Trial Manager

2 weeks ago

Boston, United States Life Science People Full time

Our client is a leading biotechnology company dedicated to advancing innovative therapies in the fields of oncology, transplantation, and cellular therapy. We are committed to improving patient outcomes and transforming the landscape of medical care through groundbreaking research and development efforts. As we continue to expand our portfolio of clinical trials, we are seeking a dynamic and experienced Clinical Trial Manager to join our team.


Position Overview:

We are looking for a highly motivated Clinical Trial Manager with a minimum of 2 years of experience in biotechnology, particularly in managing oncology, transplant, and cellular therapy trials. The successful candidate will be responsible for overseeing all aspects of clinical trial management, from study initiation to closeout, ensuring adherence to regulatory requirements, protocol compliance, and study timelines. This role offers the opportunity to work in a fast-paced and collaborative environment, contributing to the advancement of cutting-edge therapies that have the potential to make a significant impact on patient care.


Key Responsibilities:

  • Lead the development and implementation of clinical trial protocols, including study design, patient eligibility criteria, and study procedures.
  • Coordinate with cross-functional teams to ensure seamless execution of clinical trials, including site selection, investigator meetings, and study monitoring activities.
  • Oversee site initiation, training, and ongoing support to ensure compliance with study protocols and regulatory requirements.
  • Ensure all clinical trials are conducted in accordance with Good Clinical Practice (GCP), International Conference on Harmonization (ICH) guidelines, and applicable regulatory requirements.
  • Collaborate with regulatory affairs team to prepare and submit regulatory documents, including Investigational New Drug (IND) applications, amendments, and annual reports.
  • Develop and maintain project timelines, budgets, and resource plans to ensure successful execution of clinical trials within scope, budget, and timeline.
  • Identify and mitigate risks and issues that may impact the progress of clinical trials, implementing corrective actions as needed.
  • Work closely with data management and biostatistics teams to ensure accurate collection, management, and analysis of clinical trial data.
  • Review and interpret study results, collaborating with medical affairs and scientific teams to prepare study reports and publications.
  • Oversee relationships with contract research organizations (CROs), central laboratories, and other third-party vendors to ensure quality and timely delivery of services.


Qualifications:

  • Bachelor's degree in life sciences or related field; advanced degree preferred.
  • Minimum of 2 years of experience in clinical trial management within the biotechnology or pharmaceutical industry.
  • Experience in managing oncology, transplant, and/or cellular therapy trials is highly desirable.
  • Strong understanding of GCP, ICH guidelines, and regulatory requirements governing clinical research.
  • Excellent project management skills with the ability to prioritize tasks and meet deadlines in a fast-paced environment.
  • Effective communication and interpersonal skills, with the ability to collaborate effectively with cross-functional teams and external stakeholders.
  • Proven ability to problem-solve and make sound decisions under pressure.
  • Proficiency in Microsoft Office Suite and clinical trial management systems.

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