Proclinical Staffing |

1 month ago

cambridge, United States Proclinical Staffing Full time

(Sr.) Director, Clinical Operations - Permanent - Cambridge, Remote

Proclinical is working alongside a biotech company seeking a (Sr.) Director, Clinical Operations to lead and manage clinical trials within early-stage programs. This role focuses on overseeing studies from startup to completion, ensuring operational excellence, and contributing to study documentation. You will collaborate with various departments to develop high-quality, feasible clinical trial protocols and manage budgets effectively.

This is a remote role with occassional travel.

Primary Responsibilities:

The successful candidate will ensure operational excellence and contribute to study documentation.

Skills & Requirements:

  • Extensive knowledge of clinical trial processes, regulatory requirements, and management systems.
  • Strong leadership and team management skills.
  • Excellent communication, collaboration, and interpersonal skills.
  • Ability to work collaboratively with internal and external stakeholders.
  • Ability to manage multiple priorities with aggressive timelines.
  • Excellent analytical and organizational skills.
  • Working knowledge of project management principles and practices.
  • Strong knowledge of global regulatory requirements, ICH guidelines, and GCP.
  • Proactive problem-solving skills.
  • Creative solutions for issues impacting timelines and budgets.

The (Sr.) Director, Clinical Operations' responsibilities will be:

  • Lead and manage clinical trials from startup to completion.
  • Oversee enrollment, data cleaning, and clinical study report writing.
  • Partner with Clinical Development, Biostatistics, Data Management, Drug Safety, Legal, Finance, CMC, Project Management, and Regulatory teams.
  • Influence development team thinking for high-quality clinical trial protocols.
  • Contribute to study documentation including protocol, informed consent, clinical monitoring plan, EDC, and statistical analysis plan.
  • Develop and manage clinical trial budgets.
  • Provide regular updates on trial progress to senior management and stakeholders.
  • Identify and mitigate clinical study risks.
  • Facilitate completion of contracts, clinical trial agreements, and budgets.
  • Aid in determining regulatory strategy and preparing submissions to regulatory authorities.
  • Provide direction and leadership in CRO and vendor selection, management, and oversight.
  • Ensure compliance with SOPs, GCP, and ICH guidelines.

If you are having difficulty in applying or if you have any questions, please contact Nico Kohlwes at n.kohlwes@proclinical.com

Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.

Proclinical Staffing is an equal opportunity employer.

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