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.