(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.
