- Responsible for execution of all clinical trials and project management of all clinical activities.
- Lead the global clinical organization, including mentoring and developing clinical team members to foster individual growth and promote internal talent
- Provide management support and leadership in the design, development, implementation and successful execution of clinical studies and processes
- Provide leadership and direction for significant deviation events that may impact compliance status or significant business risk
- Contribute to the development of integrated Clinical Regulatory Strategy through cross functional collaboration with R&D, Regulatory Affairs, Quality and Executive teams.
- Present to the Executive Team and Board of Directors, when needed, all updates and short- and long-range planning for clinical functions.
- Ensure that goals and objectives of the clinical program are met by providing tactical input into the planning and execution of clinical trials.
- Prepare clinical study plans and ensure studies are completed on time and within approved budget, and conducted and monitored in accordance with GCP/ICH requirements.
- Support the Head of Clinical Operations with clinical trials, including selection, contracting, and management of sites. Facilitate communication with contract service providers on study related matters.
- Forecast investigational product needs
- Manage Global Clinical budget, forecast, and resource allocation
- Oversee the preparation of clinical study documents, including Protocols and Amendments, Investigator's Brochures, Informed Consent Forms and Clinical Study Reports.
- BS degree in scientific discipline, MS preferred
- Extensive experience at senior level in Strategic Clinical development
- Clinical leadership experience within medical devices successfully running both European and US studies
- Working knowledge of ICH/GCP guidelines, FDA and EMA regulations
- Clinical trial design and management
- Risk management in clinical trials
- Working within a small and / or start-up organization
- Working with or in hospital clinical trial structures
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Global Head of Clinical Operations - Boston, United States - VIDA Connected Specialists
3 weeks ago
Description
Global Head of Clinical Operations - Neuro
Remote based: East Coast, but will consider Mid-West or West Coast if exceptional
VIDA continue to partner with a pioneering start-up in the field neurostimulation.
To align with our clients clinical strategy we are now seeking a highly experienced clinical leader with experience in the field of stroke, neurology or neurostimulation clinical trials.
Start up experience being a big plus
Function:
Full strategic and leadership responsibility for the Clinical division. Management of the overall clinical development strategic programs, clinical trials and related activities.
Full alignment with the Executive and Commercial Team on business objectives.
Responsibilities:
Assurance of clinical trial conduct in accordance to all regulations (e.g. regulatory guidelines,
national/international standards).
Essential Experience:
Desirable Experience:
Reach out to James Gillman at VIDA - or apply via the posting.
