Director of Clinical Operations – Device, Diagnostics and Manufacturing

We have an exciting opportunity available as a Director of Clinical Operations at a large Contract Research Organization and Consultancy firm. This position will report into the Vice President of Clinical Operations and is responsible for oversight, planning, initiation and execution of device and diagnostic studies.

Responsibilities

• Lead operational aspects of device and diagnostic RFI and RFP preparation.
• Assist in the preparation of internal start up meetings for new projects.
• Work with the Business Development Department on identifying new or expanding opportunities.
• Coordinate, attend, and lead client visits and teleconferences as indicated.
• Oversee or participate in device and diagnostic operational tasks as needed.
• Manage and allocate internal and external resources across device and diagnostic projects based on experience and training. Recognize potential gaps and proactively plan.
• Supervise overall study management by monitoring deliverables, schedules, timelines and external team resources.
• Strategically identify possible improvements to current processes, determine new processes that are needed, and initiate and implement new processes.
• Leads device and diagnostic operations metrics preparation and correct allocation of staff.
• Lead and author training programs for device and diagnostic operations personnel on new processes.
• Serves as a primary or secondary study team contact to manage the operations of device and diagnostic trials, communicating team objectives to ensure quality and success.
• Leads the development of the investigator budget. Ensures effectiveness of site budget/contract process.
• Directs the development of study related documents such as monitoring guidelines, monitoring plan, source document templates, monitoring visit report templates, site tools and worksheets.

Requirements

• Bachelors degree or higher
• Circa 10 years of experience working in clinical research, including time in device and diagnostic operations
• At least two years of experience working as a Clinical Research Associate (CRA/monitor).
• Experience in a leadership capacity including managing direct reports

Following your application Simon Trebilcock, a specialist Medical Recruiter with over 7 years’ experience recruiting in the field will discuss the opportunity with you in detail. He will be more than happy to answer any questions relating to the pharmaceutical industry and the potential for your career growth. The conversation can also progress further to discussing other opportunities which are also available right now or will be imminently becoming available.

This position has been highly popular, and it is likely that it will close prematurely. We recommend applying as soon as possible to avoid disappointment. Please click ‘apply’ or contact Simon Trebilcock for any further information

Email -  strebilcock@planet-pharma.co.uk

Telephone - +44 (0)203 928 6632.

About Planet Pharma

Planet Pharma is an American parented Employment Business/Agency that provides global staffing services with its head-quarters in Chicago and our EMEA regional office located in Central London. We have invested significantly in creating a robust international platform that enables us to work compliantly in 30+ countries with a current network of 2500+ active contractors globally as well as a very strong permanent / direct hire recruitment offering.

Our specialist knowledge and close relationships with our clients and the wider industry really makes us unique in our field. Just recently we were recognised by FORBES as the 17th best professional staffing firm, and have won multiple awards from industry accredited bodies for our commitment to excellence and service delivery. We have extensive functional expertise including: Regulatory Affairs, Pharmacovigilance, QA, QC, Submissions experts, Clinical development, Quality, Biostatistics, and Medical Affairs / Writing.

We are an equal opportunities Recruitment Business and Agency. We welcome applications from all suitably qualified candidates regardless of their race, sex, disability, religion/belief, sexual orientation or age.

www.planet-pharma.com