Associate Director (remote-based)

Proclinical are recruiting an Associate Director for an exciting Start-Up Biotech. This role is on a permanent basis and allows for remote based working anywhere within the United Kingdom. The client is focused on fabricating life-changing therapies within Inflammation and Oncology.

Responsibilities:

• You will quality validate the study provisions offered by the CRO through to the study shut out.
• Guarantee that the CRO assortment is pertinent for the study organised.
• Follow study milestones and oversee general functional performance metrics through the study's life cycle.
• Guide the study team meetings.
• Guarantee that the Trial Master File is maintained.
• Work alongside any other important functions to preserve audit and guarantee it's ready for inspection.
• Generate a study planning budget and oversee the general approved budget against study progress.
• Offer supervision over the CRO to guarantee compliance with the company's quality procedures.
• Recognise matters in a timely manner and recommend solutions.
• Together with the Project Team and CRO, you will be heading the deliberations on site selection and qualifications.
• Any other duties to be assigned to the role.

Skills & Requirements:

• Educated to a degree level in a pertinent discipline or past experience in a registered nurse role.
• Preferably at a local and global level, possess experience operating in clinical operations within a pharmaceutical industry where the role involved managing projects.
• Amidst all phases of clinical development, you will have solid experience with supplier management and supervising clinical studies and the study teams.
• Acquaintance with a wide variety of clinical operations notions, practices and processes with a solid comprehension of the process and regulations that relate to clinical investigations that involves know-how of EMA/FDA regulatory needs and ICH GCP procedures.
• Strong scientific, operational and regulatory expertise.
• Exhibits familiarity with design and operational management of clinical studies internationally, involving regulatory needs, CRO proficiencies and compliance practices.
• Efficient communication skills both written and verbally when conversing with experts in therapy areas and patient advocacy groups.
• Organisational, planning, and prioritising capabilities with time management skills, especially to fit company needs.
• A self-motivated individual capable of cooperating well with others within the company as well as independently within a dynamic work setting.
• Familiarity with Microsoft Word, Excel, Project, PowerPoint, and any other needed computer applications.
• Capable of comprehending the notions and implementations of clinical research, medical vocabulary, clinical patient management and any other fields related to drug development.
• At ease with vagueness.
• Possess flexibility, capable of implementing originality and autonomy.
• To outline issues, gather and assess, establish facts and suggest resolutions, you will be opinionated and think rationally.
• A high attention to detail with the capacity to handle multiple projects concurrently.
• Build and preserve relationships with colleagues, higher authorities, investigator site staffs and service suppliers.

If you are having difficulty in applying or if you have any questions, please contact Joseph Dwyer-Canton at +44 203 857 3485.

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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