Senior Clinical Trial Manager - Exciting Small Biotech

Proclinical are recruiting a Senior Clinical Project Manager for an exciting Small Biotech based in central London. This role is on a permanent basis and allows for a flexible hybrid working environment with just up to one day a week in the office.

Responsibilities:

• Guide the study team meetings.
• 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.
• Act as the main point of contact for the CRO covering protocol interpretations, issue intensifications, protocol-specific logistical matters.
• You will quality corroborate the study preparations offered by the CRO through to the study close out.
• To guarantee adherence to scope of work within deadlines and budgets at the general study level, you will be accountable for handling CRO performance.
• Guarantee that the CRO variety is applicable for the study prepared.
• The ideal candidate will handle the production of the Trial Oversight Plan and any other plans that are needed, ensuring faithfulness.
• Follow study milestones and oversee general functional performance metrics through the study's life cycle.
• 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.
• Guarantee that the Trial Master File is maintained.
• For all clinical studies, you will offer senior guidance with updates on the process, modifications in scope and resource needs in a timely manner.
• To guarantee clinical studies are handled in a strong regulatory and functional framework, you will participate in the improvement and application of process.
• Work alongside any other important functions to preserve audit and guarantee it's ready for inspection.
• Any other duties to be assigned to the role.

Skills & Requirements:

• Educated to a degree level within an applicable subject or previous experience operating as a Registered Nurse.
• 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.
• High attention to detail.
• Can handle multiple projects simultaneously.
• 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 Dove Jociute at +49 69 506077052.

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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