Precision for Medicine CRO have a fantastic opportunity for a Director/Senior Director to join our Clinical Operations team in Europe. Join our growing team in this pivotal leadership role! This role is a second line management position, overseeing several European countries within our Clinical Monitoring group. Please note we may consider an Executive Director level depending on experience.

Precision for Medicine is a precision medicine CRO. Precision’s uniquely integrated offering enables the science of precision medicine by combining novel clinical trial designs, industry-leading operational and medical experts, advanced biomarker and data analytics solutions, and an unequivocal real passion for rare diseases and oncology, in addition to working across other therapeutic areas.

This position can be based working remotely in the UK or Spain.

Position Summary

Oversees Clinical Operations (Clinical Monitoring) activities within the Western European region, ensuring studies are conducted in accordance with applicable SOPs, regulations and the principles of ICH-GCP. Introduces and ensures adherence to internal processes that facilitate high standards of service delivery to Precision’s clients and that supports leadership of the Clinical Operations Department.

Essential functions of the job include but are not limited to:

Work with Clinical Operations Leadership to support defined corporate and departmental business strategies for PfM

Ensure Clinical Operations Department personnel work to the highest quality standards and maintain compliance with established SOPs, working guidelines, project plans and all regulatory requirements

Direct, manage and ensure collaboration within a team of Clinical Operations in the planning, execution and governance of clinical activities on a global platform

Provide leadership and oversight on all programs including large programs or programs that are increasingly complex (in scope, revenue contribution, volume) and interact with Project Manager and/or DPM, as representatives of the Clinical Operations function, in the escalation and resolution of clinical study

Optimize the profitability of Clinical Operations Department to meet or exceed budget targets

Partner with Global Resourcing teams for assessment and management of Clinical Operations team members under their remit, to ensure that established cost, time, and quality goals are met

Recruit, train, develop and manage the performance of talent in Clinical Operations Department

Provide technical support and guidance (including scope definition, risk identification, escalation and mitigation, resource planning, goals and deliverables) to assigned Clinical Operations Line Managers

Identify and escalate impacts to project scope, resources, schedule or budget through standard methods

Participate with Business Development in opportunity development, proposals and budgeting, bid defense preparation and meeting attendance

Understand and manage project/program inter-dependencies to achieve program milestones/deliverables

Conduct evaluations and implement required changes for all projects (including mid-project recovery of “at risk” projects, re-scoping, postponement, or cancellation)

Analyse, measure and report KPIs and lead continuous improvement of Clinical Operations function within their remit

Recognize, exemplify and adhere to PfM’s values that centre on our commitment to quality, our people, clients and performance

Be active in the general and strategic management of the business

Manage workload of supervised staff with continued assessment and adjustment as needed

Provide on-going feedback, development and coaching of Clinical Operations Line Managers and individual contributors including via annual performance reviews

Requirements:

Bachelor’s degree or equivalent combination of education/experience in science or health-related field. Advanced degree preferred.

Substantial experience in clinical research, including extensive clinical and line management experience or proven competencies for this position

Expert knowledge of GCP/ICH guidelines and the clinical development process

Experience with Microsoft Office Products (Outlook, Word, Excel, PowerPoint) and clinical software experience (CTMS, eTMF, EDC etc)

Excellent communication and interpersonal skills to effectively interface with others in a team setting

Excellent organizational skills, attention to detail, and a customer service demeanour

Experience in managing clinical aspects of complex and global trials

Ability to travel domestically and internationally including overnight stays

Competencies:

Leads, inspires, and ensures appropriate ownership and accountability in a highly virtual and matrix-managed organization

Working knowledge of clinical operations tools and techniques

Proven experience in people management

Effective mentor and coach with proven ability to identify individual development needs

Proven experience in strategic planning, risk management and change management

Ability to work closely with business unit leadership to understand customers’ needs

Strong analytical skills and business acumen

Executive presence with ability to confidently deliver complex presentations to senior management or clients

High level of integrity and must inspire and demand the highest standards from a professional and ethical perspective

Demonstrated leadership track record and effective interpersonal skills

Ability to lead and inspire excellence within a team

Ability to create an environment where employees have a sense of ownership that will lead to increases in productivity and efficiency

Results oriented, accountable, motivated and flexible

Excellent time management, negotiation, critical thinking, decision making, analytical and interpersonal skills

Focused on continuous improvement, with the ability to make proactive assessments on how to make processes more efficient and people more effective in delivering results with appropriate quality and timeline performance

Excellent presentation, verbal and written communications skills

In depth proven experience in pharmaceutical and/or device research required

Proven experience in delegating while fostering cohesive team dynamics

Demonstrated successful independent negotiation and conflict management strategies

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