Precision for Medicine CRO have a fantastic opportunity for a Senior Director or Executive Director to join our Clinical Operations team in Europe. Join our growing team in this pivotal leadership role!

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.

We offer flexible location options, and remote based working. This position can be based in one of the following countries: UK, Spain, Poland, Hungary, Serbia or Romania.

Position Summary:

• Responsibilities are focused on the operational and strategic leadership, and career development of the organization’s clinical operations workforce in Europe, as well as leading the development of departmental initiatives to strengthen the quality and productivity of clinical operations.
• The SD / ED, Clinical Operations is responsible for financial and quality aspects of the assigned hierarchy.
• Second line management, overseeing Clinical Monitoring line managers within a region, ensuring standards consistent with Precision for Medicine’s values and overall focus on quality. Specific focus will be to ensure the right resources are assigned to projects and that those resources have the tools necessary to be successful and staff achieve the required levels of quality and productivity. In addition, this position will ensure career development and support, to minimize turnover and maintain high levels of employee satisfaction.

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

• Ensure the development and implementation of action plans and provide developmental/strategic oversight to optimize activities, with a focus on high quality delivery and productivity of individual/team/departmental goals.
• Manage regional/therapeutic area project resourcing to ensure proper level and allocation resource is assigned for each project within a region/area.
• Collaborate with other groups to ensure that resource needs and site requirements are met appropriately.
• Develop, mentor, manage and coach Managers to progress their skills so that Precision for Medicine quality standards are maintained. Advocate individual career development, and individual responsibility/accountability.
• Oversee department quality performance within the assigned hierarchy and implement actions to correct negative trends.
• Ensure the identification of quality risks and issues and recommend/implement corrective action plans as needed to leadership team to address deficiencies in performance of employees.
• Ensure that all staff have the proper resources, training, materials, and access to systems to deliver on the expectations of their position.
• Ensure staff within the assigned hierarchy provide timely and accurate updates of all required administrative material (SOPs, T&E, etc.) on company systems.
• Work with the Clinical Operations Management Team to continually improve and enhance CRA expectations and procedures to promote quality, consistency and efficiency in execution.
• Develop and maintain metrics pertinent to CRA resource oversight, and work with Clinical Operations Management Team on the evaluation of these metrics.
• Partner with Talent acquisition to ensure adequate levels of candidates and ad-hoc interview process to select high quality staff.
• Ensure appropriate on-boarding training for new GCM staff in conjunction with Human Resources, Clinical Training and other functional areas.
• Secondary responsibilities include assisting with the planning, assigning, and directing of work as well as gathering performance feedback to contribute to appropriate action plans.

Qualifications:

• Graduate, postgraduate or equivalent experience in the industry and clinical operations leadership.

Other Required:

• At least 12 years or more in clinical operations either in CRO or Pharmaceutical industry with a minimum of 5 years onsite monitoring experience.
• Monitoring experience includes use of electronic data capture systems as well as paper and electronic medical records.
• 6+ years of direct supervisory experience managing CRAs and CRA Managers is expected in candidates for this position including:
  • Experience creating effective development programs for clinical staff.
  • Experience developing evaluation processes, performing gap analysis, and ensuring all clinical staff are properly trained to perform their duties consistent with Precision for Medicine quality standards.
• Ability to drive and availability for domestic and international travel including overnight stays, with an expectation of travel approximately 25%.

Competencies:

• Demonstrates mastery knowledge of ICH-GCP, applicable local regulatory requirements, relevant Precision for Medicine SOPs, technical CRA knowledge of all phases of study (including remote monitoring and clinical data review) as well as regulatory guidance.
• High capacity for Emotional Intelligence and a passion for people management and development.
• As part of overall line management responsibilities, ability to develop training plans and hold personnel accountable to achieving training goals or addressing training needs.
• Deep knowledge of how clinical research centers operate along with the ability to teach CRAs and GCM Managers to solve site and execution related problems at the site and project level.
• Demonstrates understanding and ability to work with EMRs and EDCs.
• Exhibits high self-motivation and is able to work and plan independently as well as in a team environment.
• Motivates other members of the project team to meet timelines and project goals.
• Highly organized, ability to set priorities and possesses excellent problem-solving skills.
• Focuses on continuous improvement, including the ability to make proactive assessments on how to make processes more efficient and people more effective.
• Understands clinical trials methodology, including a working knowledge of protocols and indications being studied.
• Ability to develop, coach and mentor CRA and GCM Management staff.
• Ability to delegate and organize the collective work within the assigned hierarchy.
• Ability to negotiate difficult matters.
• Recognized as influential leader within GCM organisation.
• Ability to represent the company at external events, conferences.
• Ability to interact with executive management.
• Demonstrates a high degree of professionalism, as evidenced by punctuality, ability to deliver on commitments, an understanding of the service culture and positive interactions with customers and teammates, including good interpersonal skills.
• Communicates both verbally and in written form in a professional manner.
• Conducts formal presentations to a wide variety of audiences including colleagues, investigative staff, and clients with a high level of proficiency.
• Possesses practical knowledge of IT tools and systems in use on project teams.
• Values system and work ethic consistent with Precision Values and Company Principles

Precision medicine is revolutionizing the attack on cancer—and we are passionate about helping you harness its power. We strike tumors on a molecular level using biomarkers to link specific mutations to specific treatments. We combine deep science with deep data from advanced technological platforms, then layer on specialized expertise in the design and execution of targeted, adaptive clinical trials. Ultimately, we deliver robust insights that inform real-time decisions—and optimize the oncology development pathway.