An exciting job vacancy has emerged for a freelance CRA Line Manager to join one of the world's largest global CROs. This contract research organisation provides support services to many of the biggest names in pharmaceuticals, biotech, medical devices and health care, and has helped to commercialise many leading therapies. This position will be based at their site in Belgium.
Manage a team of CRA staff within a designated office, country or region in order to achieve patient recruitment targets to high quality standards, at sites. Ensure that the right resources are assigned to projects at the right time and that staff gain the necessary skills to perform their respective job responsibilities to high professional standards. Manage the company's key strategic site relationships to build capability, drive productivity and robust quality management. Achieve customer and investigator satisfaction in line with current strategies.
- Support the formulation of strategies and action plans to maximize delivery of a high quality team/department monitoring service, ensuring achievement of individual/team/department targets, aligning with company strategies.
- With support, ensure sufficient level and profile of resource is recruited for each project. Maintain systems compliance and oversight for effective project delivery. Collaborate with the Clinical Lead/Project Lead to ensure that resource needs and site requirements are met.
- Manage key strategic site relationships in order to build capability, drive productivity and robust quality management in line with site strategy. Be an advocate for these sites within the company.
- Manage, develop, coach, and motivate CRAs to develop their skills to ensure that a high professional standard is achieved and project targets are met. Be an advocate for individual career development.
- Conduct Accompanied Site Visits (ASV's) to develop CRA's skills (e.g. patient recruitment). Support CRA's on solving project specific issues across site portfolio.
- Identify quality risks and issues and suggest appropriate corrective action plans to senior management to prevent or correct deficiencies in performance of employees.
- Share company and customer key business drivers with all CRA staff. Drive decision making in line with these.
- Attend customer meetings, maintain interactions with any local sponsor affiliates.
- Support maximization of profitability by ensuring project objectives and customer requirements are achieved
- Ensure that staff have the proper materials, systems access and training to complete job responsibilities. Provide oversight for the execution of the training plan and mentored training experiences.
- Ensure timely and accurate reporting of required information on company systems.
- Support continuous improvement of monitoring processes to deliver quality, consistency and efficiency in delivery.
- Participate in the selection process for new staff by conducting candidate review and participating in the interviewing process. Conduct on-boarding training for new staff in conjunction with Human Resources and Learning and Development training programs.
- Project a professional impression of the Company and act in accordance with the relevant Pharmaceutical Industry's Code of Practice
- Manage staff in accordance with organization's policies and applicable regulations. Responsibilities include planning, assigning, and directing work; gathering feedback for appraising performance, guiding professional development; rewarding and disciplining employees; addressing employee relations issues and resolving problems. Approve actions on human resources matters in consultation with Human Resources and other relevant departments.
- Perform other duties as assigned.
Education, Skills and Experience:
- Bachelor's degree, preferred in Healthcare or other scientific discipline
- 5 years of clinical trials experience including 2 years' experience in a leadership capacity
- An understanding of general management practices desirable (e.g. The Oz Principle, The 4 Disciplines of Execution); or equivalent combination of education, training and experience.
- Good understanding of the health and research environment, patient pathways through health systems and operational processes at research sites.
- Good knowledge and ability to apply GCP/ICH/applicable guidelines, solid understanding of new methodologies in research e.g. remote monitoring
- Strong management and communication skills (written and verbal), ability to present to senior management.
- Ability to translate company strategy into motivational local practices
- Ability to coach/mentor and develop staff
- Excellent organizational and problem solving skills
- Fluent language skills in Dutch, French and English
Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.
In case you have difficulty in applying or if you have any questions, please call Theodora Savlovschi-Wicks on +44 203 7520 314 or upload your CV on our website www.proclinical.com.
A full job description is available on request.
ProClinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.