EXCELYA, the fastest growing European CRO with 18 offices across Europe, expands its Clinical Operation Department and is looking for an experienced Line Manager to join our team in Greece.
Are you ready to make your next career step and join EXCELYA on its way to become the Leading CRO in Europe?
Purpose of the role:
The FSP Line Manager (FSPLM) ensures that all appropriate administrative and clinical research personnel resources are available for outsourcing to the respective clients’ departments. The FSPLM also sees that the respective outsourced personnel manage their projects within the timelines and budget agreed with the client for a given scope of work. The FSPLM manages all members of the department under his/her responsibility so that all of them perform their respective roles according to the client’s requirements and comply with the applicable international clinical research regulations and the highest standards of quality.
- Is responsible for the management, evaluation and development of supervised staff
- Provides guidance and expert advice in the areas of clinical research regulations and monitoring procedures and supports his/her direct reports to achieve delivery of study objectives
- Assesses resources requirements and allocates members under his/her responsibility accordingly, based on their experience and personal capabilities and coordinates their activities
- Ensures that staff achieves expected quality compliance standards with all appropriate SOPs, policies, regulations and guidelines, and conducts activities detailed in the Quality Oversight Plan applicable for each role (including spot check review of reports and spot co-monitoring for CRAs), and periodic review of CRA processes to ensure maximum efficiency without adversely affecting customer service
- Ensures that supervised staff meets the expected study timelines and deliverables
- Supports direct reports with resolution of significant site issues and development of recruitment strategies
- Supports CRAs as applicable to optimize investigator / site performance
- Provides regular feedback to sponsor’s management about operations of staff
- Acts as point of contact for sponsor
- Reviews and approves expense reports
- Liaises with clients on outsourced personnel – related matters
- Is responsible for delivering the target budget for the Department
Required Skills & Knowledge:
- BSc degree or equivalent in Life Sciences, a post graduate diploma will be considered an asset
- Experience as trial/ line manager or strong background as Lead CRA in project/ people management in Clinical operations/ Prior experience as CRA
- Advanced knowledge and ability to apply GCP/ICH and relevant guidelines, audits and inspections expertise with solid understanding, and implementation of new methodologies in research.
- Ability to present to senior management, to translate company strategy into motivational local practices, to coach/ mentor and develop staff
- Excellent communication and negotiation skills, strong organization skills and attention to detail; Ability to convey messages successfully and build strong professional relationships with stakeholders.
- Self-motivated, able to work effectively under pressure independently and within teams in a highly demanding multinational working environment