Management & Development
- Spearhead operations (kit building, accessioning, sample storage, project management) within the EMEA organization and take full top-level responsibility.
- Work closely with the leadership team to define EMEA operational strategy and direction.
- Continue to build a high performing Good Clinical Practices (GCP) team with a culture of operational excellence and continuous improvement.
- Play a key role in directing future growth and success of the EMEA organization in close alignment with global stakeholders.
- Team Leadership: Lead, mentor and develop a high-performance clinical operations team. Foster a collaborative and results-driven culture to support clinical trials.
- Supervise, coach, develop, and retain talented associates.
- Operational execution: drive cross functional collaboration with global functional leaders, QA, Business development, finance and logistics.
- Oversees EMEA book of work to uphold project delivery reliability and efficiency, especially for, but not limited to, the achievement of deliverables on time and on quality.
- Act as point of contact for escalations and identify risks and remove barriers to finding solutions
- Proactively manages client relationships and issues and makes recommendations for related
process enhancements and business process optimization.
- Maintains contact with key clients to ensure satisfaction levels, monitors customer surveys,
identify areas for improvement.
- Develop and execute regional staffing strategy to meet the needs of the organization
- Direct supervision of (Sr.) Project Management Managers, Clinical Trial Materials Lead, Sample Management Lead, and other key staff as defined.
- Ensure that staff maintain effective and productive communication and working relationships with all departments.
- Meet with directors and other (Sr.) managers/supervisors to stay informed of changes affecting operations.
Quality
- Develop and document standard regional standard operating procedures aligned with organizational SOPs and global/regional regulatory requirements.
- Support investigation and resolution of regional quality events related all the areas of the EMEA Operations
- Ensures that all organizational activities and operations are carried out in compliance with local,
national and EU regulations and laws governing business operations, and with adherence to
- procedures and compliance.
- Consistently evaluates metrics, guides actions to be taken based on metrics data to enhance
services, quality, and profitability.
- Liaises with the Quality and Regulatory Services (QRS) department to ensure vendors are
qualified/re-qualified and assist with issue resolution.
Operations
- Responsible for overseeing the smooth running of project deliverables conducted throughout the EMEA Operations.
- Create, track, report, and analyze functional KPIs with orientation to action.
- Responsible for budget achievement.
- Serves as a critical escalation point of contact for management issues related to clinical trials.
- Oversee teams’ participation in internal quality assurance unit.
Finance
- Perform ongoing project and operational profitability tracking and analysis.
- Maximize the profitability of LabConnect Service Fees to meet or exceed budgeted profitability.
- Responsible for taking a proactive approach to collaborate with Finance to formulate operational and economic projections and budget expectations.
- Proactive study management based on conditions, operational projections, and economic budget forecasts to include ensuring members of the departments work according to the schedules and timelines established by the Sponsor.
- Liaise with LabConnect management and key Vendor Laboratories to identify and implement opportunities for standardization of processes and increase efficiency within and between our organization and departments.
External/Industry
- Interfaces with laboratory, customer service, business development, external project management, and information technology, logistics and data management personnel.
- Leadership to ensure appropriate communication channels are maintained and reporting schedules are adhered to.
- Represents LabConnect at client meetings and industry conferences.
- Performs other related duties and tasks as necessary or as assigned.
Education/Experience
Bachelor of Science in a Life Science discipline, MBA also desirable withat least 5-year experience in Clinical Operations, managing clinical trials and/or Laboratory services. Demonstrated experience in senior leadership roles including establishing RACI and communication channels.
Skills Required
- Dynamic leader with proven experience successfully leading a team on global trials.
- Proven track record of successfully leading and developing teams.
- Skilled in working collaboratively with senior management teams, as well as pharmaceutical-, biotech- and CRO companies.
- Experienced in customer service and possess excellent organization and interpersonal skills.
- Ability to navigate software and databases.
- Adaptive to change, and excellent problem-solving and multi-tasking skills is required for success in this position.
- Willing to work onsite at one the main location in Swalmen or Cologne.
Language Ability
Fluently in English and one other European language (with preference for German).
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