Clinical Operations Manager, Frankfurt ( all genders)
- Experience Level
Linical Co., Ltd. (‘Linical’) is a premier global CRO headquartered in Osaka, Japan, listed in the prime segment of the Tokyo Stock exchange, and dedicated to serve its clients as a true partner in development. With more than 700 employees Linical directly covers a total of more than 20 countries in Europe, North America and Asia-Pacific including Japan via its own offices and staff.
Linical’s European arm is headquartered in Frankfurt, Germany with a substantial presence in Paris and Madrid. Its geographic footprint facilitates a significant presence in the leading Western European markets, combined with well-established affiliate operations in key emerging markets in Central- and Eastern Europe.
We offer individualized solutions that are tailored to the specific needs of our sponsors. We work as integrated teams functioning with maximum transparency throughout each study, making sure that the sponsor is kept up to date on all study parameters and progress. We are dedicated to the highest standards of quality, with a special focus on the therapeutic areas oncology, immunology and CNS, based on experience and expertise.
- Line Management of a Clinical Monitoring Team (CRAs/CTAs)
- Responsible for the recruitment and interview process of Clinical Monitoring Team
- Ensure sufficient resources are in place to meet the business demand
- Maintain a resources planning up to date on a monthly basis
- Determine and prioritize resources assignments i.e. distribution and allocation of CRAs resources per study, per site
- Supervise CRA activities i.e. ensure CRAs team efficacy, quality of work, optimization of CRAs team workload and respect of timelines
- Monthly review of workload (working time and monitoring visits)
- Ensure and supervise the training-on-the-job process of CRAs/CTAs (identify training needs and apply training as applicable in harmonization and arrangement with the Director GCP Training & Compliance Europe)
- Perform co-monitoring with CRAs in harmonization and arrangement with the Director GCP Training & Compliance Europe
- Perform Accompanied Training & Compliance Visits (if needed as deputy, and in harmonization and arrangement with the Director GCP Training & Compliance Europe)
- Perform quality control and implement corrective actions (e.g. review of any kind of site visit reports, site visit follow-up letters, in-house CRFs, TMF filing procedures and maintenances)
- Setting objectives of the Clinical Monitoring Team
- Performance evaluation of the Clinical Monitoring Team
- Annual appraisal of the Clinical Monitoring Team
- Ensure professional development of the Clinical Monitoring Team in harmonization and arrangement with the Director GCP Training & Compliance Europe Interface with other departments
- Review for approval of CRFs, monitoring guidelines, validation tools etc.
- Realization of CRA external allocation (outsourcing)
- Involvement in the study budget preparation and in the preparation of monthly billing tasks, expenses and budget follow-up
- Provide input in the negotiation of contracts with clients in order to assure that the requested services are feasible within staffing, budgetary and timeline constraints
- Development and review of relevant SOPs for Clinical Drug Development Interface with sponsors, when needed
- Review of literature, legal provisions concerning conduct of clinical trials etc. in terms of self-reading training and training of other team members of the company in new aspects of clinical research
- Participate in relevant job related trainings
Familiar with the principles of ICH GCP, SOPs and any European/global (depending on the study) applicable regulatory requirements and legislation (e.g. Competent Authorities, Health Authorities, Ethics Commitees) governing the conduct of clinical trials. In addition the COM shall have a proven record and extensive experiences of e.g. study start-up activities, any kind of monitoring activities, preparation and maintenance of study documentation, communication with other departments as well as knowledge in project management, drive for results, focus on customers and projects, global orientation / interests and proven expertise in management / financial control fundamentals, negotiation skills and awareness of legal and contract issues, talent at presentations, extensive acumen in problem solving, team and to mentor commitment to quality, interpersonal savvy, ability to build a, direct and motivate staff, and adequate Line Management experiences.
Fluent written and oral English skills. Familiar with MS Office tools.
- Team player with ability to work independently in an international environment
- Effective time management and organizational skills
- A demonstrated ability for training, including coaching and mentoring
- Communication skills
At Linical, we embrace the opportunities and possibilities that are held by diversity, equal opportunity and inclusion. We value bringing together individuals from diverse backgrounds regardless of race, disability, ethnicity, gender, sexual orientation or any other legally protected characteristic. Linical will consider all candidates that match with the requirements of the position, promoting diversity and equal opportunity for all.