CTM (all genders) Madrid
- Experience Level
- Experienced (non-manager)
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 approximately 900 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.
- Coordinate and manage a pool of CRAs from different countries within a project team
- Manage overall study metrics (data retrieval, site visits, query rate, timelines, etc.)
- Review and/or input to study protocol, CRF and validation tools
- Preparation and/or review of any kind of essential study documents, Monitoring Guidelines, CRF Completion Guidelines, Patient Information and Informed Consent Form, etc.
- Preparation of the submission documents to the Independent Ethics Committees (central and local if applicable) and when applicable to Competent/Regulatory Authorities, Participates to Investigators selection/feasibility: e.g. phone contacts, questionnaire in the appropriate country
- Ensure TMF and ISF set up and maintenance for the countries assigned
- Coordinate Ethics Committee submissions (initial and amendments)
- Assists in developing of Investigator and Institution contracts and budget template, negotiates budgets with sites and arranges site payments
- Coordinate site contracts negotiation
- Organize/coordinate the investigator payments to sites
- Monitoring of CRA visit schedule and ensure CRAs are within the requirements for visits scheduled as per study monitoring plan
- Provide monthly status reports to include (e.g. Regulatory document collection, Site start-up status, Enrollment status, Monitoring visits planning, Monitor visit reports, Drug distribution and inventories, Study materials, Site payments, Number of CRF forms verified, Number of queries sent and resolved by patient and by site)
- Review and approve any kind of site visit reports and follow-up letter and ensure that reports are completed within the timeframe as per SOP/Sponsor agreement
- Monitoring of data metrics with Data Manager to ensure the data is always consistently monitored/source data verified at all times
- Work closely with data management vendor(s) to ensure low query rate and prevent/resolve data trends/problems
- Work closely with lab vendor(s) to monitor problems and trends
- CTM telephone conferences (together with Project Manager if applicable)
- Maintain strong relationship with CRAs, CTAs (Field Employee and Freelancer) and in-house team
- Mentor, train and supervise staff at a functional level
- Perform co-monitoring training with CRAs
- Conduct any kind of site visit in the assigned countries and sites or whenever it is necessary
- Attend investigators meetings for the assigned countries
- Assist CRAs for on-site audits if needed
- Travel as necessary, consistent with project needs
- University degree in sciences or related fields ((e.g. Pharmacy, Pharmacology, Biology, Chemistry, Medicine, Veterinary Medicine) or comparable education
- Experience and solid know-how of CTM tasks (at least 1 year of experience)
- Experience and solid know-how of CRA tasks
- Fundamental knowledge in European regulations, ICH GCP and any further applicable regulatory requirements and legislation governing a conduct of clinical trial in the corresponding country/Linical office.
- Experience and solid know-how of study start-up activities, monitoring activities, preparation and maintenance of study documentation, communication with other departments
- Basic knowledge in project management, drive for results, focus on customers and projects, global orientation /interests and proven expertise in management/financial control fundamentals in the applicable countries
- Know-how of Investigator and Institution contracts, and negotiating budgets
- Extensive know-how and understanding of GCP and the environment of clinical studies
- Self-starting and ambitious attitude to actively drive things forward
- Fluency in English both spoken and written (additional Language is a plus)
- Experience in an international CRO is beneficial
- Friendly, open, motivated and optimistic personality
- Ability to work in a team and independently
- Effective time management and organizational skills
- Communication skills
- Sense of responsibility
- Solid IT – know how about standard PC applications (MS – office)
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.