FunctionClinical Trials / Research
¥8 - 11m
Our Client is a bio pharmaceutical company.
1. Provide local study management support for assigned global clinical study or studies that include Investigational sites in Japan
- • Oversees/supports the GPL for agreed upon study level timeline for Japan
- • Support the GPL with strategic selection of sites in Japan
- Oversee the country level enrollment plan
- Assist the GPL to track study level budget
- Supports the GPL ensure regulatory compliance and GCP compliance at the study level
- Supports the GPL in the vendor selection.
- Contributes to development of the global vendor oversight plan.
- Assist the GPL with tracking and documenting information related to oversight activities, as agreed upon in the plan.
- Collaborate with Global Clinical Supply and Logistics team and the CRO to plan and coordinate IMP and non-IMP supplies
- Maintain good communication and working relationships with investigators, internal stake-holders and external services providers
- Participate in internal CET meetings as required.
- Support the GPL to track key study level issues, ensuring clear accountability and full resolution of action items – reports to GPL
- Implement approved communication plans with external strategic partners or CROs
- Support the GPL to collect key study performance information, including study start-up metrics, enrollment, data collection timeliness/quality
- Assist and support the global study team in the management of the CTN preparation
- Support the study close out activities through completion CSR
- Participate in multidisciplinary project teams requiring clinical input as required
- Contribute to the global clinical study risk management plan from a clinical operations perspective
- In collaboration with the GPL, identify quality issues within the study through regular review of the clinical team communications including site communications, monitoring visit reports, data flow information and quality assurance audit findings.
2. Provide clinical study oversight of investigational sites to ensure quality and compliance at the site level
- Support the GPL in the site selection process
- Ensure that the approved monitoring plan is consistently executed
- In consultation with the GPL, proactively conduct quality assessment visits and co-monitoring visits of agreed upon sites to ensure high quality study performance, accurate data, and compliance with ICH GCP, SOPs and regulatory requirements
- Ensure audit readiness at the study sites, and follow up corrective/preventive actions
- Implement and lead regional study management meetings
3.Maintain up to date knowledge of applicable ethical and regulatory requirements for the designated region.Maintain up to date knowledge of the therapeutic area/product candidate(s); clinical practice, competitors, and regulatory considerations.4. Follow standard processes, tools and procedures are used consistently for study execution5. Responsible for resolving regional study management issues under the guidance of the study team.6. Manages one or more clinical studies across therapeutic areas with supervision from the Head of Clinical Development Operations Japan.
- A degree (BSc/MSc or equivalent in life science, nursing, pharmacy, medical laboratory technology, or other health/medical related area preferred.
- Other degrees and certifications considered if commensurate with related clinical research experience (e.g., diploma or associate degree RN, certified medical technologist).
Desired Attributes - The following are considered desirable:
- As a guide, a minimum of 4+ years’ relevant clinical research (or related) experience within the pharmaceutical industry.
- A solid understanding of the drug development process, and specifically, each step within the clinical trial process.
- Experience in supporting the execution of global clinical trials (pharmaceutical or research institute).
- Budget forecasting and tracking.
- Thorough knowledge of ICH guidelines/GCP and its applicability to all stages of the clinical development process
- Postgraduate qualifications.
- Knowledge of use of project management software packages
- Experience in scientific/medical research.
- Specialist knowledge e.g. immunology, coagulation disorders, pulmonology, virology, oncology and cardiology.
- Potential or demonstrated ability to plan, and support execution and completion of clinical study to the highest ethical and scientific standards
- Ability to lead teams and work in a fast-paced team environment.
- Experienced in working within a Matrix Environment
- Excellent interpersonal and decision making skills. Demonstrates innovation. Possesses drive, energy and enthusiasm to deliver the program objectives.
- Excellent understanding of all tasks involved in a clinical study from developing a protocol through to finalizing a clinical study report.
- Demonstrated ability to comprehend complex scientific concepts and data. Proficient in reviewing and assessing clinical data.
- Extensive and comprehensive knowledge of ICH guidelines/ GCP. Maintains current medical/scientific/regulatory knowledge.
- Demonstrated project management skills including simultaneous management of multiple studies. Possesses excellent planning, time management & coordination skills.
- Demonstrated ability to problem solve and use clear judgment in relation to regulatory requirements, interactions with external parties, timelines, and complex clinical studies.
- Strong written and verbal communication skills in Japanese and good command of English language
- Ability to manage competing priorities
- Maintains computer literacy in appropriate software.