- Coordinates country cross functional teams and acts as the main point of contact for a Country with the protocol manager and other global study team members.
- Coordinates with other internal roles in country and site feasibility process, including proposal and validation of country study targets.
- Develops country level patient recruitment strategy & risk mitigation. Coordinates and ensures country level study enrolment targets and timelines are met.
- Leads problem solving and resolution efforts including management of risk, contingencies, issue resolution and escalation to the appropriate stakeholder/s.
- Assessment and set up the of vendors during study start up period (locally)
- Investigator Meeting participation and preparation.
- Ensures data entered in Clinical Trial Managements Systems is current and complete and access to eDC and vendor systems is available for the Country and clinical trial site personnel.
- Validation of study related materials (i.e. protocol, ICF, patient material).
- Responsible for preparing country specific documents (e.g. global country specific amendment).
- Prepares materials for Site Initiation Visits.
- Responsible for verifying and confirming with local team eTMF completeness (Country and Site level).
- Reviews Site Monitoring visit reports, takes action within the timelines specified and escalates issues and ensures appropriate documentation of issues.
- Coordination of database locks and query follow up. Ensures timelines are met.
- Ensure inspection readiness of assigned trials within country. Provide support to Health Authority inspection and pre-inspection activities.
- Coordinates, develops and writes the Corrective Actions / Preventive Actions (CAPA) and ensures implementation for Country audit level findings. Drives CAPA review, implementation and completion.
- Lead study team meetings locally.
- Reviewing and approving payments (based on GOA) and manage patient compensation claims (if applicable).
- Management of Site relationships (includes CRO related issues).
- May conduct Pre-Study Evaluation Visits (PSEVs) and Site Initiation Visits (SIVs).
- May perform site closure activities, including post-close out.
- May act as point of contact for Sites.
- May support preparing submissions to and obtaining approval from local Health Authorities, Ethics Committees and other relevant instances.
- Engage with Protocol Manager, line management and/or Head of Clinical Operations to assist in the resolution of complex issues both locally and/or globally.
- Serve as a key resource for colleagues, by providing guidance, leading training and mentoring to other team members through a mentoring process using informal and/or formal presentations.
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Sr. Clincial Trial Manager - Shanghai, 中国 - Bristol Myers Squibb
描述
Working with Us
Challenging. Meaningful. Life-changing. Those aren't words that are usually associated with a job. But working at Bristol Myers Squibb is anything but usual. Here, uniquely interesting work happens every day, in every department. From optimizing a production line to the latest breakthroughs in cell therapy, this is work that transforms the lives of patients, and the careers of those who do it. You'll get the chance to grow and thrive through opportunities uncommon in scale and scope, alongside high-achieving teams rich in diversity. Take your career farther than you thought possible.
Bristol Myers Squibb recognizes the importance of balance and flexibility in our work environment. We offer a wide variety of competitive benefits, services and programs that provide our employees with the resources to pursue their goals, both at work and in their personal lives. Read more: .
Senior Level Expectations:
Uniquely Interesting Work, Life-changing Careers
With a single vision as inspiring as "Transforming patients' lives through scienceTM ", every BMS employee plays an integral role in work that goes far beyond ordinary. Each of us is empowered to apply our individual talents and unique perspectives in an inclusive culture, promoting diversity in clinical trials, while our shared values of passion, innovation, urgency, accountability, inclusion and integrity bring out the highest potential of each of our colleagues.
On-site Protocol
BMS has a diverse occupancy structure that determines where an employee is required to conduct their work. This structure includes site-essential, site-by-design, field-based and remote-by-design jobs. The occupancy type that you are assigned is determined by the nature and responsibilities of your role:
Site-essential roles require 100% of shifts onsite at your assigned facility. Site-by-design roles may be eligible for a hybrid work model with at least 50% onsite at your assigned facility. For these roles, onsite presence is considered an essential job function and is critical to collaboration, innovation, productivity, and a positive Company culture. For field-based and remote-by-design roles the ability to physically travel to visit customers, patients or business partners and to attend meetings on behalf of BMS as directed is an essential job function.
BMS is dedicated to ensuring that people with disabilities can excel through a transparent recruitment process, reasonable workplace accommodations/adjustments and ongoing support in their roles. Applicants can request a reasonable workplace accommodation/adjustment prior to accepting a job offer. If you require reasonable accommodations/adjustments in completing this application, or in any part of the recruitment process, direct your inquiries to . Visit to access our complete Equal Employment Opportunity statement.
BMS cares about your well-being and the well-being of our staff, customers, patients, and communities. As a result, the Company strongly recommends that all employees be fully vaccinated for Covid-19 and keep up to date with Covid-19 boosters.
BMS will consider for employment qualified applicants with arrest and conviction records, pursuant to applicable laws in your area.
Any data processed in connection with role applications will be treated in accordance with applicable data privacy policies and regulations.
