Maintain up-to-date knowledge of therapeutic areas and clinical trial requirements relevant to Biogen.
Engage in discussions to provide country-level information on therapeutic areas related to studies and programs.
Provide study information to support and drive global operational strategy.
Manage investigator and site relationships to foster collaboration and high satisfaction.
Lead local activities for country and site selection, ensuring input from local stakeholders.
Act as the primary country-level contact for strategic development and execution of sponsor oversight activities.
Oversee compliance with ICH/GCP and local regulations during Sponsor Oversight Visits and audits.
Serve as the main contact for all QSDO clinical studies, ensuring timely resolution of issues.
Monitor and analyze trial progress to support deliverables and goals.
Act as Lead CCSL when required, coordinating program and trial activities.
Support and manage the internalized flexible model, collaborating with Clinical Monitoring Leads and CRAs.
Manage the internalized flexible model, partnering with Clinical Monitoring Leads and Site Managers to ensure clear communication with FSPs and effective country-level operations, while supporting fully outsourced teams.
Requirements
Required Skills:
Minimum 8 years of clinical research experience.
Experience managing clinical trial activities, particularly in an outsourced model with CROs.
Strong understanding of cross-functional drug development and scientific knowledge across therapeutic areas.
Familiarity with ICH/GCP guidelines and applicable country regulations.
Strong project management and organizational skills.
Effective knowledge of IT tools for virtual teamwork.
Excellent communication skills, including proficiency in English.
Ability to handle a high volume of tasks and assimilate new knowledge rapidly.
University degree with a scientific background; advanced degree preferred.
Preferred Skills:
Leadership skills and experience in a collaborative decision-making environment.
Proven ability to build and maintain relationships across the organization.
Experience in handling sponsor oversight activities in a flexible service provider model.
Willingness to travel 20% - 25%.
The expected salary range for this position is $127,000 to $169,750 and includes eligibility for a discretionary bonus.
In addition to compensation, Biogen offers a full and highly competitive range of benefits designed to support our employees' and their families physical, financial, emotional, and social well-being; including, but not limited to hea
As a Clinical Country and Site Lead (CCSL), you will play a pivotal role in advancing global clinical development strategies by harnessing key local operational and scientific knowledge. Your strategic focus will be on fostering local partnerships to enhance global customer satisfaction and support the execution of our development pipeline.
This role will provide global teams with in-depth local insights, ensuring that regional opportunities and needs are integrated into operational plans. At the country level, you will direct operational priorities and manage resources effectively, serving as the primary point of contact for investigators, affiliate office staff, CRO staff, and global teams. Your expertise will ensure the successful delivery of local clinical trials while maintaining a focus on quality and patient safety. Additionally, you'll address investigator concerns and collaborate with internal teams to support innovative working methods.
This role collaborates with Clinical Site Engagement and Clinical Monitoring teams (Internalized Flexible Model) to support new ways of working. It partners with Clinical Monitoring Leads, Site Managers, and FSPs to ensure effective coordination among CCSLs, monitoring teams, and study teams at the country level.
This job posting is for an existing vacancy in the organization
Biogen · Toronto, Canada