Clinical Country and Site Lead, Canada
About The Position
In this strategically focused role of Clinical Country Site Lead, you will drive global clinical development strategies by providing essential local operational and scientific expertise. As part of a regionally aligned team, your contributions will be pivotal in enhancing global customer satisfaction and supporting the delivery and execution of Biogen's development pipeline. You will manage the integration of local opportunities into global strategies and ensure operational plans reflect country-specific needs. Serving as the primary contact for Investigators, affiliate office staff, CRO staff, and global teams, your role is crucial in delivering local clinical trials with a focus on quality, patient safety, and effective oversight. The Clinical Country Site Lead is a key player in ensuring that investigator concerns are promptly addressed, safeguarding data integrity and patient safety, while contributing to the overall success of Biogen’s clinical research endeavors. This job posting is for an existing vacancy in the organization.
Requirements
- University degree with a science background or equivalent education and experience; advanced degree preferred.
- Minimum 8 years of clinical research experience, with an emphasis on managing clinical trial activities and sponsor oversight.
- Strong communication skills, including proficiency in English in non-English speaking countries.
- Understanding of the cross-functional drug development process and scientific knowledge across key therapeutic areas.
- Knowledge of ICH/GCP, country regulations, and clinical trial monitoring in an outsourced model.
- Strong organizational and project management skills.
- Effective working knowledge of IT tools for virtual teamwork.
- Excellent knowledge of clinical operational activities across local geography.
- Ability to handle high volumes of tasks with varying complexity and priorities.
- Proficiency in working across multiple digital platforms and early adoption of new systems/applications.
Nice To Haves
- Experience in managing sponsor oversight activities in an outsourced/FSP model with CROs/vendors.
- Proven ability to build relationships throughout and across the organization while operating remotely.
- Willingness to travel 20% - 25%.
Responsibilities
- Maintain up-to-date local knowledge of therapeutic areas researched by Biogen, standards of care, and clinical trial requirements.
- Engage in operational and scientific discussions as the local QSDO representative to offer country-level insights on therapeutic areas related to studies and programs.
- Support and drive global operational strategy by providing study information.
- Highlight country-level capabilities and needs through investigator and site knowledge.
- Manage relationships with investigators and sites to foster collaboration and satisfaction.
- Position Biogen as the preferred partner for clinical trials through strong investigator partnerships.
- Lead local activities in the country and site selection process, ensuring stakeholder input.
- Act as the primary country-level contact for strategic development and execution of sponsor oversight of CRO activities.
- Oversee compliance with ICH/GCP, local regulations, and sponsor requirements through Sponsor Oversight Visits and audit support.
- Serve as the primary contact for all QSDO clinical studies, ensuring issue resolution and timely information flow.
- Monitor and analyze trial and country progress to support QSDO deliverables and country goals.
- Address local trial challenges and ensure effective communication and alignment with global teams.
- Act as Lead CCSL for study or program leadership as required, coordinating various activities.
- Train aCCSLs/CCSLs on therapeutic areas, program communications, and CSO activities.
- Perform company business in compliance with regulations, policies, and procedures.
Benefits
- Discretionary bonus
- Short term and long-term incentives, including cash bonus and equity incentive opportunities
- Health care
- Retirement
- Paid time off
- Fully paid sabbatical after six years of service
- Employee Stock Purchase Plan participation
- Education assistance
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What This Job Offers
Job Type
Full-time
Career Level
Manager
