Associate Clinical Country Lead
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Key skills for this role
About the Role
Biogen seeks an Associate Clinical Country & Site Lead to provide local operational and scientific knowledge for clinical trials in Saudi Arabia. You will build relationships with investigators, oversee CRO activities, and ensure quality and patient safety.
Key Skills for This Role
Responsibilities
- Maintain up to date local knowledge of Biogen’s therapeutic areas and clinical trial requirements
- Build and maintain strong relationships with investigators and sites
- Support country and site selection activities by gathering local insights
- Act as primary country level contact for sponsor oversight activities including SOVs, audits, and inspections
- Perform co monitoring activities during Sponsor Oversight Visits
- Lead interactions with investigators, affiliate teams, CRO staff, and global stakeholders
- Monitor and assess overall trial and country performance
Requirements
- University degree in science or equivalent combination of education and experience
- Minimum 5 years clinical research experience
- Understanding of ICH/GCP and applicable country regulations
- Strong organizational and project management skills
- Excellent interpersonal and communication skills
- English language proficiency
Full Job Posting
About This Role
- As an Associate Clinical Country & Site Lead, you will be an external facing, country aligned clinical operations position focused on providing key local operational and scientific knowledge to support country level clinical development strategy.
- You will work closely with the Director, Clinical Country & Site Lead, as well as the Clinical Country & Site Lead or Senior Clinical Country & Site Lead in country.
- You will serve as a single point of contact for investigators, affiliate office staff, CRO staff, and QSDO/global teams.
What You'll Do
- Maintain up to date local knowledge of Biogen’s therapeutic areas, standards of care, clinical trial requirements, and the needs of local investigators and research sites.
- Build and maintain strong relationships with investigators and sites, helping position Biogen as a partner of choice for clinical research.
- Support country and site selection activities by gathering local insights and feedback from investigators and other key stakeholders.
- Act as the primary country level QSDO/Biogen contact for sponsor oversight activities, including Sponsor Oversight Visits (SOVs), audits, inspections, and CRO oversight.
- Perform co monitoring activities during Sponsor Oversight Visits, ensuring trial records, informed consent documentation, and source documents are maintained in accordance with protocol, ICH GCP, SOPs, and local regulations.
- Lead interactions with investigators, affiliate teams, CRO staff, and global stakeholders to facilitate information flow and timely issue resolution across clinical studies.
- Monitor and assess overall trial and country performance to support QSDO objectives and country level goals.
- Contribute to local projects and broader Clinical Study Operations activities as a representative of the country.
Required Skills
- University degree or the equivalent combination of education with a science background and experience required.
- Minimum 5 years clinical research experience. Experience managing clinical trial activities desirable, especially sponsor oversight activities in an outsourced /FSP model with CROs/vendors.
- Understanding of cross functional drug development process and high scientific/clinical knowledge across key therapeutic areas.
- Understanding of ICH/GCP, applicable country regulations and clinical trial monitoring in an outsourced model.
- Strong organizational skills, especially project management skills, with an ability to set clear goals, align priorities and execute on multiple tasks/activities.
- Effective working knowledge of relevant IT tools to promote virtual team working.
- Excellent knowledge of clinical operational activities/challenges across local geography.
- Ideal candidate will be customer focused, with excellent interpersonal skills, cultural awareness, high emotional intelligence and a collaborative decision making approach.
- Proven ability to handle a high volume of tasks of varying complexity within a given timeframe.
- Strong communication skills, including English language skill in countries where English is not the primary language.
Why Biogen?
- We are a global team with a commitment to excellence, and a pioneering spirit.
- As a mid sized biotechnology company, we provide the stability and resources of a well established business while fostering an environment where individual contributions make a significant impact.
- At Biogen, we are committed to building on our culture of inclusion and belonging that reflects the communities where we operate and the patients we serve.
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