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Associate Clinical Country Lead

Biogen
Riyadh, KSA
Full Time
Mid
1 months ago
Clinical ResearchICH GCPRegulatory ComplianceProject ManagementStakeholder ManagementCRO Oversight
Free

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Clinical ResearchICH GCPRegulatory Compliance
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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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