Senior Clinical Trial Transparency Specialist

🔥 0 minutes ago

🇺🇸 United States – Remote

💵 $116k - $155k / year

⏰ Full Time

🟠 Senior

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Biogen

WebsiteLinkedInAll Job Openings

5001 - 10000 employees

🏥 Healthcare

🏭 Manufacturing

🧬 Biotechnology

Healthcare • Manufacturing • Biotechnology

Biogen is a biotechnology company dedicated to discovering, developing, and delivering innovative therapies for people living with serious neurological diseases, including Alzheimer's disease, multiple sclerosis, and spinal muscular atrophy. With a strong emphasis on research and development, Biogen continues to advance the science of neurology through clinical trials and strategic partnerships, while also striving for access and health equity in healthcare.

📋 Description

• Lead disclosure planning and delivery for assigned clinical studies • Coordinate protocol registration, record maintenance, and results disclosure activities • Serve as the primary Clinical Trial Transparency contact for assigned study teams • Partner with vendors to deliver accurate, timely, high-quality registry disclosures • Monitor vendor workload, performance metrics, cycle times, and issue logs • Escalate disclosure risks, dependencies, and quality concerns as appropriate • Support planning, coordination, and quality review of plain language summaries • Improve Clinical Trial Transparency processes, work instructions, SOPs, and training • Provide user feedback and support testing for Clinical Trial Transparency technology solutions • Represent the function on cross-functional initiatives and continuous-improvement projects • Work closely with Clinical Development, Regulatory Affairs, Medical Writing, Data Management, and external service providers

🎯 Requirements

• Bachelor’s degree in a science related field • 4+ years of relevant pharmaceutical-industry experience or equivalent • 2+ years of experience with global clinical trial transparency knowledge and disclosure requirements • Experience with clinical trial registration and results disclosure activities • Understanding of clinical study and program communication-planning dependencies • Process mapping and continuous improvement experience • Vendor-management experience in an outsourced operating model • Ability to monitor deliverables, quality, timelines, metrics, and issues • Familiarity with Clinical Trial Transparency technology, systems, and tools • Knowledge of plain language summaries and patient-centered trial communication • Strong cross-functional communication and stakeholder-management skills • Preferred: Experience supporting or leading SOP, work-instruction, or training updates • Preferred: Familiarity with data sharing, patient engagement, health equity, or digital engagement

🏖️ Benefits

• Short-term and long-term incentives, including cash bonus and equity incentive opportunities • Medical, Dental, Vision, & Life insurances • Fitness & Wellness programs including a fitness reimbursement • Short- and Long-Term Disability insurance • A minimum of 15 days of paid vacation • End-of-year shutdown time off (Dec 26-Dec 31) • Up to 12 company paid holidays • 3 paid days off for Personal Significance • 80 hours of sick time per calendar year • Paid Maternity and Parental Leave benefit • 401(k) program participation with company matched contributions • Employee stock purchase plan • Tuition reimbursement of up to $10,000 per calendar year • Employee Resource Groups participation