Manager, Informed Consent Management Oversight Lead

🔥 0 minutes ago

🏄 California – Remote

🏄 California – Remote

💵 $122k - $163k / year

⏰ Full Time

🟠 Senior

👔 Manager

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Biogen

WebsiteLinkedInAll Job Openings

5001 - 10000 employees

🧬 Biotechnology

⚕️ Healthcare Insurance

💊 Pharmaceuticals

Biotechnology • Healthcare Insurance • Pharmaceuticals

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

• Monitor the ICF Mailbox to identify, manage, and provide resolution or triage incoming requests; • Liaison with key ICF stakeholders to support resolution of complex ICF Issues. • As Subject Matter Expert, manage and provide resolution when IRBs/ECs have requests to modify a Biogen study ICF. • Assess requests to determine appropriate resolution and/or involvement of other stakeholders, e.g., legal counsel, data privacy officer, and pharmacovigilance scientists, for timely resolution. • Provide SME support during SSU at the study planning stage, as well as throughout the lifecycle of a clinical study through oversight of Biogen’s CRO Partners to ensure compliant and timely consent of subjects. • Analyze project/study team requirements, activity timelines and work scope to identify resource needs. • Bring ICM perspective to protocol authoring and write the Global Master ICF(s) when needed, depending on operating model. • Support monitoring of controlled process documents for compliance with Biogen policies and changes in laws and regulations. • Support monitoring of the informed consent process to ensure timeliness, accuracy, and compliance with regulatory obligations and internal KPIs. • Produce and analyze KPI metrics on compliance, performance, and quality. • Evaluate trends and identify areas of improvement. • Support cross-functional process improvement initiatives and ensure that the needs of the ICM process are considered. • Support the maintenance of Standard Operating Procedures and Work Instructions for the IC process, consistent with Quality Documentation requirements and GCO standards.

🎯 Requirements

• Bachelor’s Degree and/or combination of education, training, and experience that provides the individual with the required knowledge, skills and abilities for the position. • 5+ years’ experience in the biotechnology/pharmaceutical industry or relevant healthcare experience. • Experience in Clinical Operations, particularly in Study Delivery/Start Up, and a good understanding of GCP, relevant ICH standards, and FDA/EMA guidelines. • Experience in authoring/reviewing ICF documents and/or other patient-facing material, health literacy plain language writing experience (translate complex clinical, medical, and scientific information in support of participant understanding). • Strong project management and organizational skills, including the ability to prioritize needs and handle a high volume of tasks within a given timeframe.

🏖️ Benefits

• 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 and an additional 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