Biogen is a global biotechnology company that discovers, develops, manufactures, and markets life-saving treatments for people with neurological, autoimmune, an
Manager, Informed Consent Management Oversight Lead
Location
California
Posted
2 days ago
Salary
$122K - $163K / year
Seniority
Senior
Job Description
Manager, Informed Consent Management Oversight Lead
Biogen
• 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.
Job 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
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