Manager, Informed Consent Management Oversight Lead

This is a fully remote position, open to applicants in California.

📋 Description

• Oversee the ICF Mailbox to identify, manage, and resolve incoming requests or triage as necessary;

• Act as a liaison with key ICF stakeholders to facilitate the resolution of intricate ICF issues.

• Serve as the Subject Matter Expert, managing and resolving requests from IRBs/ECs to modify a Biogen study ICF.

• Evaluate requests to determine the appropriate resolution and/or the need for involvement from other stakeholders, such as legal counsel, data privacy officers, and pharmacovigilance scientists, ensuring timely resolutions.

• Provide SME support during the Site Start-Up (SSU) phase at the planning stage and throughout the clinical study lifecycle by overseeing Biogen’s CRO Partners to ensure compliant and timely consent from subjects.

• Analyze project/study team requirements, activity timelines, and work scope to determine resource needs.

• Contribute ICM insights during protocol authoring and draft the Global Master ICF(s) as necessary, depending on the operating model.

• Assist in monitoring controlled process documents for adherence to Biogen policies and updates in laws and regulations.

• Monitor the informed consent process to guarantee timeliness, accuracy, and compliance with regulatory obligations and internal KPIs.

• Generate and analyze KPI metrics related to compliance, performance, and quality.

• Assess trends and identify opportunities for improvement.

• Support cross-functional process enhancement initiatives while ensuring the needs of the ICM process are taken into account.

• Aid in the maintenance of Standard Operating Procedures and Work Instructions for the IC process, aligned with Quality Documentation requirements and GCO standards.

⛳️ Requirements

• Bachelor’s Degree and/or a combination of education, training, and experience that equips the individual with the necessary knowledge, skills, and abilities for the role.

• 5+ years of experience in the biotechnology/pharmaceutical industry or relevant healthcare experience.

• Experience in Clinical Operations, especially in Study Delivery/Start Up, with a solid understanding of GCP, relevant ICH standards, and FDA/EMA guidelines.

• Proficient in authoring/reviewing ICF documents and/or other patient-facing materials, with experience in health literacy and plain language writing to simplify complex clinical, medical, and scientific information for participant understanding.

• Strong project management and organizational abilities, including the capacity to prioritize needs and manage a high volume of tasks within specified timeframes.

🏝️ 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