The Manager, Informed Consent Management Oversight Lead is part of the Informed Consent Management (ICM) team within Quantitative Sciences & Development Operations (QSDO) and will support timely delivery of Biogen's clinical trials during Study Start Up and Maintenance. This team defines and oversees the process to ensure that ICFs are of high quality and delivered on time to meet key study milestones, such as submission to regulatory authorities and IRBs/Ethics Committees (ECs). As a Manager in Informed Consent Management (ICM), you will lead and support cross-functional teams that develop/implement processes, support key projects and initiatives, and ensure compliance with internal processes and external requirements. You will support all studies within the Biogen portfolio and will work across all global regions. As ICM is an integral part of Study Start-up (SSU), you will provide strategic project and study level support to meet clinical study milestones.
What You'll Do- 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.
Who You AreYou enjoy coordinating various activities and bringing information/data together to tell a story and support decision making. You see the value in maintaining high-quality, easily understandable materials that enable potential trial participants to make informed decisions.
Required Skills- 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.
Preferred Skills- Experience with eConsent and supporting technologies, such as use of videos and avatars, in the consent process.
- Knowledge of the informed consent process in clinical trials, including creation and adaptation of ICFs to local IRB requirements, liaise and negotiate ICFs between study sites, sponsors, CROs and IRB/ECs.
- Proficiency in Veeva to support document management and workflow coordination.
Job Level: Management
Additional InformationThe base compensation range for this role is: $122,000.00-$163,000.00
Base salary offered is determined through an analytical approach utilizing a combination of factors including, but not limited to, relevant skills & experience, job location, and internal equity.
Regular employees are eligible to receive both short term and long-term incentives, including cash bonus and equity incentive opportunities, designed to reward recent achievements and recognize your future potential based on individual, business unit and company performance.
In addition to compensation, Biogen offers a full and highly competitive range of benefits designed to support our employees' and their families physical, financial, emotional, and social well-being; including, but not limited to:
- 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
