Biogen
Manager, Informed Consent Management Oversight Lead
Remote, USA
Sponsorship not specified$122k-$163kDetected 26 days ago
GCPProject ManagementProcess ImprovementClinical TrialsHealth LiteracyFDA RegulatoryPharmacovigilancePlain LanguageOrganizational Skills
About the role
- 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).
- You see the value in maintaining high-quality, easily understandable materials that enable potential trial participants to make informed decisions.
- As a mid-sized biotechnology company, we provide the stability and resources of a well-established business while fostering an environment where individual contributions make a significant impact.
Responsibilities
- 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.
- 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.
- 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.
- 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
- Experience in Clinical Operations, particularly in Study Delivery/Start Up, and a good understanding of GCP, relevant ICH standards, and FDA/EMA guidelines.
- Strong project management and organizational skills, including the ability to prioritize needs and handle a high volume of tasks within a given timeframe.
- 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.
Nice to have
- Preferred Skills
Compensation
- Tuition reimbursement of up to $10,000 per calendar year
Benefits
- Medical, Dental, Vision, & Life insurances
- Fitness & Wellness programs including a fitness reimbursement
- Paid Maternity and Parental Leave benefit
- 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)
- Employee stock purchase plan
- 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.
Company info
- Up to 12 company paid holidays + 3 paid days off for Personal Significance
- 401(k) program participation with company matched contributions
- We are a global team with a commitment to excellence, and a pioneering spirit.
This listing is sourced directly from Biogen's careers page and normalized into a canonical job model.