At Neurogene, we are working to provide medicines to improve the lives of neurologically impaired children and their families. We envision a world in which all families have access to genetic medicines, even if the disorder is exceedingly rare. For children, our goal is to enable them to have a healthier future. For families, we want to make their lives better by easing the challenges of caring for someone with a devastating neurological disorder. As an employee of Neurogene, you will be part of a culture helping to make this dream a reality, collaborating with people in a start-up environment, whose mission is to improve the lives of the patients we serve and make the world a better place.
Neurogene is seeking a Director, Senior Clinical Data Management to execute data deliverables for all phases of clinical trials as part of the clinical development study team. This role will proactively collaborate within cross-functional Neurogene study teams, Contract Research Organizations and other data vendors, driving end-to-end data quality and integrity from source through to submission.
Accountabilities and Responsibilities
• Lead Clinical Data Management (DM) for assigned complex studies from study start-up to the database lock.
• Function as internal Study Data Manager, overseeing all data management activities performed by CROs; ensuring major DM deliverables and milestones are met.
• Oversee clinical database built by the vendors, facilitate database design according to the protocol, perform and facilitate clinical database User Acceptance Testing.
• Oversee external data transfers, review, cleaning and medical coding by vendors by tracking study metrics and targeted data review.
• Participate in the Clinical DM vendor selection and oversight at the study level.
• Ensure compliance with the Clinical DM SOPs at the study level.
• Create specifications for internal study team data review plans. Lead internal study team in data review; perform data review for quality issues and general data trends; generate queries as necessary.
• Represent Clinical DM at study team meetings, provide agenda items and follow-up on action items through resolution. Serves as a Study DM liaison with cross-functional team members and external vendors to ensure completion of all timelines and study-related tasks.
• Assist Quality Assurance and the Clinical Study Teams as needed with inspection readiness activities.
• Review and manage key Clinical DM study documents, such as DM plans, guidelines for CRF completion, data review, SAE reconciliation, Vendor Oversight, TMF plans, and data audits. Ensure Clinical DM Study Documentation is up to date and filed as appropriate Minimum Requirements/ Qualifications.
-Bachelors degree in data science, life science, computer science, pharmacy or nursing
-Minimum of 8 years of relevant Clinical DM experience.
-Experience pediatrics, neurology, rare diseases and/or gene therapy would be ideal.
Skills, Knowledge & Attributes
-Knowledge of current FDA Regulations, GCP and ICH guidelines in clinical trials.
-Proficient written and verbal communication skills.
-Ability to collaborate effectively with the study team and cross-functional team members.
-Ability to work independently, as well as within a cross-functional team environment.
-Strong computer skills, including Medidata Rave and other EDC systems.
-Desire and ability to work in a fast-paced, dynamic start-up and scaling environment.
-Passionate, collaborative, creative, willing to take prudent risks, and motivated by the creation of a company focused on transformative treatments for patients and their families.
-Strong attention to detail.
-Demonstrated organizational and collaboration skills.
-Ability to deliver professional and quality work products, while working on multiple projects.