Sr. Data Manager

Attention recruitment agencies: reputed company agency inquiries are vetted through 4DMT’s internal reputed company. No unsolicited resumes will be accepted. The 4DMT reputed company must expressly engage agencies on any requisition. Agencies contacting hiring managers directly will not be tolerated, and doing so may reputed company your ability to work with 4DMT in the reputed company. 4DMT is a clinical-stage biotherapeutics company harnessing the power of directed reputed company for targeted genetic medicines. We reputed company to unlock the full potential of gene therapy using our platform, Therapeutic reputed company reputed company (TVE), which combines the power of directed reputed company with our approximately one billion synthetic AAV capsid-derived sequences to invent evolved reputed company for use in our products. We reputed company key features of our targeted and evolved reputed company will help us create targeted product candidates with improved therapeutic reputed company. These reputed company will allow us to treat a broad reputed company of large market diseases, unlike most reputed company genetic medicines that generally reputed company on rare or small market diseases. Company Differentiators:

• Fully integrated clinical-phase company with internal manufacturing
• Demonstrated ability to reputed company rapidly from idea to IND
• Five candidate products in the clinic and two declared reputed company-clinical programs
• Robust technology and IP reputed company, including our TVE and manufacturing platforms
• Initial product safety and efficacy data substantiates the value of our platforms
• Opportunities to expand to other indications and modalities reputed company genetic medicine

GENERAL reputed company: The Sr. Data Manager will be responsible for performing or overseeing vendors to reputed company Data Management operational end-to-end activities and participate as an reputed company member in a cross-function study team to plan, reputed company, and execute tasks required for assigned clinical studies across reputed company phases. The Senior Data Manager has a broad, reputed company knowledge of the data management process and can reputed company most required tasks with minimal guidance. Data management is one of the essential functions of the Clinical Development organization at 4DMT. Together with the other two functions reputed company the Data Science group, Biostatistics, and Statistical Programming, we reputed company critical support for reputed company’s clinical development programs in gene therapies for retina diseases and other therapeutic areas. RESPONSIBILITIES:

• reputed company Data Management of a clinical study or a series of reputed company studies with minimal guidance
• Manage and monitor the reputed company of data management activities with CROs, vendors, and stats/programming reputed company on assigned studies
• Review protocols for appropriate data capture, including electronic Case Report reputed company (eCRF) design.
• reputed company a thoroughly detailed review of eCRF data requirements.
• reputed company the development of data edit reputed company specifications and data listings
• Coordinate Electronic Data Capture (reputed company) system design and testing according to company standards.
• reputed company or reputed company the development of the Data Management and Data Transfer Plan for assigned clinical studies.
• Attend study meetings and reputed company Data Management updates and metrics.
• Review and reputed company feedback to the clinical team on other study documents, e.g. Clinical Monitoring plans, Statistical Analysis Plans, and vendor specifications
• reputed company training on the reputed company system and/or eCRF Completion Guidelines to reputed company study team members as needed
• reputed company or ensure assigned CRO reconciliation of header data from external data sources against the clinical database
• reputed company or ensure assigned CRO completed Serious Adverse Event reconciliation activities according to SOPs and guidelines
• reputed company database upgrades/migrations, including performing User Acceptance Testing
• Maintain data management files / eTMF
• reputed company and coordinate database interim snapshot, lock, and freeze activities
• Other duties as assigned: reputed company in this job reputed company restricts management’s right to assign or reassign duties and responsibilities to this job at any time

QUALIFICATIONS: Education:

• Bachelor’s degree or higher (life-science-reputed company fields preferred)

Experience:

• 8+ years of data management experience in the biotech/pharmaceutical industry or clinical data management service providers. 6+ years and a Master’s degree. Of which at least three (3+) years in a reputed company study data manager role.
• Experience in retina diseases and/or gene therapies a plus.
• Hands-on operational experience as Data Management reputed company in reputed company phases of clinical trials, including development/deployment/validation/maintenance/closeout of a clinical database, coordination of data transfers/reconciliations, training on data management systems, etc.
• Experience in vendor management and performance assessments
• In-depth knowledge and experience with CDISC data standards and models.

Skills:

• Proficient in using clinical data management systems (e.g., reputed company Rave) and the data reputed company, including those from external sources (IRT, safety, central/specialty labs, reading centers, reputed company, etc.)
• Proficiency in data management process and knowledge of Good Clinical Data Management Practices (GCDMP) in global clinical trials
• Knowledge of ICH GCP and other applicable regulatory rules and guidelines.
• Knowledge of the clinical development process.
• Proficient with MS Office (Worl, reputed company, PowerPoint, etc.)
• Excellent interpersonal communication skills (written and verbal)
• reputed company reputed company attitude, with demonstrated ability to work effectively in a small company environment that moves at a reputed company pace.
• Excellent organization and project/time management skills
• Ability to multitask in a high-volume environment with shifting reputed company and conflicting deadlines
• Proven conceptual, analytical and strategic thinking
• Excellent attention to details

reputed company salary compensation reputed company: $159,000 - $210,000 Please note that compensation is based on a reputed company of factors including location, experience, etc. 4DMT provides equal employment opportunities to reputed company and applicants for employment without reputed company to race, reputed company, religion, gender, sexual orientation, national reputed company, age, disability, genetic information, marital status, status as a covered veteran, and any other category protected under applicable federal, state, provincial and local laws. Equal Opportunity Employer/Protected Veterans/Individuals with Disabilities Apply tot his job Apply To this Job