Associate Director, Data Management

GENERAL SUMMARY:

The AD Data Management will be responsible for performing or overseeing vendors to perform Data Management operational end-to-end activities and participate as an active member in a cross-function study team to plan lead and execute tasks required for assigned clinical studies across all phases. The AD Data Management has a broad fundamental knowledge of the data management process and can perform 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 within the Data Science group Biostatistics and Statistical Programming we provide critical support for the companys clinical development programs in gene therapies for retina diseases and other therapeutic areas.

MAJOR DUTIES & RESPONSIBILITIES:

• Lead Data Management of a clinical study or a series of related studies with minimal guidance
• Manage and monitor the progress of data management activities with CROs vendors and stats/programming groups on assigned studies
• Review protocols for appropriate data capture including electronic Case Report Form (eCRF) design.
• Perform a thoroughly detailed review of eCRF data requirements.
• Lead the development of data edit check specifications and data listings
• Coordinate Electronic Data Capture (EDC) system design and testing according to company standards.
• Develop or lead the development of the Data Management and Data Transfer Plan for assigned clinical studies.
• Attend study meetings and provide Data Management updates and metrics.
• Review and provide feedback to the clinical team on other study documents e.g. Clinical Monitoring plans Statistical Analysis Plans and vendor specifications
• Provide training on the EDC system and/or eCRF Completion Guidelines to internal and external study team members as needed
• Perform or ensure assigned CRO reconciliation of header data from external data sources against the clinical database
• Perform or ensure assigned CRO completed Serious Adverse Event reconciliation activities according to SOPs and guidelines
• Lead database upgrades/migrations including performing User Acceptance Testing
• Maintain data management files / eTMF
• Perform and coordinate database interim snapshot lock and freeze activities
• Other duties as assigned: nothing in this job description restricts managements right to assign or reassign duties and responsibilities to this job at any time

QUALIFICATIONS:

Education:

• B.A./B.S. degree or higher (life-science-related fields preferred); or equivalent experience.

Experience:

• 9 years of data management experience in the biotech/pharmaceutical industry or clinical data management service providers of which at least three (3) years in a lead study data manager role.
• Experience in retina diseases and/or gene therapies a plus.
• Hands-on operational experience as Data Management Lead in all 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.

Other Qualifications/Skills:

• Proficient in using clinical data management systems (e.g. Medidata Rave) and the data flow including those from external sources (IRT safety central/specialty labs reading centers PROs 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 Excel PowerPoint etc.)
• Excellent interpersonal communication skills (written and verbal)
• Innate collaborative attitude with demonstrated ability to work effectively in a small company environment that moves at a tremendous pace.
• Excellent organization and project/time management skills
• Ability to multitask in a high-volume environment with shifting priority and conflicting deadlines
• Proven conceptual analytical and strategic thinking
• Excellent attention to details

Travel: 5%

Physical Requirements and Working Conditions:

• Physical Activity - Repetitive motions: Making substantial movements (motions) of the wrists hands and/or fingers. Fingering: Picking pinching typing or otherwise working primarily with fingers rather than with whole hand or arm as in handling. Talking: Expressing or exchanging ideas by means of the spoken word.
• Physical Requirements - Sedentary work: Exerting up to 10 pounds of force occasionally and/or a negligible amount of force frequently or constantly to lift carry push pull or otherwise move objects including the human body. Sedentary work involves sitting most of the time. Jobs are sedentary if walking and standing are required only occasionally and all other sedentary criteria are met.
• Working Conditions - The worker is not substantially exposed to adverse environmental conditions (as in typical office or administrative work).

Base salary compensation range: $170000/yr - $223000/yr

Please note the base salary compensation range and actual salary offered to the final candidate depends on various factors: candidates geographical location relevant work experience skills and years of experience.