Senior Manager, Data Management

GENERAL SUMMARY:

The Senior Manager Data Management leads execution of endtoend clinical data management activities for assigned studies and provides operational oversight to internal staff and external vendors. This role serves as a key member of crossfunctional study teams contributing to planning execution and delivery of highquality clinical trial data across all phases. The Senior Manager possesses robust working knowledge of clinical data management processes and independently executes most tasks while also providing guidance to other Data Managers and vendor partners.

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:

• Manage endtoend Data Management activities for one or more clinical studies with moderate guidance from line manager.
• Oversee daily studylevel data management operations ensuring compliance to timelines quality standards and SOPs.
• Support vendor oversight activities including reviewing timelines deliverables and quality metrics.
• Contribute to risk identification and mitigation strategies for datarelated issues.
• Review study protocols to ensure appropriate data capture elements and eCRF design.
• Support the development of eCRF specifications and contribute to review of data requirements.
• Assist in coordinating EDC system design testing and UAT ensuring adherence to company standards.
• Contribute and/or author Data Management Plans Data Transfer Plans and other studyrelated documents
• Support review of clinical monitoring plans SAPs and vendor specifications.
• Monitor data quality and cleaning activities including management of data listings and reconciliation efforts.
• Partner with CROs and external vendors to ensure timely and highquality data deliverables.
• Participate in study team meetings providing updates on Data Management metrics and timelines.
• Escalate issues appropriately to line manager data management leadership or other functional leads.
• Oversee reconciliation activities (e.g. header data SAE reconciliation) performed by CROs.
• Support database upgrades and migrations including contribution to UAT.
• Participate in database snapshot lock and freeze activities.
• Provide daytoday guidance and mentorship to Data Managers.
• Deliver training to internal and external team members on EDC systems or eCRF completion guidelines as needed.
• Maintain Data Management documentation and eTMF files.
• Other duties 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:

• 7 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 with Phase 1-3 clinical trials required: retina diseases and/or gene therapies experience a plus.
• Demonstrated experience in vendor oversight and crossfunctional team leadership.
• 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.)
• Strong communication and interpersonal skills (written and verbal)
• Collaborative mindset with ability to work effectively.
• High attention to detail with excellent organizational and timemanagement capabilities.
• Ability to manage multiple projects in a fast-paced environment
• Proven conceptual analytical and strategic thinking
• Excellent attention to details

Travel: 0-10% based on study needs.

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:$178000 - 208000

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.