Director, Clinical Data Management
- Employer
- Inozyme Pharma
- Location
- Boston, MA
- Start date
- Feb 3, 2025
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- Discipline
- Clinical, Clinical Data, Clinical Research
- Required Education
- Bachelors Degree
- Position Type
- Full time
- Hotbed
- Genetown
Job Details
Position Overview:
The Director of Clinical Data Management will be responsible for the oversight of CDM activities outsourced to CROs, from study startup through study closeout. The individual would also be responsible for the development and implementation of clinical data management strategies and processes to enable the delivery of data capture, review and reporting systems that facilitate timely availability of actionable data to enable fast and efficient drug development. May have line management responsibilities.
Reporting Relationship: This person will report to the VP, Biometrics
About Inozyme Pharma:
Inozyme Pharma is a pioneering clinical-stage biopharmaceutical company dedicated to developing innovative therapeutics for rare diseases that affect bone health and blood vessel function. We are experts in the PPi-Adenosine Pathway, where the ENPP1 enzyme generates inorganic pyrophosphate (PPi), which regulates mineralization, and adenosine, which controls intimal proliferation (the overgrowth of smooth muscle cells inside blood vessels). Disruptions in this pathway impact the levels of these molecules, leading to severe musculoskeletal, cardiovascular, and neurological conditions, including ENPP1 Deficiency, ABCC6 Deficiency, calciphylaxis, and ossification of the posterior longitudinal ligament (OPLL).
Our lead candidate, INZ-701, is an ENPP1 Fc fusion protein enzyme replacement therapy (ERT) designed to increase PPi and adenosine, enabling the potential treatment of multiple diseases caused by deficiencies in these molecules. It is currently in clinical development for the treatment of ENPP1 Deficiency, ABCC6 Deficiency, and calciphylaxis. By targeting the PPi-Adenosine Pathway, INZ-701 aims to correct pathological mineralization and intimal proliferation, addressing the significant morbidity and mortality in these devastating diseases.
Essential Duties and Responsibilities:
- Provide Clinical Data Management oversight of CRO and other external data vendors and ensure adherence to agreed project timelines and budgets.
- Provide leadership and expertise in data management ensuring data quality and regulatory compliance/
- Manage vendor relationships or partnerships from a Clinical Data Management perspective.
- Ensure the delivery of quality data by partnering with CROs and external vendors to develop and execute efficient quality data processes.
- Developing strategies for and implementing ongoing improvements within Clinical Data Management to ensure the quality and integrity of the clinical data from Inozyme Clinical trials.
- Perform hands-on clinical data management study activities, including the development of case report forms (CRF).
- Determines the appropriate and effective use of data management information and system tools for data and report retrieval, data listing review, error detection and production of standard displays to ensure quality data.
- Identifies opportunities, and implements solutions to globalize and standardize methods, processes, procedures, systems and templates in accordance with CDISC/SDTM requirements and industry best practices.
- Develop, review and implement Clinical Data Management processes, policies and SOPs.
- Participate in technology provider and Clinical vendor qualifications and audits.
- Support study-level/program audit and inspection readiness activities as needed.
- Train and mentor members of the clinical trial team form other functions on processes, projects, systems and programs.
- Lead data management support of submission activities.
- Maintains proficiency in Data Management systems and processes through regular training and/or attendance at professional meetings/conferences.
- Line-Management responsibilities, if required.
Educational Qualifications:
- Bachelor’s degree, preferably in a scientific or engineering discipline such as Physical & Life Sciences, Statistics, Mathematics, Computer Science, IT, Biology.
- 10+ years working in clinical data management, with experience building data management functions and developing initiatives designed to promote efficiency and productivity.
- Extensive knowledge of clinical data management outsourcing models including functional-service providers and full-service CROs
- Experience leading and overseeing teams to ensure the timely provision of DM deliverables.
- Advanced hands-on knowledge of data management processes and systems.
- Knowledge of regulatory requirements (e.g. ICH, GCP, HIPAA, FDA requirements)
- Strong project management skills, and ability to effectively lead and collaborate with various business functions.
- Demonstrated ability of working on multiple projects simultaneously, independently managing competing priorities, and define tracking tools to manage projects.
- Excellent written and verbal communication skills, able to communicate effectively with senior management as well as with peers.
- CDASH, CDISC & SDTM experience.
- Demonstrated ability to influence without authority.
- Demonstrate initiative, sound judgment and flexibility.
- Solid understanding of clinical drug development processes.
- Experience with PROs and eCOA data
Additional Qualifications:
- Experience with data visualization, analytics and reporting tools
- Experience programming in R, SAS, Python or other languages
Company
We are one energized Team, developing unique pathways to realize possibilities for patients without treatment options.
Rare Patients.
Rare Solutions.
- Website
- http://www.inozyme.com/
- Location
-
321 Summer St
Suite #400
Boston
Massachusetts
02210
United States
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