Clinical Data Manager
MeiraGTx is a clinical-stage gene therapy company focused on developing potentially curative treatments for patients living with serious diseases. We currently have six programs in clinical development including three ocular indications, a salivary gland condition, and a Parkinson’s disease program. Our initial focus on diseases of the eye, salivary gland and central nervous system is based on the significant unmet medical need coupled with the high potential gene therapy has to provide meaningful clinical benefit in these areas. With headquarters in New York and London, our global footprint provides us the opportunity to partner with leading institutions around the world, allowing us to deepen our understanding of diseases and their progression.
Our team was built with deep expertise in gene therapy development, allowing us to efficiently advance our programs from preclinical to clinical development. Our core capabilities in viral vector design and optimization and gene therapy manufacturing give us a differentiated approach to developing gene therapies. Additionally, we are developing proprietary technology to potentially enable innovative gene therapy treatments whose expression can be turned on and off with an easily administered small molecule. We believe temporal control of gene therapy products has the potential to transform the gene therapy landscape.
Our state-of-the-art manufacturing facility, completed in early 2018, was designed to meet global regulatory requirements, including the current good manufacturing practices (cGMP) required by the Medicines and Healthcare products Regulatory Agency (MHRA) in the UK and the U.S. Food and Drug Administration (FDA). The 29,000-square foot facility has the flexibility and capacity to produce sufficient product for all our clinical trials and will scale to commercial capacity.
Purpose of Job
Manage and execute Data Management (DM) activities within the framework of clinical trials to ensure the completeness, accuracy and consistency of the data meet the standards of quality for analysis and reporting to regulatory bodies in compliance with local and global regulations
- Protocol development: Contribute to protocol design (e.g., what and when data are to be collected, feasibility of data collection), protocol and amendment review
- Be an active member of the clinical study team
- Trial start-up: set up of data collection tools by the CRO: review (e)CRF and ancillary documents related to data collection (e.g., data transfer agreements with other vendors, PRO’s, diaries…)
- Trial start-up: set up of data handling tools by the CRO: Check data validation measures for completeness and accuracy, review data safety measures (plan, medical review, SAE reconciliation plan…), contribute to definition of protocol deviations.
- Trial conduct: oversee CRO’s data collection/review metrics, evaluate SDTM definitions and mapping, perform data content and structure QC.
- Trial close-out: perform final QC on CRO deliverables, ensure completeness of data package before database lock and submission package after lock, finalize all required documentation and oversee transfer and archiving of the data management component of the Trial Master File.
- Follow up on trial timelines from trial start through close out and escalate issues, if required
- Lead/participate in initiatives on process improvements
- Participate in regulatory agency and internal audits, when appropriate
Key Performance Indicators
- Timely setup of qualitative data collection tools at the CRO, ensuring contemporaneous data collection on site
- Timely delivery of scientifically sound clinical data, fit for statistical analysis, avoiding database reopenings
Key Job Competencies
- Knowledge of ICH-GCP, EU and US regulatory requirements
- CDISC standards knowledge: SDTM and define.xml
- Accuracy/Precision: data review needs to be meticulous
- High quality standards: an eye for detail
- Strong problem solving and analytical skills
- Strong communication and interpersonal skills
- Able to work independently as well as in a team environment
- MS Office: proficient level
- Fluent in English, written and spoken
- Financial authority: none
- Direct reports: none
- Expected educational qualifications: BS or MSc in relevant field of life sciences or equivalent by experience
- Expected experience: 2-7 years of experience in DM, experience with at least 1 EDC system, knowledge of SDTM and define.xml is required
*UK or Belgium based