Trial Master File Administrative Support
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
To undertake a wide variety of Clinical Trial (80%) and departmental administrative (20%) tasks to support the Clinical Operations Director and the Clinical Operations Team. Ensure that MeiraGTx Clinical Operations run smoothly and assist in supporting the successful delivery of Clinical Trial programs and partnerships.
- For studies allocated, with the Trial Master File Manager, set up and maintenance of the Trial Master Files (TMF) or electronic filing systems/ set up of the Investigator Site File (ISF)
- For studies allocated, with the Trial Master File Manager, print-off, QC, track and file documents.
- Co-ordinating archiving of study documentation
- Create & maintain study contact lists for team/sites/3rd parties/set up mail merges.
- Sending out Study Correspondence to all participating sites on an ongoing basis.
- Maintain understanding of Good Clinical Practice
- Provide administrative support for the Clinical Operations team
- Support the team with the preparation of documentation and presentations for meetings and project updates.
- Support the team with booking flights and hotels and raising POs to authorise expenditure.
- Organise and arrange internal and external departmental meetings.
- Support other areas of the business when required.
- Setting up of finance systems accurately, processing invoices & tracking payments for the trial for investigator payments
Key Performance Indicators
- Ensuring the Trial Master Files are appropriately maintained.
- Ensuring tracking systems for trial related paperwork remain up to date.
- Quality Checking all documents prior to filing.
- Effective department administration and support for the Clinical Operations team
- Implement effective systems and processes to improve the efficiency of the department.
Key Job Competencies
- Problem Solving – Identifies and resolves problems in a timely manner; gathers and analyzes information skillfully; develops alternative solutions and works well in group problem solving situations.
- Fast-Paced – able to operate effectively in a fast-paced environment, manages multiple priorities, whilst providing accuracy of information and adding value.
- Change Management – Develops workable implementation plans; communicates changes effectively; builds commitment and overcomes resistance; prepares and supports those affected by change; monitors transition and evaluates results.
- Leadership – exhibits confidence in self and others; inspires and motivates others to perform well; effectively influences actions and opinions of others; accepts feedback from others; gives appropriate recognition to others.
- Cost Consciousness – works within approved budget; develops and implements cost saving measures; contributes to profits and revenue; conserves organizational resources.
- Motivation – sets and achieves challenging goals; demonstrates persistence and overcomes obstacles; measures self against standard of excellence.
- Planning/Organizing – prioritizes and plans work activities; uses time efficiently; plans for additional resources; sets goals and objectives; organizes or schedules other people and their tasks; develops realistic action plans.
- Professionalism – approaches others in a tactful manner; reacts well under pressure; treats others with respect and consideration regardless of their status or position; accepts responsibility for own actions; follows through on commitments.
- Quality Management – looks for ways to improve and promote quality; demonstrates accuracy and thoroughness.
- Innovation – displays original thinking and creativity; meets challenges with resourcefulness; generates suggestions for improving work; develops innovative approaches and ideas.
- Oral Communication – speaks clearly and persuasively in positive or negative situations; listens and gets clarification; responds well to questions; demonstrates good presentation skills; participates effectively in meetings.
- Written Communication – writes clearly and informatively; edits work for spelling and grammar; varies writing style to meet needs; presents numerical data effectively; able to read and interpret written information.
- Understanding of clinical trial processes and needs
- Excellent transferrable skills
- IT literacy, particularly in Word, Excel, and PowerPoint
- Knowledge of ICH GCP
- Assisting with reconciliation of the TMF
- Raising Purchase Orders (POs) for Clinical Departmental related expenditure
- Effective and efficient departmental administration
- Previous experience of working in Clinical Research or the Pharmaceutical Industry
- Understanding of the clinical trial process and drug development
- Excellent organisation, communication and customer service skills.
- Comfortable and confident in dealing with a wide range of people.
- Able to carry out administrative duties with accuracy and speed.
- Advanced proficiency in IT, Microsoft Office software (Word, Excel and PowerPoint) preferred.
- Experience of administrative support in a busy environment
- Experience of using the DIA Trial Master File Reference Model