Clinical Trials Administrator

About MeiraGTx

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

The primary purpose of the Clinical Trials Administrator (CTA) is to administer, maintain and co-ordinate the logistical aspects of clinical trials in compliance with Good Clinical Practice (GCP) and relevant Standard Operating Procedures (SOPs).  They also act as a pivotal point of contact & support for the clinical trial team.

Major Activities

The CTA will be involved in most activities in preparation for study set up, conduct and completing a Clinical Trial which usually includes:

  • Arranging & participating in the organisation of Investigator Meetings & Study Team Meetings.
  • Assist with the Ethics / Regulatory Submissions; keep a track of submissions & approvals for the study
  • Prepare for the distribution of protocols, Investigator Brochures and CRFs, including keeping track of and re-ordering supplies
  • 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)
  • Managing and maintaining study documents & trial supplies e.g., Patient Information Sheets, Patient Diaries, Lab Kits & Medical equipment for sites.
  • Preparing essential clinical trial documentation, distributing, tracking, and filing of documents on return
  • 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.
  • Setting up of finance systems accurately, processing invoices & tracking payments for the trial for investigator payments
  • For studies allocated, with the Trial Master File Manager, co-ordinating archiving of study documentation
  • Assisting with CRF Design
  • Arranging translation of patient documents
  • Maintain understanding of Good Clinical Practice
  • Contribute to the development of the clinical quality management system through the development and review of Standard Operating Procedures and supporting documents

Key Performance Indicators

  • Ensuring the Trial Master Files are appropriately maintained
  • Ensuring tracking systems for trial related paperwork remain up to date

Key Job Competencies

  • Understanding of clinical trial processes and needs
  • Excellent transferrable skills
  • IT literacy, particularly in Word, Excel, and PowerPoint
  • Knowledge of ICH GCP

 Job Responsibilities

  • N0 direct reports
  • Financial authority for submitting clinical team expenses and raising Purchase Orders on request

Job background

  • University degree or equivalent in health sciences, nursing or pharmacy or related field
  • Previous experience of working in Clinical Research or the Pharmaceutical Industry
  • Knowledge of the Industry/Clinical trial process and drug development
  • Experience of administrative support in a busy environment
  • Experience of using the DIA Trial Master File Reference Model

Trial Master File Administrative Support

About MeiraGTx

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.

Major Activities

TMF Related

  • 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

Departmental activities

  • 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.

Job Responsibilities

  • 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

Job Background

  • 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

 

Clinical Endpoints Specialist

About MeiraGTx

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

Contribute to the execution of gene therapy projects by working with clinical and regulatory teams to ensure novel endpoints and assessments are appropriately validated and can be scaled up for use in multiple sites. They will partner with MeiraGTx project teams and management to effectively identify and resolve problems or concerns.

Major Activities

  • Work closely with the clinical and regulatory teams to understand regulatory requirements for validating and implementing study endpoints
  • Working with property management companies to secure potential research facilities for the duration of projects
  • Ordering and arranging the shipping of supplies to sites positioned globally
  • Work closely with clinical sites to manage the set up and installation of assessment devices
  • Co-ordinate the manufacturing components required to up-scale assessment capability to multiple sites
  • Good understanding of procurement, RFI/RFP, vendor selection, contracts, management, set up and tracking of performance.
  • Ensure assessment capability is in place to coincide with study start up
  • Cost management
  • Ensure activities are conducted in compliance with applicable regulations and Good Clinical Practice
  • Understand the technical requirements for the assessments, their mode of operation, and how that translates to clinical need
  • Train staff and troubleshoot on the assessment capability
  • Develop protocols to ensure reproducibility and reliability of assessments across sites
  • Co-ordinate endpoint adjudication activities where required
  • Compile and maintain project-specific status reports;
  • Create and maintain project timelines

Key Performance Indicators

  • Ensuring sites can participate fully in clinical studies with respect to their ability to assess endpoints
  • Ensuring all necessary documentation and results are available to support licensing applications with respect to study endpoints
  • Ensuring senior management and tracking systems for trial related paperwork remain up to date

 Key Job Competencies

  • Understanding of clinical trial processes and needs
  • Excellent transferrable skills
  • IT literacy, particularly in Word, Excel and PowerPoint
  • Knowledge of ICH GCP
  • Adaptable, flexible, and inventive in planning and execution of study related tasks
  • Excellent communication skills

 Job Responsibilities

  • Direct reports – none
  • Financial authority for submitting clinical team expenses and raising Purchase Orders on request

Job background

  • University degree or equivalent in sciences, engineering, nursing or pharmacy or related field
  • Previous experience of working in Clinical Research or the Pharmaceutical Industry
  • Knowledge of the Industry/Clinical trial process and drug development
  • Experience of working with industry regulators (MHRA/FDA), is beneficial but not required

Experience of using the DIA Trial Master File Reference Model, is beneficial but not required

Clinical Project Manager

About MeiraGTx

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

Contribute to the execution of gene therapy projects per development plan, from initiation through to closeout. Ensure that all clinical study management and project deliverables are completed on time and within budget and in accordance with SOPs, policies and practices.

Major Activities

  • The CPM is accountable for leading with success the execution of data generation activities for projects assigned by the Associate Director – Clinical Programme Management or Director Clinical Operations
  • The CPM serves as the single point of end-to-end accountability for assigned projects, leading the Study Management Team for global, regional or complex studies, interfacing with the Clinical Teams, functional representatives, stakeholders or other internal/external sponsors, external service providers e.g., contract research organisations (CRO)
  • Primary accountability at the trial level. This includes all project activities staring from protocol development to delivery of the final Clinical Study report (CSR) or other deliverable(s), according to planned milestones, within budget, and with high quality standards per company procedures and regulatory requirements
  • CPM provides operational leadership to the execution plan and defines risk mitigation strategies and ensures implementation thereof. Co-ordinates activities in the Trial Team and ensuring ad-hoc trial Working Groups are organized as needed, driving issue identification and resolution, contingency planning and decision making
  • Support project team members to be compliant with current ethical and regulatory guidelines and requirements
  • Support budget negotiation and trial agreements with sites
  • Oversee program budget and provide input
  • Develop project management plan and be responsible for cross functional project meetings
  • Liaise with data management team and external vendors to ensure data is reported accurately and in a timely manner for the responsible program
  • Responsible for outsourced vendor management oversight and invoicing
  • Responsible for the communication of timelines across the team members to ensure efficient production, scheduling and delivery of project
  • Accountable for oversight of TMF review and maintenance and for clinical operations inspection readiness
  • Collaborate internally and externally to ensure clinical milestones are achieved and to ensure issues and obstacles are managed accordingly
  • Tracks project progress against timelines. Monitors patient recruitment rate to ensure that target enrollment will be met across the allocated region/countries
  • Provide regular status updates to Clinical Trial Team and Management. Ensures required reports are generated and available for real time tracking of project status
  • Mitigate clinical risk by problem solving and contingency plan development
  • Oversee site and team communications and compliance with regulations and SOPs
  • Oversee and support quality assurance
  • Supervise the implementation of corrective action plans
  • Oversee activities outsourced to CRO
  • Identify and contribute to compilation and delivery of study associated documentation (protocols, IB, ICF, etc.)
  • Review trial data and procedures ensuring good quality data
  • Establish and maintain good communication and relations with stakeholders in the clinical programmes including investigators, CROs, and regulatory consultants
  • Contribute to the development of the clinical quality management system through the development and review of Standard Operating Procedures and supporting documents.
  • Provide assistance and participate in audits and inspections

Key Performance Indicators

  • Clinical trial management of MeiraGTx Gene therapy programmes using industry standard project management tools and training materials and compliance with Good Clinical Practice, standard processes and procedures.
  • Implement continuous improvement activities for gene therapy programmes.
  • Co-ordinate outsourced vendor agreements and costings

Key Job Competencies

  • Ensure regulatory compliance in terms of MHRA, FDA and EU framework.
  • Understand and adhere to the principles of ICH GCP and regulatory requirements in both the EU and US.

Job Responsibilities

  • Direct Reports: none
  • No financial authority

Job background

  • Educated to Degree level (or equivalent) in a Biological Science discipline.
  • 5+ years of clinical trial management experience to include trials of an advanced medicinal product.
  • 2+ years of clinical trial management experience in a commercial setting.