Basic Information

Job ID 16079

Description

Company: MDNA Life Sciences
Position: Clinical Trial Manager
Location:  Newcastle/ Hybrid
Vacancy Type:  Permanent  
Salary:  Competitive

Ashfield Engage are delighted to be working with MDNA to recruit a Clinical Affairs Manager.

In 2001 scientists from the Universities of Newcastle and Lakehead University, in Canada, collaborated to make the discovery that mitochondrial DNA can be used to identify biomarkers for the recognition of disease in humans. This was the beginning of the MDNA journey. A journey that has led to the creation of a growing portfolio of revolutionary tests for the detection of hard to detect diseases like endometriosis.  This is a fantastic opportunity to work with a company driven by innovation to create an ever-growing portfolio, with the goal of early disease detection and putting an end to unnecessary surgical procedures, unnecessary pain and uncertainty affecting patients across the world.

The Clinical Affairs Manager is responsible for management of multiple studies including the planning, implementation, oversight, project management and completion of clinical studies conducted by MDNA and its contractors. This role serves as the project lead for studies of moderate to high complexity from protocol development through study conduct and closeout in compliance with Good Clinical Practices, IVDR, and all Global, National and Local Regulations.

The successful candidate will be capable of reviewing needs of stakeholders, aligning to requirements and designing and implementing a system for effective management and coordination of clinical studies to support MDNA’s pipeline of products.  This is a ground-up opportunity to contribute to and execute on a vision of excellence in clinical study management.  The Clinical Affairs Manager must be prepared to build out and manage a highly effective team in concert with MDNA’s product development pipeline. 

Responsibilities

  • Accountable for the execution of clinical studies, or assigned portion of clinical studies while optimizing speed, quality and cost of delivery and compliance with standard processes, policies, and procedures.
  • Collaborate with other functional groups within the company where necessary to support milestone achievement and to manage study issues and obstacles.
  • Preparation of all necessary documentation and systems to support the clinical study design.  
  • Serving as the primary clinical study contact with the sites and/or contractor
  • Monitoring study performance against contract and expectations and according to key performance metrics
  • Design, implementation, and management of study database 
  • Ensuring compliance with study tools, training materials and standard processes, policies, and procedures.
  • Prepares and/or reviews study-related or essential study start-up documents as they relate to the assigned clinical trials (e.g., Clinical Protocols, Informed Consent forms, Investigator Brochures, Monitoring Plan, Laboratory Manual, Patient Diary, Clinical Site Procedures Manual, Case Report Form (CRFs), CRF Completion Guidelines and other relevant study plans and charters).
  • Maintains a working knowledge of all study related SOP’s
  • Serves as a Clinical Project Manager ensuring that the parties meet or exceeds the timelines and deliverables assigned to the study team
  • Oversees/leads study-specific study management resources
  • Manages relationships with sites/PIs. other study related vendors, including CRO’s.
  • Knowledge of established project management standards used to develop and maintain integrated project plans (scope/work packages, time/schedule, cost/material and human resource, quality, communication/escalation, risk, value) and organizes/facilitates meetings and discussions as needed.
  • Defines, tracks and reports schedule attributes such as durations, interdependencies, milestones, critical path and other key deliverables including efficiency and effectiveness of plans and staff.
  • Proactively identifies and manages risks and issues (including a log, mitigations, and contingencies) to ensure cost effective timely delivery of the project including escalation if needed
  • Plans and maintains high quality standards to meet compliance requirements.

Required Knowledge, Skills & Abilities

  • In depth knowledge of, and skill in applying, applicable clinical research regulatory requirements, e.g.., Good Clinical Practice (GCP), Human Tissue Authority and ISO 20916:2019
  • In depth diagnostic and protocol knowledge
  • Strong communication and interpersonal skills, including good command of English language and technical writing
  • Demonstrated ability to deliver results to the appropriate quality and timeline metrics
  • Strong software and computer skills, including MS Office applications
  • Ability to work effectively, independently with multi-level teams, manage multiple projects and work in a fast paced and changing environment.

Minimum Required Education & Experience 

  • Bachelor's degree in life sciences or related field
  • Clinical Research Coordinator Certification or equivalent preferred.
  • Minimum 5 years' clinical research experience including experience in clinical operations; or equivalent combination of education, training, and experience, preferably with some in a commercial IVD organization.
  • Experience/Knowledge in IVD products, and Clinical Laboratory processes
  • Minimum 2 years Project management experience desirable using MS Project or similar system. PMP Certification is an asset
  • Minimum 2 years experience successfully leading a project team

Please note if you have not heard from a member of the recruitment department within 7 days your application has been unsuccessful at this stage.

Thank you for your interest.