Clinical Study Manager

 

About Us

Asklepios BioPharmaceutical, Inc. (AskBio) is a privately held, clinical-stage gene therapy company founded in 2001 based on the work of adeno-associated virus (AAV) gene therapy pioneers, Jude Samulski, PhD, and Xiao Xiao, PhD. We are driven to change lives with every clinical advancement and turn hope into cures with new possibilities for genetic medicine. We currently have clinical trials ongoing for late-onset Pompe disease and congestive heart failure.

AskBio is headquartered in Research Triangle Park, North Carolina, a thriving biotechnology hub, and has additional research and development facilities in Edinburgh, Scotland, and gene therapy manufacturing in San Sebastian, Spain.

We are excited for our next CLINICAL STUDY MANAGER to join the AskBio team!

About the Role
The Clinical Study Manager (CSM) provides oversight and risk management for clinical research activity. The CSM will verify that the rights and well-being of human subjects are protected, trial data is accurate, complete and verifiable, and that our trials are conducted in compliance with applicable regulatory requirements.

Responsibilities and Accountabilities

  • Serve as core team member on project teams
  • Conduct feasibility assessments of planned clinical trials
  • Oversee third-party vendors, including contracts and budgets
  • Quality assurance for Trial Master File and regulatory documents
  • Conduct activities as outlined below to ensure clinical trials are adequately monitored (as stated in ICH guidelines)
  • Act as main line of communication between AskBio study team and the investigator/site
  • Verify that the investigator follows approved protocol and all approved amendment(s), if any
  • Ensure that the investigator receives the current Investigator’s Brochure, all documents, and all trial supplies needed to conduct the trial properly and comply with applicable regulatory requirement(s)
  • Ensure that the investigator and the investigator’s trial staff are adequately informed about the trial and are performing the specified trial functions, in accordance with the protocol and any other written agreement between AskBio and the investigator/institution, and have not delegated these functions to unauthorized individuals
  • Verify that the investigator is enrolling only eligible subjects
  • Report the subject recruitment rate and protocol specific metrics
  • Verify that the investigator provides all required reports, notifications, applications and submissions and that these documents are accurate, complete, timely, legible, dated and identify the trial
  • Check the accuracy and completeness of CRF entries, source documents and other trial-related records against each other – overseeing all outsourced monitoring and data management activities
  • Inform the investigator/vendor of any CRF entry error, omission or illegibility. Ensure appropriate corrections, additions or deletions are made, dated, explained (if necessary) and initialed by the investigator or by a member of the investigator’s trial staff who is authorized to initial CRF changes for the investigator. This authorization should be documented
  • Determine whether all adverse events (AEs) are appropriately reported within the time periods required by GCP, the protocol, the IRB/IEC, AskBio, and applicable regulatory requirement(s)
  • Determine whether investigator is maintaining essential documents as required by applicable regulations
  • Communicate deviations from protocol, SOPs, GCP and applicable regulatory requirements to the investigator and take appropriate action designed to prevent recurrence of detected deviations
  • Support development of subject recruitment plans
  • Evaluate the quality and integrity of site/vendor practices – escalating quality issues as appropriate
  • Qualify and oversee external vendors that provide clinical research services
  • Responsible for partnering and contributing to Target Product Profile (TPP), evidence generation strategies, and project per-stage gate process
  • Attend all team meetings and serve as single point of contact for communication between project team and investigational sites
  • Assess, communicate and manage risks associated with clinical development plan
  • Communicate progress and milestone status to leadership, R&D partners and others
  • Organize multi-disciplinary team and engage necessary disciplines to address project goals and objectives
  • Work cross-functionally to assess project risks, product safety and efficacy on projects
  • Survey the literature to identify and compare competitive product performance and safety risks
  • Provide input and reviews for study protocols and reports from clinical studies
  • Identify external labs (academic, CRO), as needed, to execute clinical studies. Initiate contract and audits, if necessary
  • Participate in reviews and provide recommendations for business development opportunities
  • Perform other activities as assigned by the Chief Medical Officer and senior management

About You

  • Bachelor’s degree in a health care or relevant scientific field
  • Certification from SOCRA or ACRP or at least two years of clinical research experience in pharma, biotech or contract research organization
  • Demonstrated ability to work efficiently with different personalities and styles and prioritize activities based on ambiguous or quickly changing information and environments is critical
  • Ability to multitask among multiple projects and teams and work independently in a fast-paced, highly interactive environment
  • Excellent interpersonal skills with the ability to interact effectively with people, internally and externally, is required

Live an AskLife
We offer a competitive total rewards package. Are you our next great discovery?