Senior Clinical Trial Associate

About AskBio
Asklepios BioPharmaceutical, Inc. (AskBio), a wholly owned and independently operated subsidiary of Bayer AG acquired in 2020, is a fully integrated AAV gene therapy company dedicated to developing life-saving medicines that have the potential to cure genetic diseases. The company maintains a portfolio of clinical programs across a range of neuromuscular, central nervous system, cardiovascular and metabolic disease indications with a clinical-stage pipeline that includes therapeutics for Pompe disease, Parkinson’s disease and congestive heart failure, as well as out-licensed clinical indications for hemophilia and Duchenne muscular dystrophy. AskBio’s gene therapy platform includes Pro10™, an industry-leading proprietary cell line manufacturing process, and an extensive AAV capsid and promoter library. With global headquarters in Research Triangle Park, North Carolina, and European headquarters in Edinburgh, UK, the company has generated hundreds of proprietary third-generation AAV capsids and promoters, several of which have entered clinical testing. Founded in 2001 and an early innovator in the gene therapy field, the company holds more than 850 patents in areas such as AAV production and chimeric and self-complementary capsids. Learn more at www.askbio.com.
Position Overview

The Senior Clinical Trial Associate provides support for the creation and maintenance of paper and/or electronic clinical trial records including the Trial Master File with a focus on maintaining inspection readiness throughout the lifecycle of an individual clinical trial or a clinical development program. The Senior Clinical Trial Associate is an integral part of the study/trial team in assuring that all clinical trial paperwork is handled appropriately and that assigned TMFs are complete, accurate, and timely.

We are excited about our next Senior Clinical Trial Associate to join the AskBio team!

Job Responsibilities
The Senior Clinical Trial Associate will:

  • Support the clinical trial manager(s) and overall study team for all phases of study conduct (feasibility, planning and start up, conduct/maintenance, and closeout).
  • Assist with maintaining study status updates on agreed cadence (examples of activities tracked include IRB approvals, regulatory document collection, patient enrollment, monitoring status).
  • Provide support for inspection readiness by formatting, proofreading documents and contributing to the establishment, maintenance and quality control of the Trial Master File (maintained internally or by CROs).
  • Assist clinical trial managers with preparation, handling, distribution and tracking of clinical trial supplies and other study supplies.
  • Prepare and maintains investigator information tracker for clinical trial operations, working with in house or vendor staff.
  • Support compilation of documentation for CSR appendices based on clinical trial protocol and clinical study report (CSR) requirements.
  • Assist in the development of the structure of Trial Master File and filing system and supports study team in maintaining up to date study documents; assists with or independently conducts Quality Control review of in house or vendor Trial Master File(s).
  • Coordinate timely resolution of document issues with the documents from study sites, data management centers, and other trial collaborators.
  • Generate regulatory compliant Certified Copies when/as needed.
  • Create Metrics Reports to assist with trial oversight and to demonstrate quality and completeness of the TMF as well as other study documents.
  • Assist with planning, organization and conduct of external meetings such as Investigator Meetings.
  • Review regulatory documents to ensure completeness in accordance with Sponsor requirements, ICH/GCPs, CFR, EMA, MHRA and other health authority requirements/regulations.
  • Organize and provides oversight of study contracts, budget documents, billing and invoices – supports study team to process all study financial documents to ensure timely processing, payment, and tracking; assists with budget reconciliation.

Required Education & Experience

  • Associate’s degree/Bachelor’s degree or + 3 years’ experience.
  • Minimum 3 years’ experience in Clinical Trial Support.

Preferred Skills & Experience

  • Familiarity and experience with clinical trial Records Management and Trial Master File requirements and practices.
  • Prior experience with setting up and managing study/program level tracking and processing contracts/resultant invoices for payment and tracking.
  • Significant knowledge of the drug development process, relevant regulatory requirements for drug approval and documentation required for Inspection Readiness.
  • Demonstrated organizational skills and attention to detail.
  • Ability to work independently and rearrange work assignments as priorities/business needs change; manage multiple assignments with competing and aggressive timelines.
  • Proficient computer skills (e.g. Microsoft Word, Excel, PowerPoint).
  • Demonstrated ability to build successful working relationships and effective stakeholder management in an environment that requires diverse educational and functional expertise.
  • Excellent verbal and written communications skills; able to communicate proactively and effective.