Clinical Trial Manager

Job Title:          Clinical Trial Manager

Reports to:       Vice President, Clinical Affairs

Location:          Dallas, TX – Remote work may be an option for those unable to relocate

 

Position Summary:

Osteal Therapeutics, Inc. is a clinical-stage company developing a novel pipeline of drug/device combination therapies for the treatment of musculoskeletal infections and their consequences. Our lead investigational candidate, VT-X7 was granted Orphan Drug, FastTrack and Qualified Infectious Disease Product designations by the FDA and is currently in Phase 2 comparative trials for the treatment of Periprosthetic Joint Infection (PJI). With a robust pipeline of additional indications and therapeutic candidates, we anticipate rapid and sustained growth.

Osteal is looking for an experienced Clinical Trial Manager (CTM) to design and manage all aspects of our current Phase 2 clinical program. Reporting to the VP, Clinical Affairs, the CTM will be a critical member of the clinical team, providing operational direction and leadership in the development, implementation, and oversight of a robust clinical trial program to support Osteal’s current and future products. This is an opportunity for an experienced manager to play a central role in planning and executing trials that will be critical to Osteal’s success.

 

Essential Responsibilities:

  • Plan and execute all aspects of clinical trials according to clinical protocols and applicable standard operating procedures and regulations

  • Establish and maintain relationships with clinical trial sites to drive site activation and trial enrollment and ensure achievement of company objectives

  • Work with the clinical affairs team and key opinion leaders on the development of clinical investigation protocols, case report forms, and informed consent form templates

  • Lead trial progress reporting to executive leadership to ensure clinical trials meet company timelines and objectives

  • Work with CROs and vendors to ensure deliverables are met and to establish effective communication and relationships for efficient workflows

  • Prepare and/or review trial-related documents including trial logs, newsletters, manuals, etc.

  • Assist with the development and management of trial budgets and timelines according to established objectives

  • Assist in the development and delivery of trial-required training

  • Assist in the development of necessary work instructions and standard operating procedures for developing and executing clinical trials 

Experience/Skills:

  • Bachelor’s degree with at least 5 years of relevant clinical trial management experience in industry or at a clinical research center

  • Successful track record of managing all phases of pharmaceutical and/or medical device clinical trials

  • Experience in orthopedics preferred but not required

  • Strong working knowledge of FDA and GCP regulations

  • Experience working with a variety of electronic data capture systems and knowledge of project management software

  • Experience creating and managing study budgets to plan

  • Experience in IRB submissions and site budgeting/contracting

  • Experience in working with and managing CROs

  • Self-starter with good written and oral communication skills

  • Ability to multi-task and prioritize tasks according to trial needs

  • Willingness and ability to travel regularly (up to 20%)