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Clinical Project Manager

Location: Anywhere in the U.S. (Remote Position) – about 10-20% of travel once pandemic restrictions are resolved.

Xentria is a patient-centric biotech company focused on novel biologics and biosimilars. Our first program is XT MAB 16, a monoclonal antibody for sarcoidosis. XT MAB 16 has received Orphan Drug Designation and is currently in a Phase 1 study.


Xentria is seeking an experienced and energetic Clinical Project Manager (CPM) to join their Clinical Operations team. This candidate will report directly to the Vice President of Research & Development. The CPM will be responsible for overseeing all aspects of clinical trial activities on assigned studies. This will include managing outside vendors in the execution of clinical trials and development of relationships between the Sponsor and site personnel.



Essential Duties and Responsibilities

  • Essential Duties and Responsibilities include the following. Other duties may be assigned.
  • Plans and implements clinical research studies within budget and on schedule.
  • Manages activities of vendors and investigators to ensure compliance with the study protocol and overall clinical objectives.
  • Coordinates and leads study team meetings and update the Clinical Team on timelines and milestones for the study.
  • Contributes to the development of study documentation including protocol review, creating study manuals, ICFs, and designing CRFs.
  • Participates in study site selection; review and update site-specific consent forms; track patient accrual and study progress via standard reports; assure patient eligibility; document protocol deviations/violations; and manage adverse event reporting.
  • Oversees clinical monitoring from site qualification to site closure visits and assure the integrity of clinical data with respect to
  • accuracy, accountability, and documentation through review of case report forms, source documents, and medical records.
  • Evaluates and analyzes clinical data.
  • Provides input to Clinical Study Reports and Investigator Brochures, including data cleaning, listing review, and report writing.
  • Reviews and negotiates contracts & budgets.
  • Ensures that study documentation is maintained according to applicable regulations, industry-accepted standards, and SOPs that govern clinical studies both in the field and in-house.
  • Develops SOPs, work instructions, and standardized forms to define Clinical Operations processes within a small but growing team.
  • Collaborates with Clinical, Regulatory, and Quality team members to ensure compliance of department/study activities with FDA/EMA regulations, guidelines, and principles of ICH GCP and company SOPs.
  • Up to 25% domestic and/or international travel expected with routine travel to Chicago office.

Supervisory Responsibilities

No direct reports associated at this time.



Competencies

  • Teamwork
  • Professionalism
  • Judgement
  • Ethics
  • Interpersonal
  • Project Management

Qualifications

To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.


  • Demonstrates advanced knowledge of and appropriate experience of relevant software packages (e.g., Microsoft Project, Word, Excel) and the company’s systems and programs.
  • Experience in rare disease, orphan or neurology is highly desirable.
  • Must have strong oral and written communication skills with monitoring, study management, and SOP-development experience.
  • Must be highly adaptable, proactive, deadline- and detail oriented, and will maintain a high level of professional expertise through recent industry training and familiarity with clinical research publications.
  • Ability to work independently under general direction in a fast paced environment



Education and/or Experience Required

Required:


  • B.S. and/or M.S. degree in a scientific discipline
  • At least three years of direct global clinical project management experience in the pharmaceutical or biotech setting
  • Proficient to expert knowledge of GCP and EMA/FDA regulations
  • Experience overseeing multiple vendors and CROs

Preferred:


  • Experience with early access programs
  • PMP certification or equivalent


Computer Skills

Microsoft Word, PowerPoint and Excel.  Technical software skills and experience, including ERP systems, Business Intelligence Tools, and experience optimizing data analytics to enact business decisions. 



Physical Demands

While performing the duties of this Job, the employee is frequently required to stand; walk; sit and talk or hear. The employee must occasionally lift and/or move up to 20 pounds. 



Work Environment

The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job.  The noise level in the work environment is usually moderate.



AAP/EEO Statement

Equal Opportunity Employer Minorities/Women/Veterans/Disabled.


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About Us

Headquartered in Chicago, the company is dedicated to R&D, clinical science, manufacturing, and commercialization while striving to treat the clinical and social disease burdens while fostering sustainable growth. Xentria, whose name stems from the word “centrality” was founded in 2020 and is an innovative biopharmaceutics company whose primary focus is to build an expansive product pipeline of cost-effective and efficacious treatments to address critical unmet needs for patients suffering from rare, immunologic, metabolic, and musculoskeletal diseases, as well as oncology.

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