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Associate Clinical Project Manager

REGENXBIO Inc


Location:
Rockville, Maryland
Date:
11/16/2017
2017-11-162017-12-16
Job Type:
Employee
Categories:
  • Clinical Operations
REGENXBIO Inc
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Job Details

ABOUT THE ORGANIZATION      

REGENXBIO is a leading biotechnology company focused on the development, commercialization and licensing of recombinant adeno-associated virus (AAV) gene therapy. Our NAV Technology Platform, a proprietary AAV gene delivery platform, consists of exclusive rights to more than 100 novel AAV vectors, including AAV7, AAV8, AAV9 and AAVrh10. Our mission is to transform the lives of patients suffering from severe diseases with significant unmet medical needs by developing and commercializing in vivo gene therapy products based on our NAV Technology Platform. We seek to accomplish this mission through a combination of our internal development efforts and the efforts of our third-party licensees (NAV Technology Licensees).

 

Our most advanced internally developed candidates include programs for the treatment of two severe and rare genetic diseases, homozygous familial hypercholesterolemia (HoFH) and Mucopolysaccharidosis Type I (MPS I). In addition, we have a preclinical program for wet age-related macular degeneration (wet AMD) as well as two additional research programs. REGENXBIO plans to build internal gene therapy franchises in the metabolic, neurodegenerative and retinal therapeutic areas, and develop multiple product candidates in these and other areas.              

 

DESCRIPTION    

The Associate Clinical Project Manager (ACPM) will support the planning and management all aspects of clinical operations for clinical projects. Based on complexity and scope, the ACPM may also serve as the point of contact for smaller trials based on size and scope. The ACPM will manage vendors, budgets, resources, investigational sites, and any key project deliverables as specified by processes, ICH/GCP guidelines and alignment with clinical development strategies and goals. Matrix management of functional area representatives via the clinical trials teams will be required.

 

PRIMARY RESPONSIBILITIES

 

  • Lead smaller sized projects as the sole Project Manager, when needed.
  • Provide support in the management of the operational aspects of clinical trials
  • May be asked to review study budget and double check considerations
  • May contribute to the overall project timing of the protocol concept sheet and protocol, CRF and, Clinical Study Report preparation, IND submission, as appropriate
  • Will attend cross functional team meetings, and CRO calls as required
  • May prepare metrics and updates for management, as assigned
  • Collaborate with Clinical Project Manager to execute clinical trial
  • Participates in CRO/vendor selection process for outsourced activities
  • Participates in the selection of potential sites in collaboration with CPM
  • May prepare, review/approve study-related documents including, not limited to (e.g., Monitoring Plan, Laboratory Manual, Patient Diary, Clinical Site Procedures Manual, Pharmacy Manual, CRF Completion Guidelines)
  • Will submit as well as oversee the trial-related and essential documents to the Trial Master File
  • Participates in the development, review, and implementation of departmental SOPs and processes
  • Recommends and implements innovative process ideas to impact clinical trials management
  • Organizes and manages investigator meetings, and other trial­ specific meetings
  • Serves as a liaison and resource for investigational sites
  • May prepare and review site study documents (informed consent template and study tools/worksheets), investigator contracts, and site payments
  • Participates in the selection, training, and evaluation of study personnel (contract and internal) to ensure the efficient operation of the function
  • Complete minutes in required meetings
  • Assume responsibility for administrative duties that are part of clinical project management
  • Other duties as assigned.

 

POSITION REQUIREMENTS          

SKILLS, KNOWLEDGE AND ABILITIES REQUIRED

 

  1. A 4-year degree from a university in a Life Science preferred
  2. 3 years of progressive experience in clinical operations execution, with a minimum of 2 years of site management and monitoring
  3. Proven problem solving and decision-making skills
  4. Strong interpersonal and negotiation skills
  5. Ability to navigate in times of ambiguity
  6. Ability to work under moderate oversight of CPM or AD/D Clinical Operations


TECHNICAL SKILLS

Familiar with advanced concepts of clinical research and able to work effectively in a team/matrix environment

Knowledgeable of clinical research operations, including interpretation and implementation of FDA regulations/ICH guidelines, is required

 

WORKING CONDITIONS AND/OR PHYSICAL REQUIREMENTS

 

Ability to sit or stand for extended periods of time

Unusual sensory requirements

The ability to travel up to 25% of the time, sometimes internationally

 

 

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