Senior Clinical Trial Manager

The candidate will be instrumental in supporting Cara’s clinical program on the development of a symptomatic treatment for pruritus in a variety of patients. The candidate will have hands-on responsibility with the planning and management of late stage clinical phases of our pruritus program. Management of CRO relationships and internal company timelines is a key aspect of this position.

 

Responsibilities

  • Responsible for the overall operational setup and execution of specific clinical studies related to our pruritus program from study concept through study completion, while adhering to scope and schedule requirements as per corporate goals
  • Manage day-to-day activities associated with the conduct of Phase 3 clinical studies from implementation to study closure (Note: as the pruritus program evolves, this may also involve the additional management and coordination of Phase 1 and Phase 2 clinical trials, which may entail management of several clinical trials at time).
  • Alongside with clinical scientists, lead internal project or trial team meetings as applicable
  • Manage study deliverables and timelines including, but not limited to: clinical monitoring, data management, statistics, medical writing, medical monitoring, and safety to ensure proper conduct and timely completion of all phases of the project(s)
  • Manage and assess protocol deviation documentation and assess with team need for protocol amendment if applicable
  • Participate in establishment of strategies for patient retention and recruitment as applicable
  • Ensure adequacy of protocol from a clinical operation perspective and proper training of all study team members for adequate execution of such protocol
  • Prepare team (CRO/internal) for interim analysis
  • Coordinate and present at investigator meetings and CRA workshops, as required
  • Manage vendors (ie, selection, negotiation, implementation of work orders and change to work orders) and ensure execution of deliverables within approved clinical trial budget and timelines. Work alongside with program manager
  • Work with site liaison specialist to facilitate the identification of prospective investigative sites and participate in final investigative site selection or liaise with vendors to ensure quality site selection
  • Ensure adequate site selection focusing on appropriate subject enrollment and appropriate CRA resource allocation
  • Aware of both internal and external business environments with the ability to assess impact on clinical studies and make modifications, as necessary
  • Guide and oversee study protocol to anticipate potential problems that may arise during the clinical trial in close collaboration with a CRO.  A clear understanding of the study objectives is mandatory to ensure appropriate and accurate study performance and oversight.
  • Create and lead the development of study plans and study-specific working practices
  • Provide support in the planning, design, and execution of required documentation in compliance with project plans, federal regulations, and ICH/GCP, such as monitoring plan, study management plan, recruitment materials and so on
  • Provide support to ensure compliance with regulatory requirements and SOPs to ensure a continued state of inspection readiness
  • Interacts with finance, research and development, marketing, manufacturing, regulatory and other relevant departments as appropriate
  • Provide effective and clear communication between study sites, CRO and internal study team members to ensure successful completion of clinical trials
  • Ensure adequate monitoring to meet study objectives and provide data quality
  • Act proactively to identify issues and resolution for successful completion of study
  • Train CRAs as applicable and review/approve monitoring reports alongside with Cara’s lead CRA
  • Acts as point of escalation for study related issues alongside with clinical scientists and executives
  • Prepare or provide input/review for clinical and regulatory documents (e.g., Protocol, Informed Consent Form, Case Report Forms and patient worksheets, Investigator’s Brochure, data management plan and edit specifications, monitoring plan, and Clinical Study Report) as appropriate
  • Ensure collection of proper documents for compilation/reconciliation of Trial Master File and perform regular review of TMF as applicable; working knowledge of the TMF Reference Model a must
  • Visit clinical sites as needed
  • Additional tasks will involve planning and participation at external meetings such as Investigator Meetings, KOL, scientific meetings as applicable

Requirements:

  • BA/BS/MS degree or equivalent education
  • 10+ years in the pharmaceutical or biotech industry with proven experience as a clinical trial manager
  • Clinical monitoring experience desirable
  • Experience with the conduct and management of both Phase 1, 2 and Phase 3 trials is required with strong emphasis on Phase 3; experience with the conduct of global trials is desirable.
  • Experience within the therapeutic area of pruritus and/or dialysis patients is desirable with experience in patient reported outcome measures
  • Excellent written, verbal communication and presentation skills in small and large group settings a must
  • Excellent organizational skills and ability to communicate clearly and efficiently required
  • Excellent knowledge of ICH/GCP and regulatory guidelines/directives for compliance with FDA, EMA and other international regulatory agencies, as required
  • Strategic thinking, ability to work well with others, maintain a team spirit and provide good clinical judgment
  • Effective at problem solving and must demonstrate leadership skills in order to direct clinical team in study preparation and execution.
  • Ability to effectively multi-task and prioritize
  • Ability to travel ~20 % of time
  • Financial budgeting and forecasting skills
  • Solid computer skills requirement of MS applications including (but not limited to) MS Project, Word, Excel, Power Point
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