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Clinical Trial Manager

Crestovo LLC


Location:
Cambridge, Massachusetts
Date:
06/08/2017
2017-06-082017-07-08
Categories:
  • Clinical Operations
Crestovo LLC
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Job Details

The individual who fills this position will have responsibility for operations and oversight of clinical trials within the Company’s clinical development program. He/she will have experience and capability in managing clinical trials using both the in-sourced and out-sourced (CRO) model. The level of independence and scope of responsibilities assigned initially will be based on the individual’s experience

POSITION RESPONSIBILITIES

  • Provide operational leadership for assigned projects within a clinical development program.
  • Oversee and mange regulatory collection from clinical sites. Complete initial review and approval of site documents including ICF and essential documents.
  • Identify, select and monitor performance of investigational sites for clinical studies against defined milestones and timelines to assure that all deliverables are met.
  • Track and report on progress of study metrics including, but not limited to, site activation, patient enrollment and monitoring visits.
  • Prepare accurate and timely visit reports from all site visits.
  • Coordinate clinical study status updates for effective reporting to management.
  • Assure that the clinical development team receives high quality, timely deliverables from internal and external vendors.
  • Develop and maintain good working relationships with investigators and study staff; provide training to clinical sites and investigators as needed.
  • Liaise with other functional areas to identify and resolve issues that may jeopardize timely clinical study completion. Facilitate the development and timely implementation of remedial activities as needed.
  • Support the development of Clinical Development SOPs and associated guidelines & templates.
  • Conduct site visits including qualification, initiation, interim monitoring and close-out, as needed.
  • Manage study contract and budget process including milestone payments and invoices related to projects assigned.
  • Coordinate and supervise site monitoring assignments and activities.
  • Evaluate impact on resource needs, study processes and related documents.
  • Assess and communicate resourcing needs to the Director of Clinical Operations.
  • Conduct site feasibility and study start-up activities.
  • Review trip reports as required.
  • Serves as the primary project contact for communication and coordination for the third-party vendors.
  • Escalates study and team issues to the Director of Clinical Operations.
  • Other clinical duties as assigned.

POSITION REQUIREMENTS

  • Bachelor’s Degree in health or biological science required. Master’s Degree is highly preferred.
  • Prior clinical experience with a multi-phase clinical program and/or across multiple phases of clinical drug development is required. Late phase clinical development experience, including successful pivotal and/or registration trials, is highly preferred.
  • 4+ years of demonstration experience performing clinical trial activities in a biotech/pharmaceutical/CRO, clinical research site or related healthcare company.
  • Progressive experience in the management and conduct of clinical research including CIH-GCP requirements, drug development process, budgeting and forecasting,, regulatory compliance, project management, study coordination and leading project teams.
  • Demonstrated expertise of all aspects of clinical monitoring operations/functions, including ICH guidelines for GCP and applicable regulatory requirements, contract research procedures and medical terminology.
  • Demonstrated ability to review deliverables to confirm accuracy and professional presentation.
  • Deep understanding of the drug development process.
  • Strong computer skills, including a solid understanding of Microsoft Office Suite and the ability to learn other applications.
  • Excellent written/verbal communication and presentation skills.
  • Exceptional organizational, problem-solving, facilitation and negotiation skills.
  • The ability to work effectively and cross-functionally with stakeholders across a broad range of scientific disciplines and to manage activities with minimal supervision.
  • Self-motivated with an enthusiastic, positive attitude, and excellent multi-tasking ability.
  • Ability to work effectively both independently and in a fast-paced and collaborative team environment.

Job Type: Full-time

Required education:

  • Bachelor's

Required experience:

  • demonstration: 4 years