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Associate Director, Clinical Operations

Cambridge, Massachusetts

Post Date: 09/14/2017 Job ID: 1650 Job Category: Clinical: Clinical Operations and Development

This position reports into the Senior Director of Clinical Operations.  The right candidate will possess an understanding of Clinical Operations for successful execution of multiple clinical trials across therapeutic indicates including oncology and hematology and in various phases of development.

Job Responsibilities:
  • Responsibilities of this position involve the day to day management and oversight of clinical trials in collaboration with a dynamic Clinical Development team. 
  • As an Associate Director, provides management across multiple studies and clinical operations aspects of a drug development program.
  • Independently manages and supervises of the operational aspects of company’ s clinical trials, including vendors such as CROs, central labs, biomarker and specialty laboratories, and clinical trial sites.
  • Leads CRO and other vendor selection and reviews contracts/work orders
  • Provides mentoring to junior team members and/or management and development of direct reports, as required.
  • Reviews metrics and Key Performance Indicators to ensure oversight of clinical trial progress.
  • Leads SOP and process development activities for Clinical Operations functions.
  • Manages clinical program budgets and execution program timelines.
  • Oversees in the day to day supervision of clinical trial execution, with a focus on site start up, patient enrollment, monitoring, compliance, and data flow metrics from the clinical sites, CROs and central labs
  • Leads investigator meetings, kick-off meetings, monitoring training, and various CRO (or other vendor) meetings.
  • Leads the development of clinical trial protocols, amendments, CRFs, IRB/Ethics applications, and recruitment materials. 
  • Presents trial status and clinical operations strategy to project team and management.
  • Reviews and approves specific study documents e.g. informed consent forms, study guidelines, operations manuals, training materials.
  • Leads Clinical Operations project team meetings.
  • Approves action plans to address protocol compliance, safety, data and administrative issues with investigational sites and CROs.
  • Attends site visits to ensure oversight of CRO and KOL development.
  • Participates in the preparation of presentations of trial data for internal and external parties (management review, scientific meetings, and advisory boards).

Qualifications/ Requirements
  • Minimum Education Required: Bachelor’ s degree in a scientific discipline required. Advanced scientific degree is preferred.
  • The candidate should ideally have 8-12+ years in trial management with a sponsor company managing various phase clinical trials.  
  • Experience in clinical trial conduct in multiple phases of development across several therapeutic areas is required.
  • Experience in CRO, vendor and laboratory selection and oversight is required.
  • Experience in the management across a development program and participation in NDA/sNDA filing is preferred.
  • Motivated self-starter who is capable of flourishing in a fast-paced small company environment.
  • Creative problem solver with excellent communication and public speaking skills.
  • Strong interpersonal and organizational skills are needed, with a high degree of attention to detail.  Ability to interact well with individuals at all team levels (e.g., Clinical scientist, Project leader, Physician, etc.).
  • Ability to travel for up to 30% of time, both domestic and international, may be needed.
  • Detailed knowledge of GCP and current US FDA regulations, and knowledge of other relevant global regulatory requirements a plus.

Rachel Ambroziak
Senior Recruiter

Rachel brings nearly 15 years of experience to The Steely Group, and specializes in Clinical Staffing. She is respected greatly for her tenacity, determination and great attention to detail. Her success in the recruiting industry is based, in part, on her passion for understanding the needs of both clients and candidates, as well as a commitment to providing exceptional customer service.
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