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Clinical Study Manager

Cambridge, MA 02139

Posted: 08/08/2019 Employment Type: Direct Hire Job Category: Clinical: Clinical Operations and Development Job Number: 2381

Responsibilities of this position involve the day-to-day management and oversight of clinical trials in collaboration with a dynamic Clinical Development team. 

Specific Responsibilities include:
  • Independent management of the operational aspects of clients’ clinical trials, including vendors such as CROs, central labs, biomarker and specialty laboratories, and clinical trial sites.
  • Identification and qualification of clinical trial sites and investigators alongside CRO including management of key relationships.  
  • Participation in final decisions for site selection with clients’ team.  
  • Participation 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
  • Management of clinical study budgets and execution timelines.
  • Leads internal team meetings for study management.
  • Facilitation of investigator meetings, kick-off meetings, monitoring training, and various CRO (or other vendor) meetings.
  • Participation in the development of clinical trial protocols, amendments, CRFs, IRB/Ethics applications, and recruitment materials.
  • Attendance at site visits to ensure oversight of CRO monitors and effective collaboration with Investigators and site staff.
  • Review study reports and metrics to ensure timely collection of clinical data, samples, and lab results.
  • Collaboration on SOP development and promotion of standardized clinical business tools.
  • Development and review of specific study documents e.g. informed consent forms, study guidelines, operations manuals, training materials.
  • Development of action plans to address protocol compliance, safety, data and administrative issues with investigational sites and CROs.
  • Participation in the preparation of presentations of trial data for internal and external parties (management review, scientific meetings, and advisory boards).

Qualifications:
  • Minimum Education Required: Bachelor’ s degree in a scientific discipline required. Advanced scientific degree is preferred.
  • The candidate should ideally have 4-6+ years in trial management with a sponsor company managing various phase clinical trials. 
  • Experience in various phases of clinical trials and various therapeutic areas, including oncology, would be helpful.
  • Experience in CRO, vendor and laboratory oversight is required.
  • 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.

Sam Williams
Clinical Recruiter

Sam brings great enthusiasm and a passion for the life sciences to his role as Clinical Recruiter for The Steely Group. Outgoing and driven with a great sense of humor, Sam connects easily with people and prides himself on his ability to cultivate lasting relationships. He values honesty, communication and empathy in a candidate, and has a genuine interest in helping others achieve their professional goals.

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