Manager of Clinical Research

Catabasis Pharmaceuticals

Clinical

July 21, 2014

We are seeking a Manager of Clinical Research to join the Clinical Operations team at Catabasis.  The role will be a key contributor to the company’s clinical development and primarily responsible for the hands-on management and monitoring of clinical studies in the muscular-skeletal-related clinical therapeutic areas.  This position reports to the Director, Clinical Operations. 

Responsibilities:

  • Oversee the management of the overall activities of relevant CROs, vendors and monitors either in-house or regionally based;
  • Oversee the evaluation of potential clinical investigators and sites
  • Oversee the development and coordinates review of key deliverables, such as the study synopsis, protocol, informed consent forms, study guidelines, operations manuals; CSRs
  • Maintains study timelines
  • Manage escalation of study related issues and establishes appropriate course of action
  • Proven track record of anticipating potential study issues and preparing contingency plans with minimal oversight
  • Responsible for the conduct of training and kick-off meetings with sites and vendors
  • Analyze and develop action plans to address protocol compliance, safety, data and administrative issues with investigational sites and vendors

Qualifications:

  • Minimum 5 yrs. experience of biotech / pharmaceutical clinical operations experience
  • Experience in managing the execution of complex phase 1-3 clinical trials in muscular-skeletal-related clinical therapeutic areas is highly desirable
  • Experience in managing pediatric studies preferred
  • Strong experience in CRO and vendor management to support clinical trials
  • Strong knowledge of FDA regulations and GCP / ICH guidelines regarding clinical trial management
  • Ability to “roll up your sleeves” and individually contribute results to clinical operations and company-wide goals
  • Demonstrated skills in writing/reviewing clinical study protocols, CRF, and study documentation development, CSR’s, regulatory documents (including IND, CTA documents and annual/periodic updates).
  • Bachelor’s degree in health sciences or related field, required; Master’s preferred.
  • Superior verbal and written communication and interpersonal skills, including a positive and professional attitude to tasks and projects
  • Demonstrated ability to meet short-term deadlines and multi-task in a very fast-paced work environment with little direct supervision
  • Demonstrated computer skills using MS Office Suite (Word, Excel, PowerPoint, Outlook and Project) software
  • Ability to travel domestically and internationally

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