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Clinical Trial Manager / CPM

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Location
MA
Salary
$100,000 - $150,000
Job Type
Direct Hire
Date
Aug 23, 2016
Job ID
2380355
We are looking for Clinical Study Leads to help us initiate and manage Ph I-II, global and/or domestic oncology trial(s). The position will be responsible for planning, implementing and managing trials, working as part of a dynamic clinical development team. If you enjoy a start up environment and are looking to contribute to a very talented clinical team, we are the company for you.  For the right person, we are flexible with title for the position and will consider Senior Manager through Director level candidates.
  • Develop, manage, and troubleshoot study timelines, trial metrics, vendor selection, and regulatory documentation. 
  • Drive contract negotiation and manage contract, budgets and payments.   
  • Manage priorities of team, CRO, phamacovigilence, data management vendors, clinical sites, contract monitors, and lab vendors to deliver study results on corporate timelines. 
  • Develop trial materials including study protocols, eCRF design and completion guidelines, laboratory manuals, Informed Consent Forms, training materials and study manuals; site initiation training; data management/validation plans; safety management plans. 
  • Author and/or review of clinical trial protocols, amendments, ICF, IB, annual reports, and internal SOPs. 
  • Author and drive completion of clinical study report and publications with clinical team and external investigators. 
  • Perform activities in accordance with GCP, ICH guidelines, and internal SOPs. 
  • Oversee monitoring activities at clinical CROs; attend co-monitoring visits with contract CRAs as required, including qualification, initiation, interim, and close-out study visits. 
At least 7 years’ experience in clinical research in Pharmaceutical or Biotechnology Industry environment with at least three (3) years’ experience in clinical trial management. Extensive experience in all aspects of clinical trial planning and start up (including budget and resource planning), and in executing the complete range of clinical trial activities, from start up through final trial report. Proven track record having successful management of domestic and international trials, oncology experience is required.
Skills & Competencies:
·     Solid leadership skills and influencing skills
·       Ability to manage multiple projects and conflicting priorities, excellent multi tasking and communication skills
·       Excellent troubleshooting and problem solving skills
·       Fluency in English (oral and written)
·       Position requires flexibility for both domestic and international travel, may be up to 10-15% of time, as necessary