Senior Clinical Study Manager Endocyte
Endocyte is seeking a Senior Clinical Study Manager who will be responsible for building a clinical trial plan and overseeing that the trial is conducted in compliance with GCP, FDA, and ICH guidelines, HIPAA requirements, national and local regulations, and Endocyte policies and procedures. The Senior Clinical Study Manager is expected to have broad and extensive knowledge of clinical trial activities and is expected to independently solve a broad range of problems. The Senior Clinical Study Manager may also play a key role in managing, training, and/or evaluating the clinical research project team members across Endocyte, Investigative Sites, CROs and other vendors.
Implementation of the international global clinical trial process via appropriate project and budget planning, resource allocation, and project oversight.
Operations oversight of international clinical research projects. This position will manage multiple studies and requires the ability to manage complex global clinical studies.
Leadership of global clinical operations teams.
Supervision, development and evaluation of the internal clinical operations staff and external Clinical Research Associate (CRA)/Clinical Research Organizations (CRO) teams.
Oversight and maintenance of the quality aspects of clinical trials globally, including training of clinical personnel in relevant Standard Operating Procedures (SOPs) and clinical management systems (Omnicomm, Medidata, Trialworks) and SOP development. May also include quality control of clinical documents.
Works in collaboration to ensure all clinical operations activities are successfully executed on-time and within budget.
The Senior Manager, Global Clinical Operations will recommend hiring and termination of subordinate employees and will administer their performance appraisals, as applicable, in conjunction with the appropriate supervisor.
Must be in possession of a degree (bachelor, MD or PhD) in a related field. 8 or more years oncology clinical research experience. 3 or more years supervisory/management experience.
Strong knowledge of Oncology Research and all clinical phases ? I, II, III, IV.
Must have excellent communication skills; ability to lead, evaluate, judge and make recommendations regarding staff and clinical programs.
Must have demonstrated knowledge of, and competence in, application of FDA/GCP/ICH guidelines.
Has demonstrated the use of excellent communication skills, command of medical terminology and of the application of scientific/medical and clinical concepts used to conduct Phase I-IV clinical trials.
Has demonstrated the knowledge and ability to effective manage a clinical trial with minimal supervision.
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