Quality Recruiting. Established Experts.

Expert Clinical Manager

Reference Number: 3134
Location: Northeast

Our client is a major global healthcare company.  They have asked us to assist them in their search for an Expert Clinical Manager.

Major tasks and responsibilities will include:

 

  • Responsible for operational aspects of one or more clinical trials (phase I-IV, Expanded Access, Investigator Initiated, registries and Compassionate Use) under the leadership of the CTH. Supports all scientific aspects of clinical trials as assigned. Responsible for program level activities as assigned with an entrepreneurial approach which requires the ability to multi-task on a wide spectrum of activities with an overall external focus.
  • Contributes to or manages simple clinical trial with minimal supervision by providing input and contribute to the development of protocols and related documents, in the ongoing scientific review of clinical data, and in trial data analysis, reporting and publishing. Prepares training materials and presentations related to the planning and conduct of the trial.
  • Manages simple clinical trial under supervision from the senior clinical operations team. Writes CTT meeting minutes. May deputize for the CTH at certain meetings. Ensures all assigned operational trial deliverables are met according to timelines, budget, operational procedures and quality standards, SOPs and Business Guidance.
  • Contributes to the ongoing scientific review of the clinical data and support trial data analysis, reporting and publishing.
  • Assists in the preparation of clinical outsourcing specifications. Responsible for management of Contract Research Organizations (CROs) and ensures adherence to scope of work within timelines and budget.
  • Supports the development, management and tracking of trial budget working closely with the appropriate partners. Accountable for accuracy and timeliness of trial information in all trial databases and tracking systems.
  • Contributes to the development of clinical sections of regulatory documents like Investigators’ Brochures, safety updates etc.
  • Participates in the on-boarding and training of new staff. May serve as faculty member for training programs.
  • Responsible for MRC process as directed by GMA medical lead. Contributes to the management of third-party Investigator Initiated Trials (ITT), Regional and Locally Sponsored the company’s Trials – provides feedback on study proposals, reviews submitted study concepts/protocols for core requirements. Collaborates with local CPOs and regions to track study progress, updates databases and manages budget. Ensures compliance with the company’s SOPs, Business Guidance and regulatory requirements.
  • Supports Individual Patient Support Program as assigned. Manages physician request, provide treatment plan guidance, ensure compliance with SAE reporting, and manage drug supply.
  • Participates in assigned initiatives.

 

We seek candidates with the following qualifications:

 

  • A degree in health or life sciences.
  • At least 3 years of technical and operational experience in planning, executing, reporting and publishing clinical studies in a pharmaceutical company or contract research organization.
  • Proven ability to work independently and ability to collaborate and work effectively in teams.
  • Ability to support more than one clinical trial.
  • Knowledge of Good Clinical Practice and clinical trial design.
  • Immediate statistical and regulatory process knowledge required.
  • Basic knowledge of hematology/oncology/endocrinology therapeutic areas is preferred.

 

 

Do you have the skills and experience we seek and want to advance your career with one of the world’s leading companies? If so, please email your resume as a Word attachment to us, reference 3134. No calls or faxes, please. Include your daytime phone number and we will contact you confidentially or reply to your email.