Clinical Trials Manager

5 days ago

Detroit, Michigan, United States Barbara Ann Karmanos Cancer In Full time
Job Summary:

As a key member of the Barbara Ann Karmanos Cancer Institute team, we are seeking a highly skilled Clinical Trials Manager to oversee the supervision, oversight, and quality control of Phase I clinical trial staff. The successful candidate will be responsible for the business development of the Phase I Clinical Trials Department and ensuring seamless integration across various teams within the Karmanos and McLaren networks.

Responsibilities:
  • Direct supervision of Phase I clinical trial staff, evaluating performance with input from the Karmanos Vice President, Clinical Trials Office, the Medical Director – Phase I Clinical Trials, and other Management as applicable.
  • Active participation in the recruitment, hiring, discipline, and termination of Phase I clinical trial staff.
  • Implementation and maintenance of a Quality Assurance Program for Phase I clinical trial staff activities, adhering to Standard Operating Procedures (SOPs), Food and Drug Administration (FDA) guidelines, International Conference on Harmonisation (ICH) guidelines, and Good Clinical Practice (GCP) guidelines.
  • Assistance in providing clinical trials information for grant preparation and continuations as needed, managing peer-reviewed grants, and working with sponsors to bring in new clinical trials.
  • Responsible for business development of the Phase I Clinical Trials Office, including setting and monitoring quality metrics, tracking clinical trial portfolio, managing feasibility reviews for incoming potential clinical trials, and working with sponsors to bring in new clinical trials.
Qualifications:
  • Science-based Bachelor's degree required; Master's degree in a health- or a science-related field preferred.
  • Medical and/or science experience/education strongly preferred.
  • Experience with scientific writing preferred.
  • SOCRA or equivalent certification for at least 1 year required; if not held, must agree to obtain within 2 years of hire.
  • Minimum of two years prior management or supervisory experience, including responsibility for hiring, training, discipline, and oversight of professional staff preferably in a clinical research setting.
  • Minimum of five years of experience working in an oncology clinical trials setting at a research institution and/or pharmaceutical company.
  • Experience working in Phase 1 oncology clinical research preferred.
  • Demonstrated record of effectiveness in a management or supervisory position (clinic and/or administrative).
  • Demonstrated leadership abilities and ability to analyze problems and affect resolution.
  • Demonstrated ability to maintain cooperative working relations with internal and external units in a clinical research environment.
  • Demonstrated ability to provide excellent customer service.
  • Demonstrated initiative and attention to detail.
  • Skilled in communicating sensitive/difficult information and maintaining highly confidential information.
  • Proficient in computerized information systems and databases, with expertise in the Microsoft suite.
  • Knowledgeable in internal and external research regulations, GCP guidelines, Code of Federal Regulations, clinical trials monitoring, regulatory compliance, research budgets, etc.

We are an Equal Opportunity Employer of Minorities/Females/Disabled/Veterans.

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