Clinical Trial Manager/ Senior Clinical Trial Manager, Clinical Operations

Location
94080, South San Francisco
Posted
Nov 02, 2018
Required Education
Bachelors Degree
Position Type
Full time

The Clinical Operations department at Calithera Biosciences is looking for a Clinical Trial Manager who will be involved in the startup and management of early phase clinical studies in oncology. We are looking for someone who has great communication skills and can function in this role fairly independently.

Company Background

Calithera is focused on discovering and developing small molecule drugs that slow tumor growth through controlling key metabolic pathways in the tumor and immune cells.

Tumor metabolism and tumor immunology are promising new interrelated fields for cancer drug discovery. Recent clinical successes have demonstrated the potential to slow abnormal cell growth and create fundamentally new therapies for cancer patients. Our investigational onco-metabolism medicines take advantage of the specific metabolic requirements of tumor cells and cancer-fighting immune cells.

Calithera’s discovery and development efforts are focused on diseases for which new treatments are urgently needed for patients suffering from renal cell carcinoma, triple negative breast cancer and other tumor types.

Duties and Responsibilities

  • Manage the day to day functional activities associated with the clinical trial(s).
  • Start-up activities: Assessing site feasibility, manage vendor selection process and be a part of vendor contract and budget negotiation.
  • Manages study timelines, budget, and resource allocation
  • Vendor Selection and oversight
  • Proactively identifies project risks and manages issues to resolution
  • Maintains effective relationships with clinical collaborators and clinical site personnel
  • Analyzes information, and utilizes prior clinical experience and problem solving skills to ensure the best possible outcome for the clinical research program
  • Proactively participates in all aspects of financial management of the trial(s): budget setting, tracking payments and forecasting
  • Drive Clinical data review activities- data listing review, protocol deviation review, trend review.
  • Participate in Site Initiations, Co-monitoring, and site close out activities.
  • Contributes significantly to clinical study documentation including clinical protocols, statistical analysis plan, clinical narratives and clinical study report
  • Works closely with Medical Monitor to develop and implement trial-specific patient recruitment strategies to identify appropriate patients and enroll trials efficiently
  • Assist in the quality control of clinical documentation.
  • Mentor CRAs and Clinical Assistants.
  • Development of department SOPs.
  • Collaborate with department members to identify Clinical Operations process, needs, and lessons learned.

Qualifications and Requirements

  • Bachelor’s degree or higher with a minimum of 7 years directly related experience. 
  • Proactively identifies project risks and manages issues to resolution
  • Maintains effective relationships with clinical collaborators and clinical site personnel
  • Analyzes information, and utilizes prior clinical experience and problem solving skills to ensure the best possible outcome for the clinical research program
  • Proactively participates in all aspects of financial management of the trial(s): budget setting, tracking payments and forecasting
  • Travel: 20-40%
  • Local candidates strongly preferred

Calithera Biosciences, Inc. is an equal opportunity employer & prohibits unlawful discrimination based on race, color, religion, gender, sexual orientation, gender identity/expression, national origin/ancestry, age, disability, marital and veteran status.