Global Clinical Trial Manager Temp

Cytomx Therapeutics South San Francisco , CA 94080

Posted 2 months ago

Global Clinical Trial Manager (TEMP)

About CytomX Therapeutics:

CytomX Therapeutics, Inc. is committed to changing the treatment of cancer with our novel Probody therapeutic platform. Our commitment to transforming lives with safer, more effective therapies is driven by our curiosity and passion for innovation and our belief that by acting with integrity in an honest, respectful, ethical manner, we have the power to change lives. Our workplace embodies collaboration, open communication, celebrating our successes and holding each other to the highest possible standards. CytomX has a broad pipeline comprised of 4 clinical-stage programs and others in development and is located in South San Francisco, California, the birthplace of biotechnology. Learn more at www.cytomX.com

Location: South San Francisco, California

Reporting Relationship: Reports to Director, Clinical Operations

The Opportunity:

The Global Clinical Trial Manager is responsible for providing operational and scientific support for Clinical studies and Development activities. This cross-functional role includes working directly with the study team and vendors to ensure execution on the clinical strategy, as well as ensuring the timely monitoring and cleaning of clinical data to assisting with writing manuscripts (paper, abstracts, posters, study report etc.). The Global Clinical Trial Manager will report to the Director, Clinical Operations and collaborate closely with Clinical Development, Clinical Pharmacology, Biostatistics, Data Management and Project Management.

Major Duties/Responsibilities

  • Develops, leads and coordinates clinical trial operational activities and manages their execution to ensure completion according to timelines, anticipating potential study problems and preparing contingency plans as needed

  • Work directly with vendors to ensure development and delivery of study documents, plans, and manuals

  • Partners with study team to ensure trial activities are documented in the trial master file in accordance with regulatory requirement and SOPs

  • Coordinate cross functionally and manage the development of, protocols, amendments, and ICF's

  • Work collaboratively with project teams to incorporate the therapeutic directions and patient selection strategies into clinical protocols

  • Develop and cultivate relationships with external partners such as clinical investigators, clinicians, scientists, and vendors

  • Collaborate with the clinical development team to ensure appropriate data review and accurate data reporting

  • Work cross functionally to assist in the preparation of data for scientific publications including posters, abstracts and manuscripts

  • Support the implementation of new clinical systems/processes

Education/Experience:

  • A minimum of a bachelor's degree in clinical, biological, mathematical sciences or related field is required, an advanced degree is preferred. Equivalent experience may be accepted in lieu of the degree requirement
  • A minimum of 3 years pharmaceutical development experience is strongly preferred

Professional Requirements:

  • Excellent written and verbal communication skills are required

  • Experience and understanding of ICH and GCP is preferred

Personal Characteristics:

  • Must have demonstrated problem solving abilities and strong organizational skills

  • Must be a demonstrated self-starter and team player with strong interpersonal skills

CytomX is an equal opportunity employer. Employment decisions are based on merit and business needs. CytomX will not discriminate against any job applicant because of race, color, national origin, ancestry, gender, sexual orientation, age, religion, creed, physical or mental disability, gender identity, medical condition, pregnancy, marital status, veteran status, or any other characteristic protected by federal, state or local law.


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Global Clinical Trial Manager Temp

Cytomx Therapeutics