Quality & Regulatory / Baltimore, Maryland

Clinical Affairs Manager

Key Responsibilities

  • Establishes and maintains trial master binders, trial site binders, and IRB submissions in accordance with study requirements
  • Acts as liaison with pharma partners for ongoing clinical trial management
  • Collaborates with regulatory affairs teams for Risk Determination and IDE submissions, as appropriate
  • Drafts clinical protocols in collaboration with project teams
  • Performs trial monitoring activities as specified in protocols
  • Represents the clinical affairs function in cross-function project meetings
  • Helps to develop tracking systems to improve workflow and efficiency of clinical trials
  • Perform related duties as assigned by supervisor
  • Maintain compliance with all company policies and procedures
  • Reports to VP, Regulatory & Quality

Required Education & Experience

  • Degree in life sciences or a related discipline
  • At least 3 years experience in clinical research and trial management
  • Working knowledge of international directives applicable to the conduct of trials
  • Experience in precision medicine/​IVD/​companion diagnostic clinical trials highly preferred
  • Excellent verbal and written communication skills, including ability to effectively communicate with internal and external customers
  • Excellent computer proficiency (MS Office – Word, Excel and Outlook)
  • Must be able to work under pressure and meet deadlines, while maintaining a positive attitude and providing exemplary customer service
  • Ability to work independently and to carry out assignments to completion within parameters of instructions given, prescribed routines, and standard accepted practices

Physical Requirements

  • Ability to safely and successfully perform the essential job functions consistent federal, state and local standards, including meeting qualitative and/​or quantitative productivity standards

About Personal Genome Diagnostics

Personal Genome Diagnostics (PGDx) empowers the fight against cancer by unlocking actionable information from the genome. We are committed to developing a portfolio of regulated tissue-based and liquid biopsy genomic products for laboratories worldwide. PGDx was established by internationally-recognized cancer researchers Dr. Luis Diaz and Dr. Victor Velculescu, who are pioneers in the application of innovative genomic technologies for drug development and clinical practice.

Please submit applications (cover letter and resume) to HR@​personalgenome.​com
Special consideration will be given to internal PGDx employees who apply.

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