Project Manager, Clinical Operations (Oncology)

San Diego, CA or Remote (U.S.)

  • We are seeking a responsible, dynamic, creative, and highly motivated PM to join our Oncology team. 
  • Biosplice is open to considering remote candidates for this position. 
  • The Senior / Project Manager (PM) will be accountable for leading all program Study Execution Teams (SETs) in support of the approved Lifecycle plan and ensuring the program meets study deliverables consistent with the Protocol(s), and the Clinical Development Plan.
  • The PM will also have overall program oversight for timelines, budgets, quality, resourcing and risk management.
  • The PM will have leadership and/or oversight of sub-teams of the wider Clinical Operations group, such as resource planning, outsourcing, training, quality, standards, processes, SOPs and initiatives. May also lead department, development or cross-functional initiatives and/or serve on governance committees.

Specific Responsibilities

  • Managing timelines with MS Project for programs;
  • Managing budget, budget planning, and budget forecasting for programs;
  • Presenting weekly / bi-weekly updates to management on programs
  • Ensure continual training for all project staff;
  • Leading and Managing cross-functional program leadership teams
  • Managing all vendors including but not limited to CROs & Laboratories;
  • Managing site monitoring and site issue escalation;
  • Authoring monitoring plans and all operational plans;
  • Managing CRAs, CTAs, CRO and Vendor Staff;
  • Authoring pharmacy manuals;
  • Leading investigator meeting(s) and investigator meeting slide development;
  • Providing overall site correspondence approval;
  • Reviewing and tracking of trip reports for monitors;
  • Training CRAs and vendor teams for protocol and operational aspects of the program;
  • Establishing special needs for protocol master files and audit schedule;
  • Serving as primary contact for QA and DM for protocol;
  • Participating in departmental planning sessions and SOP development;
  • Co-monitoring as necessary

Requirements

  • 4 year life sciences or health care related bachelors degree from an accredited university
  • Minimum 6 -8 years of clinical oncology project/study/program management experience
  • Minimum 6-8 years of oncology sponsor experience
  • Proficient in MS Office software
  • Excellent verbal and written communication skills

Please submit your resume or additional inquiries to apply@biosplice.com. Please include the complete title of the position for which you are applying in the subject line of your email. Emails that do not include this information will be disregarded. NO PHONE CALLS PLEASE.