Job Description

Essential Duties/ Responsibilities

• May serve as a medical monitor for clinical trials of low complexity or provide support for medical monitoring activities on trials of increased complexity; including the oversight of all aspects of trial conduct, working closely with Medical Safety, Pharmacovigilance, Data Management, Quality, Regulatory and the study management team
• Protocol implementation including site identification and communication, attendance at investigators' meetings, correspondence with sites including IRBs, and interaction with operation's teams
• Cross-functional interaction with all of the disciplines necessary for successful study implementation: pre-clinical, manufacturing, quality assurance, regulatory, medical affairs, marketing, legal, biostatistics and data management, pharmacovigilance, and clinical operations
• Data compilation for efficacy and safety evaluation
• Work closely with the project and study teams to deliver enhanced efficiencies and quality around tactical deliverables, IND and other regulatory submissions, protocol development, amendments and all supporting documents, PK/PD and clinical data collection and analysis, investigator and site communications, study reports and publications.
• Key clinical representative in cross-functional sub-team meetings.
• In collaboration with the study team, author, develop, and amend clinical study protocols, consent forms, case report forms and ancillary study documents.
• Work with Clinical Operations and Data Management in database review, query and clean-up activities in real-time and prior to database lock.
• Preparation of abstracts, posters, oral presentations, manuscripts and clinical study reports.
• Contribute to the preparation for development advisory boards as needed.
• Represent the company at congresses and investigator meetings as needed.
• Demonstrated understanding of clinical study conduct, including all relevant regulations (GCPs etc)
• Demonstrated ability for critical thinking and attention to detail
• Demonstrated effective oral and written communication skills
• Demonstrated ability to work well in a team environment, and lead moderately complex projects
• Demonstrated independence, initiative and ability to work well in a fast-paced dynamic environment
• Ability to travel (approximately 10%) to investigative sites, regulatory agencies, and to attend major oncology meetings

Requirements

• Demonstrated understanding of clinical study conduct, including all relevant regulations (GCPs etc)
• Demonstrated ability for critical thinking and attention to detail
• Demonstrated effective oral and written communication skills
• Demonstrated ability to work well in a team environment, and lead moderately complex projects
• Demonstrated independence, initiative and ability to work well in a fast-paced dynamic environment
• Ability to travel (approximately 10%) to investigative sites, regulatory agencies, and to attend major oncology meetings
• Medical or healthcare degree (MD or foreign equivalent, PharmD, PA-C, Nurse Practioner, and three years of relevant industry or academic experience in clinical research and conduct of clinical studies
• Experience in oncology and/or hematology preferred