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SalarySENIOR CLINICAL TRIAL MANAGER
Day One Biopharmaceuticals is an emerging, mission-driven, drug development company intentionally designed to identify, clinical evaluate, and successfully commercialize novel treatments for pediatric oncology patients, and ultimately to expand those benefits to patients of all ages. For more information, please visit our website at http://www.dayonebio.com.
POSITION SUMMARY:
The Senior Clinical Trials Manager is accountable for the day-to-day operational oversight of at least one Clinical Trial in all Regulatory phases, including trial start-up, conduct, and close-out activities in accordance with the protocol, standard operating procedures (SOP), good clinical practices (GCP) and other applicable regulatory requirements. This activity includes management of Clinical Research Organization (CROs) and support vendors.
This position has the potential to be fully remote. Occasional travel will be required for in person meetings.
ESSENTIAL DUTIES AND RESPONSIBILITIES:
- Manages Clinical Operations trial activities for at least one Clinical Trial
- Responsible for overall study project management of a Clinical Trial(s) including:
o Projection and management of study timelines
o Creation and management of Clinical Trial budgets
o Ensures timely reporting of study metrics to Day One line and/or executive management
o For outsourced studies, manages the CRO and any supportive vendors
- Leads Day One cross-functional study management teams (SMT); is responsible for the timely setting of agendas, effective conduct of SMT meetings and timely issuance of meeting minutes
- Provides input on study-related meetings, including vendor selection, project kick-off, CRO project meetings, functional area-specific meetings, and Investigator meetings
- Ensures investigators and site coordinators are appropriately trained for the study, and that documentation in this regard is collected and filed
- Ensures proper training of the CRO and supporting vendors on the protocol
- Reviews and approves site monitoring visit reports in accordance with the study Monitoring Plan; escalates risk findings according to the Study Plan or Issue Escalation Plan
- Monitors CRO performance using standard Key Performance Indicators (KPI) to ensure compliance to Scope of Work; tracks KPIs for site GCP/study compliance and develops corrective action plans as required
- Active participant in selection and initiation of site
- Provides input for definition of new or revised process development, problem solving, training, etc., as needed
- May lead Clinical Operations-specific process improvement or Clinical projects
- Mentors and manages junior Clinical Operations staff, as applicable
- May attend qualification, initiation, interim monitoring, and close-out visits.
- Occasional domestic US travel up to 25%, and internationally (on an “as needed basis”) in support of trial activities
- Performs all responsibilities in accordance with Standard Operating Procedures, established guidelines and work instructions, and appropriate industry, FDA, ICH guidelines and Good Clinical Practices
QUALIFICATIONS
- BS/BA degree in related discipline; or, Advanced degree in related discipline
- Typically requires a minimum of six (6) years of related experience, contingent on education/training
- Minimum three (3) years’ experience in study management is preferred, or equivalent experience gathered in a previous Clinical Trials management role
- Oncology experience is required
- Experience as a Clinical Research Associate is preferred
- Direct CRO management is preferred
- Extensive clinical operations knowledge and cross-functional understanding of Clinical Trial methodology
- Exhibits ability to learn and apply foreign regulations to the Clinical Trial/research process
- Experience developing trial plans (eg., site monitoring, communication, and issue escalation)
- Knowledgeable in CRF design, interactive response technology (IRT) systems, and clinical supply logistics
- Knowledgeable in Good Clinical Practice requirements and their application to the conduct of clinical studies in the United States and internationally
- Organizes and prioritizes numerous tasks and completes them under time constraints
- Frequently applies strong analytical, organizational, and communication skills
- Working knowledge of MS Office and MS Project
- Detail-oriented
- Ability to work either independently or in a team environment
- Works on assigned problems of complex scope where analysis of situation or multiple factors is required
- Exercises judgment within defined procedures and practices to determine appropriate action
- Builds productive internal and external working relationships
The preceding job description has been designed to indicate the general nature and level of work performed by employees within this classification.
COMPENSATION AND BENEFITS
The salary range for this position is $165,000 - $175,000. Day One Bio considers a range of factors when determining base compensation. These considerations mean actual compensation will vary.
Please visit https://www.dayonebio.com/benefits to see our competitive benefits.
DISCLAIMER
Day One is committed to providing an environment of mutual respect where equal employment opportunities are available to all applicants without regard to race, color, religion, sex, pregnancy (including childbirth and related medical conditions), national origin, age, physical and mental disability, marital status, sexual orientation, gender identity, gender expression, genetic information (including characteristics and testing), military and veteran status, and any other characteristic protected by applicable law.
Employment is conditioned upon full vaccination from the COVID-19 virus, including submission of documented proof thereof, as of the start date. Day One Biopharmaceuticals will comply with applicable law regarding the reasonable accommodation of individuals who are not vaccinated because of a disability and/or sincerely held religious belief.
Recruitment & Staffing Agencies: Day One Biopharmaceuticals does not accept unsolicited resumes from any source other than candidates. The submission of unsolicited resumes by recruitment or staffing agencies to Day One Biopharmaceuticals or its employees is strictly prohibited unless contacted directly by Day One Biopharmaceutical’s internal HR team. Any resume submitted by an agency in the absence of a signed agreement will automatically become the property of Day One Biopharmaceuticals, and Day One Biopharmaceuticals will not owe any referral or other fees with respect thereto.
