Clinical Project Manager

Harbinger Health is pioneering the detection of early cancer and enabling foundationally new approaches to cancer screening, diagnosis, and management. Incubated within Flagship Pioneering for three years before launching in 2021, Harbinger combines advances in artificial intelligence with proprietary insights into the biology of early cancer cell formation to identify cancer before it is visible or symptomatic with the aim of developing low-cost, multi-cancer blood tests.

At Harbinger, we intend to lead in shaping this future – creating a proactive paradigm so that people can live cancer-free for longer, adding years to life and life to years. We envision a future where, instead of keeping cancer from spreading, it could be kept from forming, making a cancer diagnosis a routine health problem to be addressed rather than a life-altering event to be feared with profound implications for people, healthcare systems and societies.

Our answer starts with proprietary solutions we are developing with our platform technology. By making cancer screening accessible on a global scale, Harbinger Health has the potential to fundamentally change cancer care, for everyone.

Our lifesaving work is grounded by our principles of rigor and transparency, constructive engagement, inclusiveness, accountability and quality, and a strong commitment to our customers, patients, and each other. These values drive our decisions and actions. We are a highly dynamic, entrepreneurial, and innovation-driven organization seeking collaborative, passionate, and dedicated people to join our team.

Position Summary

Job Description – Clinical Trials Manager

As a Clinical Project Manager (CPM) at Harbinger Health, you will manage one or more clinical trials from initiation to completion leading internal and external cross-functional disciplines. Reporting to the Senior Vice President of Clinical Operations, this role will involve close collaboration with Translational Science, Medical, Data Management, Data Science, Digital, and Laboratory teams. The CPM will be responsible for managing all aspects of clinical studies, ensuring they are conducted in accordance with company objectives and regulatory requirements.

Responsibilities

• Represents and leads the study team to design, develop and deliver the study in compliance with agreed upon timelines, internal SOPs, and regulatory requirements.
• Leads the planning and communication with cross functional teams to ensure proper execution and conduct of the clinical trials.
• Serves as primary contact and resource for CRO and vendor personnel.
• Provides oversight and management of CROs and vendors.
• Oversees and monitors the execution of clinical studies ensuring they are conducted in compliance with agreed upon study plans through regular CRO and/or investigator site contact.
• Monitors progress of clinical activity and reports on progress of assigned clinical trials including study budgets and timelines.
• Monitors status of clinical data collection of assigned clinical trials.
• Ensure trial samples are sent to the Harbinger laboratory in a timely manner and meeting trial deliverables.
• Prepares potential investigator site lists and assists with their evaluation for inclusion in the study.
• Reviews monitoring trip reports.
• Responsible for delivery of clinical trial supplies.
• Reviews and approves study-related plans generated by CROs, vendors and ensures the documentation are in accordance with GCP, regulatory requirements and consistent with the protocol.
• Assist study team with preparation for audits/inspections.
• Participates in the review and finalization of clinical study-related documents such as protocols, protocol amendments and Clinical Study Reports (CSR).
• Manages escalation of study related issues and communicates as appropriate to management.
• Present on-going study updates to Clinical Leadership.
• Contributes to development of Request For Proposals (RFP) and participates in selection of CROs/vendors for outsourced activities.
• Provides oversight for the setup, maintenance, and close out of the Trial Master File and ensures it is complete and inspection ready.
• Ability to anticipate potential study issues and to prepare contingency plans with minimal oversight.
• May provide input as the subject matter expert for assigned studies during regulatory inspections.
• May participate in the preparation, review, updating and training of SOPs.
• May mentor other clinical operations team members.
• Perform other duties as requested by management.
  
  

Basic Qualifications

• Bachelor’s degree in a relevant scientific or health related field.
• 4+ years of experience in clinical trial management in the biotech, pharmaceutical, or diagnostic industry.
• Experience managing CROs and external vendors.
• Excellent communication (oral and written), organizational, and problem-solving skills.
• Self-motivated, with initiative and the ability to take ownership of, and follow through with, tasks with limited direction.
• Effective time management and organization skills with ability to shift priorities
• Excellent Microsoft Office skills.
• Strong attention to detail.
• Working knowledge of ICH guidelines and GCP.
• Ability to work collaboratively with others within and external to the company.
• Willingness to travel as needed.
  
  

Preferred Qualifications

• Oncology experience.
• Experience working in the diagnostics industry.
  
  

Harbinger Health is committed to equal employment opportunity regardless of race, color, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, disability, gender identity or Veteran status.

Recruitment & Staffing Agencies: Harbinger Health does not accept unsolicited resumes from any source other than candidates. The submission of unsolicited resumes by recruitment or staffing agencies to Harbinger Health or its employees is strictly prohibited unless contacted directly by Harbinger Health’s internal Talent Acquisition team. Any resume submitted by an agency in the absence of a signed agreement will automatically become the property of Harbinger Health, and Harbinger Health will not owe any referral or other fees with respect thereto.