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Our Medical team’s culture of curiosity and service supports its mission to ensure that each patient receives the right treatment for their unique cancer. 

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Manager, Clinical Operations

  • Seaport Blvd., Boston, Massachusetts, United States
  • Full Time

About the Job

The Manager, Clinical Operations, is responsible for leading a team of individuals, which includes Clinical Program Leads (CPLs), Sr. CPLs, and Principal CPLs. This position provides comprehensive strategic and operational study management of FMI’s profiling and monitoring studies in support of clinical trials sponsored by BioPharma partners, Academic partners, and FMI led trials. The Manager, Clinical Operations provides leadership and direction to CPLs and ensures consistent implementation of Clinical Operations strategy. This role will instill in their team proactive, clear, and customer-centric communication, day to day project management, as well as, operational excellence and oversight of clinical trials. This position will strategically manage a portfolio of studies independently and efficiently and work cross-functionally with internal stakeholders across a portfolio of Partners studies.

Key Responsibilities

  • Team Management - Provide leadership and direction to Clinical Program Leads (CPLs, Sr. CPLs, Principal CPLs):
    • Recruit, manage, train and develop staff.
    • Motivate and manage team members through setting of individual goals, providing on-going feedback, and performance evaluations.
    • Delegate and provide general oversight of collaborations by providing program management level guidance to direct reports.
    • Provide matrix support for staff in Clinical Operations on design initiatives to enable critical thinking, planning, prioritization, adherence to study needs and escalation as needed.
    • Facilitate team meetings by creating agendas, identifying priorities/working groups and distributing communications/minutes.
    • Oversee staff expenditures.
    • Manage resources according to department strategy.
    • Review staff deliverables.
    • Maintain knowledge of HR Corporate policies and procedures.
  • Study Management, Cross-Functional Leadership & Collaboration:
    • General Duties:
      • Support all new Partnership onboarding assigned to Team.
      • Meet with Clinical Data Operations Supervisor for ongoing studies to ensure proper oversight and resourcing.
      • Build and maintain relationships with internal and external stakeholders and provide study and team updates as needed to Medical and BioPharma leadership.
      • Lead process improvement, resourcing, and risk mitigation projects.
    • Study Management:
      • Lead study intake process with partner/collaborator, evaluate feasibility of study with internal stakeholders, and obtain FMI approval to support clinical trials with finalized SOW.
      • Lead internal FMI study start-up activities including contracting, IRB submission and approval, finalization of study materials including manuals, study specific requisition forms/kits, project specific plans, and sample processing guidelines.
      • Collaborate with partner to establish working approach, including optimization of communication and sharing of tools.
      • Develop and deliver study start-up training with partner, internal stakeholders, and external clinical trial sites as required.
      • Manage the implementation, on-time execution, and conduct of FMI Profiling and Monitoring studies; including the management of milestones, timelines and deliverables, development and management of budget/finances, sample forecasting and invoicing, and management of resources.
      • Oversight of cross-functional study team members to ensure initiation and execution of the clinical program within approved budget and timelines.
      • Engage in problem solving as needed related to sample receipt, accessioning, tracking, genomic analysis, report generation, and dissemination.
      • Effectively track and communicate program/study progress to Partners with ability to create and update detailed dashboards and trackers.
      • Provide study updates across partner portfolio and escalate as needed to FMI leadership, including Clinical Operations and Data Management, BioPharma, and Clinical Development.
      • Support Partner/Collaborator and internal process audits.
      • Contribute to study close-out reports and close studies within FMI systems.
  • Process Oversight and Study Compliance:
    • Lead Clinical Operations initiatives to improve clinical operations processes.
    • Serve as an FMI resource regarding clinical trial regulations.
    • Track, resolve, and communicate NCRs/process deviations with direct impact to clinical trials to partners.
    • Initiate CAPAs in conjunction with Strategic Operations and QA to correct and prevent issues from reoccurring.
  • Communication/Other:
    • Build and maintain relationships with internal and external stakeholders and provide study updates as needed to Medical and BioPharma leadership.
    • Lead partner-facing operational or study team meetings.
    • Awareness of competitive landscape, changing regulations, and guidance with ability to assess the impact on clinical projects and make modifications as necessary.
    • Ability to creatively approach challenges and problem resolution to optimize the conduct of clinical trials.
  • Other duties as assigned.

Qualifications

Basic Qualifications

  • Bachelor’s Degree or equivalent in scientific field or equivalent combination of education, training, and experience
  • 6+ years of Clinical Operations experience in a professional life sciences environment
  • 0-3 years of experience with direct people management or leading a team

Preferred Qualifications

  • Master’s Degree or Advanced Degree in a business or scientific discipline
  • 5+ years of Clinical Operations experience in the biopharmaceutical or diagnostic industry, or in an academic center
  • 2+ years of professional or academic experience:
    • In clinical oncology trials
    • In a Clinical Research Organization (CRO) or lab vendor environment
    • Handling complex clinical data sets including genomic data
  • In depth knowledge of drug development process and keen understanding of ICH GCP regulations and guidelines as they apply to the conduct of clinical trials globally
  • Knowledge and experience working in MS Office Suite
  • Demonstrated history of successfully managing multiple concurrent initiatives and maintaining one’s own workflow in a fast-paced, dynamic environment
  • Demonstrated evidence of success working in a cross-functional environment; able to build strong relationships
  • Strong organizational skills
  • Ability to work well under pressure while maintaining a professional demeanor
  • Excellent attention to detail
  • Understanding of HIPAA and importance of patient safety and data privacy regulations and guidelines
  • Commitment to reflect FMI’s values: Patients, Passion, Innovation and Collaboration

#LI-Hybrid

 

Please be aware that Foundation Medicine mandates COVID-19 vaccination of all employees regardless of work location. Accommodations may be made in accordance with applicable law.

 

About Foundation Medicine

Foundation Medicine, Inc. (FMI) began with an idea—to simplify the complex nature of cancer genomics, bringing cutting-edge science and technology to everyday cancer care. Our approach generates insights that help doctors match patients to more treatment options and helps accelerate the development of new therapies. Foundation Medicine is the culmination of talented people coming together to realize an important vision, and the work we do every day impacts real lives.

Confidence, or the belief that we need to check every box before applying for a job, can sometimes hold us back from going after a role that inspires us. At Foundation Medicine there's no such thing as the 'perfect' applicant, and our company is a place where every employee can make an impact and continue to grow whatever background they may have or path they may have taken. So, as long as you meet the basic qualifications for a role, please apply if you see a position that would make you excited to come into Foundation Medicine every day and help us transform cancer care.

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Foundation Medicine is proud to be an Equal Opportunity and Affirmative Action employer and considers all qualified applicants for employment without regard to race, color, religion, sex, gender, sexual orientation, gender identity, ancestry, age, or national origin. Further, qualified applicants will not be discriminated against on the basis of disability or protected veteran status. We also consider qualified applicants regardless of criminal histories, consistent with legal requirements. See also FMI’s EEO Statement and EEO is the Law and Supplement. If you have a disability or special need that requires accommodation, please let us know by completing this form.  (EOE/AAP Employer)

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