Person, Text, Face

Clinical Program Lead

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

About the Job

The Clinical Program Lead, Clinical Operations and Data Management provides comprehensive operational support for FMI’s participation in clinical trials sponsored by biopharma partners, academic partners, and FMI-led trials. This position is responsible for developing, implementing and monitoring the execution plans for the clinical studies they support from initial study intake through final project deliverables. The position maintains proactive, clear and customer-centric communication, day-to-day project management, and operational excellence with a solutions-oriented mindset and a keen focus on problem solving. The Clinical Program Lead works collaboratively with internal and external stakeholders across functions to manage samples, timelines, resource plans and critical path activities, directly impacting the successful implementation and on-going execution of clinical studies.


Key Responsibilities

Study Planning and Start-Up

• Facilitate study intake process with partner/collaborator, evaluate feasibility of study with internal stakeholders and obtain FMI approval to support clinical trial (via CSP, SRC, or PRORECO meeting) with finalized SOW.

• Communicate decisions to external partners and collaborators.

• Support internal FMI study start-up activities including contracting, 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.

• Deliver study start-up training with partner and external clinical trial sites as required.

• Deliver study start-up training with internal stakeholders.

Trial Operations

• Manage the implementation, on-time execution and conduct of FMI support of clinical studies, including the management of milestones, timelines and deliverables, development and management of budget/finances, sample forecasting and invoicing, and management of resources.

• Work and collaborate closely with laboratory teams and Process Specialists to ensure sample tracking and chain of custody is maintained through accessioning through data/report delivery.

• Partner with the Data Management and Data Reporting Team to ensure timely delivery of a quality data product in line with partner expectations and contractual deliverables.

• Identify and mitigate against study risks, escalating as necessary.

• 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, including through creation and updating of detailed dashboards and trackers.

• Provide study updates and escalate as needed to FMI leadership including Clinical Operations Data Management, Alliance Management and Clinical Development.

• Ensure timely documentation, and communication of decisions, and updates on timelines and deliverables.

• Support Laboratory Operations and Process Specialists with sample return and destruction process for partner and collaborator samples.

• Support partner/collaborator and internal process audits.

• Contribute to study close-out reports and close studies within FMI systems.


• Maintain documentation on key study contacts (internal and external).

• Build and maintain relationships with internal and external stakeholders and provide study updates as needed to Clinical Operations and biopharma leadership.

• Lead partner-facing study meetings.

• Maintain an awareness of competitive landscape, changing regulations and guidance, assess the impact on clinical projects, and make modifications as necessary.

• Creatively approach challenges and problem resolution to optimize the conduct of clinical trials.

Process Oversight and Study Compliance

• Support Clinical Operations initiatives to improve study management and data management processes.

• Serve as an FMI resource regarding clinical trial regulations.

• Track, resolve and communicate NCRs/process deviations with direct impact on study operations to partners.

• Initiate CAPAs in conjunction with Process and Training Leads and QA to correct and prevent issues from reoccurring.

• Other duties as assigned.



Basic Qualifications

• Bachelor’s Degree in a scientific field or 4+ years of experience in clinical trial or data management roles in lieu of a Degree, AND

• 2+ years of clinical trial or data management experience in a professional life science environment


Preferred Qualifications

• Masters or Advanced Degree in a business or scientific discipline

• 3+ years of clinical operations experience in the biopharmaceutical or diagnostic industry or an academic medical center

• 1+ 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

• 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

• Excellent attention to detail

• Ability to work well under pressure while maintaining a professional demeanor

• Understanding of ICH GCP regulations and guidelines as they apply to the conduct of clinical trials globally

• 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

Apply Now

Internal applicants, please use your FMI email address.

Please let me know about more jobs like this

Not You?

Thank you

Recommended Jobs

Lead Automation Engineer

Lab Operations 100414 Cambridge Massachusetts United States Second Street, Cambridge, Massachusetts, United States Lab Operations
About the Job The Lead Automation Engineer is responsible for automating and scaling complex workflows and implementing processes for deployment of automated systems in clinical laboratories at multiple sites. This position is involved in all asp...

Office of the CEO Intern (MBA)

Executive 100575 United States United States Executive
About the Job The Intern (MBA), Office of the CEO, partners with the Chief Executive Officer’s office in establishing, triaging, and implementing FMI’s enterprise strategy and business operations. The Intern works collaboratively and cross-functi...

Corporate Counsel

Legal 100174 Cambridge Massachusetts United States Second Street, Cambridge, Massachusetts, United States Legal
About the Job The Corporate Counsel provides legal advice and counsel to the Biopharma and Clinical Operations business units and supports day-to-day initiatives as well as long-term strategies. The role has the primary responsibility of drafting...

Finance & Accounting Intern (Undergraduate)

Corporate Management 100547 Cambridge Massachusetts United States Second Street, Cambridge, Massachusetts, United States Corporate Management
About the Job The Intern, Finance and Accounting role works with many areas of the broader Corporate Management Team, dependent upon the relevant needs of the team throughout the summer. This includes general ledger accounting, cost accounting, a...

Job Alerts

Not You?

Thank you

Learn more about the Medical team here.

Shakti, Foundation Medicine’s Senior Director of Pathology, and Senior Associate Medical Director, discusses the direct link between his daily work and making a positive impact for people with cancer. Hear a about a day in the life of a Pathologist at Foundation Medicine.