About the Job

The Sr. Clinical Program Lead, in 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 strategically manages a portfolio of studies independently and efficiently. The Sr. Clinical Program Lead is not only responsible for developing, implementing, and monitoring the execution plans for the clinical studies they support from initial study intake through final project deliverables, but are also responsible for contributing to the design of partner and FMI sponsored research. Activities include: proactive, clear, and customer-centric communication, day to day project management, as well as, operational excellence and oversight of clinical trials. The Sr. Clinical Program Lead will work 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

• Strategically represent Clinical Operations in governance sub-committees (Clinical Subteam of LCT).

• Study Planning and Start-Up:

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

·   Communicate decisions to external partners/collaborators.

·   Contribute to the design of the study.

·   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.

• 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.

·   Oversight of cross-functional study team members to ensure initiation and execution of the clinical program within approved budget and timelines.

·   Understand how to support and deliver the trial endgame, which is the data and reports.

·   Work and collaborate closely with Clinical Program Leads, laboratory teams, and Process Specialists to ensure sample tracking and chain of custody is maintained from accessioning through data/report delivery.

·   Partner with 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 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, 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/Collaborator samples.

·   Support Partner/Collaborator and internal process audits.

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

• Communication/Other:

·   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 Medical and BioPharma leadership.

·   Lead partner-facing study 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.

• Process Oversight and Study Compliance:

·   Lead Clinical Operations initiatives to improve clinical operations and data management 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 Process and Training Leads and QA to correct and prevent issues from reoccurring.

Qualifications

Basic Qualifications

• Bachelor’s Degree or equivalent in scientific field or equivalent combination of education, training, and experience

• 4+ years of Clinical Operations experience in a professional life sciences environment

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