Clinical Program Lead

We need to output HTML fragment with sections: About the role? The posting starts with "About The Job". Use

for section headings. We need to include sections only when there is real content. The posting includes: About The Job (intro paragraph). Then Key Responsibilities (list). Then Qualifications (Basic and Preferred). Then salary info (Pay). Also maybe Benefits? It mentions "This position also qualifies for Foundation Medicine's benefits." That's a statement about benefits, but not detailed. Should we include Benefits section? The rule: include a section ONLY when posting has real, specific content for it — never emit a heading followed by filler/placeholder text. "This position also qualifies for Foundation Medicine's benefits." is vague, not specific. Likely we should not create Benefits section because no specific benefits listed. Pay section: we have salary range. So include Pay section with that info. Schedule? Not mentioned. So omit. We need to remove boilerplate like attendance policies etc? The line "Comply with FMI's attendance policies" is part of Qualifications? Actually appears after "Other duties as assigned." then "Comply with FMI's attendance policies". That's minor metadata; we can fold into a short

or drop. Probably drop as it's boilerplate. We need to preserve all substantive information. So include intro paragraph under About the role? The heading "About the role" is appropriate. The intro paragraph: "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." We can put that in

. Then Responsibilities: list items under Key Responsibilities. The posting has subheadings: Study Planning and Start-Up, Trial Operations, Communication/Other, Process Oversight and Study Compliance. We can treat each as maybe separate subheadings? But rule: use

for section headings (e.g. About the role, Responsibilities, Requirements, Qualifications, Skills, Benefits, Pay, Schedule). So only those top-level headings. So we will have a Responsibilities section with

• items. We need to preserve all duties. Could combine subpoints into list items. Might be long but okay. We need to not repeat job title as heading. So no heading for job title. Qualifications: we have Basic Qualifications and Preferred Qualifications. Could combine into a single Qualifications section with two sublists? But rule only allows those headings; we could still have
  • inside Qualifications. Could separate Basic and Preferred as separate
    maybe with a

    intro. That's fine. Pay: include salary range. We must not include sections with filler like "commensurate with experience". The salary description includes "The salary range is commensurate with Foundation Medicine’s compensation practice..." That's filler; we should not include that sentence? The rule: never emit a heading followed by filler/placeholder text (e.g. "commensurate with experience", "not specified", "N/A", "varies", "TBD") and never create Pay/Schedule/Benefits sections unless the posting actually states them. It says we can include Pay section if posting actually states them. It does state salary range. However the description includes filler phrase "commensurate with...". Should we include that sentence? It's not a placeholder; it's explanatory. Might be okay to keep. But to be safe, we could include just the salary range sentence and maybe the bonus line. The rule about filler refers to heading followed by filler text; not about content inside. So we can keep the explanatory sentence. We must remove cookie/navigation/legal/EEO/equal-opportunity/scam-warning boilerplate, duplicated lines, and application instructions. There's none. Now craft HTML. Structure:

    About the role

    ...

    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.
    • 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 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.
    But we have duplicated "Other duties as assigned." appears twice? Actually appears at end of Process Oversight and also after Qualifications? In posting: after Process Oversight and Study Compliance: "Other duties as assigned." then "Comply with FMI's attendance policies". We'll include only once. Now Qualifications:

    Qualifications

    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 the importance of patient data privacy; Commitment to reflect FMI’s values: Integrity, Courage, and Passion.

    We could also use
    but it's okay. Pay:

    Pay

    The expected salary range for this position based on the primary location of Boston, MA is $94,000 - $110,000 per year. The salary range is commensurate with Foundation Medicine’s compensation practice and considers factors including, but not limited to, education, training, experience, external market conditions, criticality of role, and internal equity. A discretionary annual bonus may be available based on individual and Company performance.

    We should not include "This position also qualifies for Foundation Medicine's benefits." as it's vague; we can drop. Now ensure no extra headings like About The Job (we used About the role). Good. Now output only HTML fragment. Check for any duplicated content: we included responsibilities list with many items; ensure we didn't miss any. Let's verify original 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. Communication/Other: - Maintain documentation on key study contacts (internal