Manager, Clinical Study Operations
Beacon Biosignals · Boston, MA · 3 wk ago
RemoteRemoteResearch$115k–$135k/yrFull-time
We need to output HTML fragment with sections: About the role, Responsibilities, Requirements, Qualifications, Skills, Benefits, Pay, Schedule. Only include sections that have real specific content. We must not repeat job title as heading. No Job ID etc. Remove boilerplate. Must preserve all substantive info.
We need to parse the posting.
Let's extract sections:
- About the role: description of company and role overview. The first paragraph: "Beacon Biosignals is transforming precision medicine for the brain..." up to "This role reports to the Director, Clinical Study Operations." That's about the role.
- Responsibilities: list of duties: "You will manage a group of direct reports..." etc. Also "What success looks like" bullet list. Also "Represent ClinOps ahead of study execution..." etc. So we can combine responsibilities.
- Requirements: maybe "What you will bring" list: experience, degree, managing people, travel, ownership of lifecycle, GCP knowledge, etc. That's requirements/qualifications.
- Qualifications: maybe overlapping with requirements. Could separate: Qualifications: Bachelor's or advanced degree, etc. But we need to avoid duplication. The instruction: prefer few substantive sections over many thin ones. So we can combine Requirements and Qualifications into one section? But they ask to use headings for those categories if content exists. We could have Requirements (experience, skills) and Qualifications (education). However we can also put all under Requirements. But we need to follow instruction: Use headings for section headings (e.g. About the role, Responsibilities, Requirements, Qualifications, Skills, Benefits, Pay, Schedule). So we can include those headings only if we have content.
We have content for About the role, Responsibilities, Requirements (experience), Qualifications (education), Skills (maybe cross-functional communication, bias toward simplicity, asynchronous work), Benefits (equity, PTO, other benefits mentioned), Pay (salary range), Schedule (maybe not mentioned; no explicit schedule like full-time, remote, travel up to 15%). Travel is mentioned but not schedule. Could we infer schedule? Not given. So we should not create Schedule section if no specific content. Benefits: they mention equity, PTO, other benefits. That's specific enough. Pay: salary range $115k-$135k. So include Pay.
Skills: maybe list of skills: cross-functional communication, ability to align Product, Engineering, Data Science, comfort with asynchronous, bias toward simplicity, etc. That's specific.
Thus sections: About the role, Responsibilities, Requirements, Qualifications, Skills, Benefits, Pay.
We must not include Schedule.
Now we need to format:
About the role
then... prose. For lists use
- .
We must preserve all substantive information; do not invent or summarize away detail. Must not omit details. So we need to include all details from the posting.
Let's extract details precisely.
About the role:
"Beacon Biosignals is transforming precision medicine for the brain, from clinical development to clinical care. For Life Sciences partners, we offer the leading at-home EEG platform for clinical development of novel therapeutics for neurological, psychiatric, and sleep disorders. Our Diagnostics business is building the most comprehensive at-home platform for precision diagnostics, combining EEG and cardiopulmonary signals to deliver reimbursable assessments for sleep and central nervous system disorders. Together, we're changing the way patients are diagnosed and treated for any disorder that affects brain physiology. Beacon Biosignals is seeking a Manager, Clinical Study Operations to lead a team within our Clinical Study Operations (ClinOps) group. ClinOps is responsible for the end-to-end execution of Beacon's internal and external device-based clinical trials — from feasibility and site start-up through recruitment, enrollment, data collection, monitoring, and close-out. In this role, you will manage a group of direct reports across Clinical Study Operations, overseeing the ClinOps activities on the studies they run — from feasibility and site start-up through data collection, monitoring, and close-out. You will set clear expectations, coach day-to-day execution, escalate risks to leadership before they become problems, and step in directly when a study needs it. Beyond study oversight, you will personally own and drive domain-level ClinOps goals and initiatives — process standardization, tooling, data quality — end to end. You will also represent ClinOps ahead of study execution — in BD conversations, feasibility discussions, and Investigator Meetings — and partner closely with Product, Engineering, Life Science, and BD to keep trials on track and compliant. This role reports to the Director, Clinical Study Operations."
That's the about role.
Responsibilities: The "What success looks like" bullet list plus other duties maybe already covered. But we need to ensure we don't duplicate. The about role already includes many responsibilities. However we can still have Responsibilities section with bullet list of duties: managing direct reports, overseeing ClinOps activities, setting expectations, coaching, escalating risks, stepping in, owning domain-level ClinOps goals (process standardization, tooling, data quality), representing ClinOps in BD conversations, feasibility discussions, Investigator Meetings, partnering with Product, Engineering, Life Science, BD, overseeing ClinOps execution across studies (feasibility, site start-up, enrollment, monitoring, close-out), escalating risks and blockers, owning ClinOps KPIs and goals (execution timelines, enrollment and data quality metrics), tracking progress in Asana, reporting to leadership and cross-functional partners, exercising sound judgment on issue classification and escalation (complaint vs technical-issue calls, device reconciliation/invoicing decisions), leading domain-level ClinOps initiatives end to end (process standardization, tooling rollouts, dashboard/reporting improvements), scoping work, driving with Engineering, Product, Data Science partners, owning outcome, maintaining and improving ClinOps SOPs, work instructions, CTMS practices, driving continuous process improvement, representing ClinOps ahead of study execution in BD conversations, feasibility discussions, Investigator Meetings (operational/tactical), managing Beacon's day-to-day working relationship with sponsors and CRO intermediary, stepping in to represent Beacon directly with sponsor when study lead escalates decision needing strategic alignment or sign-off.
Also "Support onboarding, and ramp-up for your team as it grows." and "Translate Beacon's strategic priorities into a roadmap for your area — sequencing initiatives, process investment, and team growth — and communicate it clearly to your manager and other stakeholders." That's also responsibilities.
We need to include all.
Now Requirements: "What you will bring" list:
- 6+ years of experience in clinical trial operations in biotech, medtech, or pharma (device-based trial experience a strong plus).
- Bachelor's or advanced degree in a clinical or scientific field.
- 1-2+ years directly managing people, with a track record of hiring, coaching, and performance management.
- Ability to travel up to 15% of the time for Investigator Meetings, sponsor engagements, and site visits.
- Demonstrated ownership of the clinical trial lifecycle: start-up, recruitment strategy, enrollment, monitoring, data cleaning, and close-out.
- Working knowledge of GCP, FDA and global regulatory requirements, and experience with SOP development and QMS practices (Qualio or similar).
- Comfortable ramping up quickly on proprietary CTMS/eTMF tooling (e.g., internal study configuration platforms, eBinder systems, LMS) in a fast-moving startup environment — prior specific-tool experience not required.
- Experience working with CROs and vendors: selection support, day-to-day oversight, and relationship management.
- Strong cross-functional communication skills, with the ability to align Product, Engineering, and Data Science partners in a fast-paced startup environment.
- Comfortable operating asynchronously across time zones in a remote-first, distributed organization.
- A bias toward simplicity — able to introduce the right level of process without adding unnecessary complexity.
We could split Requirements (experience, travel, ownership, GCP, tooling, CRO experience) and Qualifications (education). But we can also combine. However they ask to use headings for Requirements and Qualifications if content exists. We have both.
Thus Requirements: maybe the experience-based items (6+ years experience, 1-2+ years managing people, ability to travel, demonstrated ownership, working knowledge of GCP, comfortable ramping up on tooling, experience with CROs/vendors, strong cross-functional communication, comfortable operating asynchronously, bias toward simplicity). Qualifications: Bachelor's or advanced degree in a clinical or scientific field.
Skills: maybe cross-functional communication, ability to align Product, Engineering, Data Science, bias toward simplicity, asynchronous work, etc. But those overlap with requirements. Could treat Skills as separate: maybe "Strong cross-functional communication skills, ability to align Product, Engineering, and Data Science partners", "Bias toward simplicity", "Comfortable operating asynchronously". However we already have those in Requirements. To avoid duplication, we could put those under Skills and keep Requirements more about experience and qualifications. But we need to preserve all info; duplication is okay? The instruction: "Preserve ALL substantive information; do NOT invent or summarize away detail." Duplication is not prohibited but could be considered redundant. Better to avoid duplication by distributing items appropriately.
Let's decide:
- About the role: company overview and role summary.
- Responsibilities: all duties and success metrics.
- Requirements: experience-based items (6+ years experience, 1-2+ years managing people, ability to travel, demonstrated ownership of lifecycle, working knowledge of GCP, experience with CROs/vendors, comfort ramping up on proprietary tooling, strong cross-functional communication, comfortable operating asynchronously, bias toward simplicity). Also maybe "Experience working with CROs and vendors: selection support, day-to-day oversight, and relationship management." That's experience.
- Qualifications: Bachelor's or advanced degree in a clinical or scientific field.
- Skills: maybe we could list specific skills like "process standardization, tooling, data quality", "SOP development and QMS practices", "dashboard/reporting improvements", "issue classification and escalation", "managing sponsor relationships". But those are more responsibilities. Could treat Skills as "cross-functional communication, bias toward simplicity, asynchronous work". However those are already in Requirements. Might be better to not have Skills section if it duplicates. But we need to follow instruction: "Prefer a few substantive sections over many thin ones." So we could omit Skills if its content overlaps heavily with Requirements. However we need to include all substantive info; if we omit Skills heading, we still have the info in Requirements. That's acceptable.
Thus sections: About the role, Responsibilities, Requirements, Qualifications, Benefits, Pay.
Now Benefits: "The base salary is one component of the total compensation package, which includes equity, PTO, and other benefits." Also maybe "Beacon's asynchronous work practices support a strong remote experience, with in-person hubs in Boston, New York, and Paris." That's more about work arrangement, could be Benefits? Could be part of Benefits (remote flexibility, hubs). Also "The Clinical Study Operations group is distributed across American and European time zones." That's about work arrangement. Could be Benefits? Might be better to include under Benefits: remote-first, distributed, hubs, equity, PTO, other benefits.
Pay: salary range $115,000 – $135,000.
Now we need to ensure we don't include boilerplate like EEO, legal, etc. Not present.
Now produce HTML.
We'll wrap each section:
About the role
...
. For lists:- ...